Publications by authors named "Kyle A Perry"

56 Publications

Role of Surgical Innovation in Addressing the GERD Treatment Gap.

Authors:
Kyle A Perry

J Am Coll Surg 2021 Mar;232(3):318-319

Columbus, OH.

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http://dx.doi.org/10.1016/j.jamcollsurg.2021.01.001DOI Listing
March 2021

Tobacco use is not associated with increased risk of recurrent reflux 5 years after laparoscopic anti-reflux surgery.

Surg Endosc 2020 Sep 10. Epub 2020 Sep 10.

Center for Minimally Invasive Surgery, The Ohio State University Wexner Medical Center, 410 W 10th Ave, 558 Doan Hall, Columbus, OH, USA.

Introduction: Tobacco use worsens gastrointestinal reflux disease (GERD). Smoking cessation improves GERD symptoms, but its impact on the efficacy of laparoscopic anti-reflux surgery (LARS) is unclear. In this retrospective cohort study, we hypothesized that non-smokers would demonstrate greater long-term improvements in disease-specific quality of life than active smokers.

Methods: Data were maintained in an IRB-approved prospective database, and patients were stratified according to tobacco use. Postoperative follow-up occurred in clinic and long-term follow-up via telephone interview. Outcomes measured were gastroesophageal health-related quality of life (GERD-HRQL) and GERD symptom scale (GERSS) scores, proton pump inhibitor (PPI) cessation, and satisfaction with surgery.

Results: Two hundred and thirty-five patients underwent primary LARS, and 31 (13%) were active smokers with 18 median pack-years [10-30]. Baseline PPI use (96% vs. 94%, p = 0.64), presence of a hiatal hernia (79% vs. 68%, p = 0.13), esophagitis (28% vs. 45%, p = 0.13), and DeMeester score (41.9 vs. 33.6, p = 0.47) were similar. Baseline GERD-HRQL and GERSS scores and their post-surgical decreases were also similar between groups. PPI cessation was achieved in 92% of non-smokers and 94% of smokers (p = 0.79), and GERD-HRQL scores decreased to 4 [1-7] and 5 [0-12], respectively (p = 0.53). After 59 [25-74] months, GERD-HRQL scores were 5 [2-11] and 2 [0-13] (p = 0.61) and PPI cessation was maintained in 69% and 79% of patients (p = 0.59). Satisfaction with surgery was similar between smokers and non-smokers (88% vs. 87%, p = 0.85). Female gender was significantly associated with increased improvements in GERD-HRQL (p < 0.01) and GERSS scores (p = 0.04) postoperatively but not at long-term follow-up. Patients without a hiatal hernia were less likely to achieve long-term PPI cessation compared to those with a hernia (OR 0.23, p < 0.01).

Conclusions: After 5 years, smokers demonstrate similar symptom resolution, PPI cessation rates, and satisfaction with surgery as non-smokers. Active smoking does not appear to negatively impact long-term symptomatic outcomes of LARS.
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http://dx.doi.org/10.1007/s00464-020-07956-zDOI Listing
September 2020

An Analysis of Outcomes After Transition From Open to Minimally Invasive Ivor Lewis Esophagectomy.

Ann Thorac Surg 2021 04 1;111(4):1174-1181. Epub 2020 Sep 1.

Division of General and Gastrointestinal Surgery, The Ohio State University Wexner Medical Center, The Ohio State University College of Medicine, Columbus, Ohio.

Background: The morbidity and mortality remain relatively high for transthoracic esophagectomy with open thoracotomy. We compared a total laparoscopic and thoracoscopic minimally invasive Ivor Lewis esophagectomy (M-ILE) cohort with a propensity score-weighted cohort of open Ivor Lewis esophagectomy (O-ILE) cases.

Methods: This is a retrospective review of 259 patients diagnosed with esophageal carcinoma who underwent M-ILE (n = 173) or O-ILE (n = 86) from April 2009 to March 2019. The postoperative morbidity and mortality were reported for each group. Inverse probability of treatment weighting (IPTW) adjustment was used to balance the baseline characteristics between study groups. Recurrence-free and overall survival rates were compared on an intention-to-treat basis.

Results: The IPTW cohort included 249 patients with esophageal carcinoma who underwent M-ILE (n = 163) or O-ILE (n = 86). The overall rate of postoperative adverse events was significantly higher after IPTW adjustment in the O-ILE group (54.2% vs 39.02%; P = .039). The median hospital length of stay was 8.0 (interquartile range, 7.0-9.0) days for the M-ILE group compared with 10.0 (interquartile range, 8.0-14.0) days for the O-ILE group (P < .001). The 3-year overall survival for the M-ILE group was 64.63% (95% confidence interval, 54.7%-72.9%) compared with 54.76% (95% confidence interval, 39.9%-67.4%) for the O-ILE group (P = .447). The 3-year recurrence-free survival rate did not differ significantly between the groups (P = .461).

Conclusions: The M-ILE approach demonstrated short-term clinical outcomes that were superior to O-ILE at our institution. The survival rate and recurrence-free survival rate for M-ILE were not significantly different from O-ILE for esophageal carcinoma.
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http://dx.doi.org/10.1016/j.athoracsur.2020.06.071DOI Listing
April 2021

Perineural invasion predicts for locoregional failure in patients with oesophageal adenocarcinoma treated with neoadjuvant chemoradiotherapy.

J Clin Pathol 2021 Apr 21;74(4):228-233. Epub 2020 Apr 21.

Department of Radiation Oncology, Ohio State University James Cancer Hospital, Columbus, Ohio, USA

Aim: The prognostic significance of perineural invasion (PNI) in oesophageal adenocarcinoma (EAC) is unclear. We examined the association of PNI with clinical outcomes in patients treated with neoadjuvant chemoradiotherapy (nCRT) and surgery.

Methods: We performed a single institutional retrospective study. We evaluated the association of PNI with locoregional recurrence-free survival (LRFS), distant metastasis-free survival, disease-free survival (DFS) and overall survival using log-rank and Cox proportional hazard modelling.

Results: 29 out of 73 patients (40%) had PNI at the time of surgery. The median follow-up was 20.1 months. The median DFS was 18.4 months for patients with PNI vs 41.3 months for patients without PNI (p<0.05). The median LRFS was 23.3 months for patients with PNI and median not reached for patients without PNI (p<0.01). In a multivariate model including age and pathological variables, PNI remained a significant independent predictor of LRFS (HR 0.20, 95% CI 0.07 to 0.60; p=0.004).

Conclusions: For patients with EAC treated with nCRT, PNI found at the time of surgery is significantly associated with worse LRFS. Our data support attempts to validate this finding and perhaps testing the role of adjuvant therapy in patients with PNI.
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http://dx.doi.org/10.1136/jclinpath-2020-206424DOI Listing
April 2021

Octogenarians exhibit quality of life improvement but increased morbidity after paraesophageal hernia repair.

Am J Surg 2020 06 4;219(6):958-962. Epub 2019 Oct 4.

The Ohio State Wexner Medical Center Division of General and Gastrointestinal Surgery, USA.

Background: The benefit of elective laparoscopic paraesophageal hernia repair (eLPEHR) in the elderly is unclear. This study compared quality of life and symptom resolution and morbidity after eLPEHR between octogenarians and younger patients.

Methods: A retrospective review was conducted comparing octogenarians (n = 23) to younger patients (n = 162) undergoing eLPEHR. Primary outcomes were pre and post-operative disease-specific quality of life (GERD-HRQL) and symptom scales (GERSS) and post-operative morbidity and length of stay (LOS).

Results: Octogenarians presented with higher ASA and lower preoperative BMI. Compared to controls, octogenarians exhibited higher overall morbidity (34.8% vs 16.1%, p = 0.03), including cardiac events (8.7% vs 0.6%) and mortality (8.7% vs 0%), and longer LOS (3 vs 2 days, p < 0.005). Post-operative reduction in GERD-HRQL/GERSS scores was comparable between groups.

Conclusion: Octogenarians who undergo eLPEHR exhibit significant improvement in quality of life and symptom burden but may experience increased morbidity, suggesting a role for watchful waiting in this population.

Summary: Symptom burden, quality of life, and immediate post-operative morbidity was compared between octogenarians and younger patients undergoing elective laparoscopic paraesophageal hernia repair at a single institution. While exhibiting comparable post-operative improvement in symptom burden and quality of life, octogenarians experience higher post-operative morbidity. This may suggest a role for watchful waiting in the elderly population.
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http://dx.doi.org/10.1016/j.amjsurg.2019.09.014DOI Listing
June 2020

Laparoscopic Nissen fundoplication improves disease-specific quality of life in patients with gastroesophageal reflux disease and functional gastroesophageal outflow obstruction.

Surg Endosc 2020 06 26;34(6):2608-2612. Epub 2019 Jul 26.

Division of Surgery, The Ohio State University, Columbus, OH, USA.

Introduction: The optimal management of functional esophagogastric junction outflow obstruction (EJOO) remains controversial particularly in the setting of concomitant gastroesophageal reflux disease (GERD). There remains a paucity of data regarding the outcomes of laparoscopic Nissen fundoplication (LNF) in this patient population. We hypothesized that GERD patients with manometric findings of EJOO on preoperative manometry do not have increased rates of postoperative dysphagia compared to those with normal or hypotensive LES pressures.

Materials And Methods: This retrospective cohort study of patients undergoing LNF for GERD compared outcomes in patients with and without functional EJOO (fEJOO). The outcomes of interest included disease-specific quality of life improvement, dysphagia scores, and the need for endoscopic dilation following fundoplication.

Results: Two hundred and eleven patients underwent LNF for GERD and 15 (7.1%) were classified as having fEJOO. Baseline GERD-HRQL [30.0 (21.5-37) vs. 31 (21-37), p = 0.57] were similar between fEJOO and control patients, respectively. There was no difference in baseline dysphagia scores [3.5 (2-5) vs. 2.0 (1-4), p = 0.64] between the two groups. Postoperative GERD-HRQL [5.0 (2-13) vs. 4.0 (1-8), p = 0.59] scores did not differ between fEJOO and control patients at 6-week follow-up. One year after surgery, GERD-HRQL [8.0 (3-9) vs. 4.5 (2-13), p = 0.97] did not differ between groups. Dysphagia rates were similar at 6-week (p = 0.78) and 1-year follow-ups (p = 0.96). The need for dilation at 1 year following fundoplication was similar in both cohorts (13%, p = 0.96).

Conclusion: GERD patients with functional EJOO achieved similar improvements in disease-specific quality of life without increased incidence of dysphagia postoperatively.
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http://dx.doi.org/10.1007/s00464-019-07031-2DOI Listing
June 2020

Esophageal and Esophagogastric Junction Cancers, Version 2.2019, NCCN Clinical Practice Guidelines in Oncology.

J Natl Compr Canc Netw 2019 07;17(7):855-883

National Comprehensive Cancer Network.

Esophageal cancer is the sixth leading cause of cancer-related deaths worldwide. Squamous cell carcinoma is the most common histology in Eastern Europe and Asia, and adenocarcinoma is most common in North America and Western Europe. Surgery is a major component of treatment of locally advanced resectable esophageal and esophagogastric junction (EGJ) cancer, and randomized trials have shown that the addition of preoperative chemoradiation or perioperative chemotherapy to surgery significantly improves survival. Targeted therapies including trastuzumab, ramucirumab, and pembrolizumab have produced encouraging results in the treatment of patients with advanced or metastatic disease. Multidisciplinary team management is essential for all patients with esophageal and EGJ cancers. This selection from the NCCN Guidelines for Esophageal and Esophagogastric Junction Cancers focuses on recommendations for the management of locally advanced and metastatic adenocarcinoma of the esophagus and EGJ.
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http://dx.doi.org/10.6004/jnccn.2019.0033DOI Listing
July 2019

Patterns of hospital utilization after elective minimally invasive foregut surgery.

Surg Endosc 2020 05 12;34(5):2149-2157. Epub 2019 Jul 12.

Division of General and Gastrointestinal Surgery, The Ohio State Wexner Medical Center, N729 Doan Hall, 410 West 10th Avenue, Columbus, OH, 43210, USA.

Introduction: Post-operative non-urgent hospital visits (NUR-HV) are an important quality target for reducing unnecessary healthcare utilization. The primary objective of this study was to characterize 90-day post-operative hospital use and determine independent predictors for NUR-HV and urgent (UR)-HV after elective laparoscopic paraesophageal hernia repair (LPEHR) and Nissen Fundoplication (LNF).

Methods: Five hundred and sixty-two primary LPEHR and LNF patients were retrospectively reviewed at a single institution. Ninety-day NUR-HV and UR-HV were compared to patients without post-operative HV using baseline medical and demographic data, preoperative work-up (manometry, pH testing, disease-specific quality of life and symptom scale scores (GERSS), and hospital course. Multiple logistic models were created using univariate associations (p < 0.1) to model independent predictors of NUR-HV and UR-HV.

Results: NUR-HV accounted for 52% (n = 30) of all 90-HV, while the remaining were UR-HV (n = 28, 48.3%). Compared to controls, NUR-HV were younger (51.2 ± 16.8 years vs. 57.6 ± 15.2, p = 0.05), had a lower baseline BMI (28.2 ± 6.4 vs. 31.3 ± 5.4, p = 0.003) and ASA scores (p = 0.02), presented with higher GERSS (46 (28-60) vs. 35 (19-48), p = 0.02) and dysphagia scores (3 (1-5) vs. 2 (0-4), p = 0.02), were associated with LNF (77.7% vs. 54.6%, p = 0.02), and experienced more post-operative dysphagia (13.3% vs. 4.6%, p = 0.06). UR-HV were older (64.0 ± 13.2 vs. 57.6 ± 15.2, p = 0.03), associated with LPEHR (67.9% vs. 45.4%, p = 0.02), longer hospital stay (2 (1-3) vs. 1 (1-2), p = 0.003), and increased overall (39.3% vs. 15.1%, p = 0.001) and urgent complications (34.6% vs. 8.3%, p < 0.005). Positive predictors of NUR-HV included ASA score < 3 (OR 4.4, p = 0.02), increasing GERSS (1.04, p = 0.01), and reduced peristalsis (OR 4.7, p = 0.01), while UR-HV were independently predicted by urgent complications (5.0, p < 0.00005).

Conclusions: NUR-HV accounted for half of post-operative visits following LNF/LPEHR and were predicted by distinct characteristics compared to UR-HV. This stratification provides novel insight that will guide both preoperative counseling and post-operative quality initiatives.
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http://dx.doi.org/10.1007/s00464-019-06953-1DOI Listing
May 2020

A successful clinical pathway protocol for minimally invasive esophagectomy.

Surg Endosc 2020 04 8;34(4):1696-1703. Epub 2019 Jul 8.

Division of General and Gastrointestinal Surgery, The Ohio State University Wexner Medical Center, N847 Doan Hall, 410 West 10th Avenue, Columbus, OH, 43210, USA.

Background: Minimally invasive esophagectomy is associated with significant morbidity, which can substantially influence the hospital length of stay for patients. Anastomotic leak is the most devastating complication. Minimizing major postoperative complications can facilitate adherence to a clinical pathway protocol and can decrease hospital length of stay.

Methods: This is a retrospective study of 130 patients who underwent an elective laparoscopic and thoracoscopic Ivor Lewis esophagectomy for esophageal carcinoma between August 2014 and June 2018. A total of 112 patients (86%) underwent neoadjuvant chemoradiation. All of the 130 patients underwent a laparoscopic gastric devascularization procedure a median of 15 days prior to the esophagectomy. The target discharge date was postoperative day number 8.

Results: Thirty patients (23.08%) had postoperative complications. Atrial fibrillation (20 patients) [15.38%] was the most frequent complication. Four patients (3.1%) developed an anastomotic leak. There was one postoperative death (0.77%) in the cohort of patients. The median length of stay was 8 days. The mean length of stay for patients without complications was 8 days ± 1.2 days and 12.4 days ± 7.1 days for patients with one or more complications (p = 0.002).

Conclusion: The development of postoperative complications after minimally invasive Ivor Lewis esophagectomy significantly increases hospital length of stay. Performing the operation with a specialized tandem surgical team and including preoperative ischemic preconditioning of the stomach minimizes overall and anastomotic complications and facilitates on time hospital discharge as defined by a perioperative clinical pathway protocol.
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http://dx.doi.org/10.1007/s00464-019-06946-0DOI Listing
April 2020

Total laparoscopic and thoracoscopic Ivor Lewis esophagectomy after neoadjuvant Chemoradiation with minimal overall and anastomotic complications.

J Cardiothorac Surg 2019 Jun 28;14(1):123. Epub 2019 Jun 28.

Division of General and Gastrointestinal Surgery, The Ohio State University Wexner Medical Center, N847 Doan Hall, 410 West 10th Avenue, Columbus, OH, 43210, USA.

Background: The published rates of morbidity and mortality remain relatively high for patients who undergo laparoscopic and thoracoscopic Ivor Lewis esophagectomy. We report the postoperative and oncologic outcomes of a large cohort of patients with esophageal carcinoma who were uniformly treated with laparoscopic and thoracoscopic Ivor Lewis esophagectomy following neoadjuvant chemoradiation.

Methods: This is a retrospective observational study of 112 patients diagnosed with esophageal carcinoma who underwent total laparoscopic and thoracoscopic Ivor Lewis esophagectomy from May 2014 to May 2018. All of the patients received neoadjuvant chemoradiation consisting of 45 to 50.4 Gray of radiation and 3-5 cycles of carboplatin and paclitaxel chemotherapy. Perioperative morbidity and 90-day mortality were recorded. The overall and disease-free survival rates were estimated by Kaplan Meier techniques.

Results: A total of 112 patients completed induction chemoradiation followed by a total laparoscopic and thoracoscopic Ivor Lewis esophagectomy. There were 87 (77.68%) males and 25 (22.32%) females with a mean age of 61.6 years ± 10.4. A total of 28 (25%) patients had one or more complications. A total of 4 patients (3.57%) had an anastomotic leak. The 90-day mortality rate was 0.89%. The 3-year overall survival rate was 64.7% and the 3-year disease-free survival rate was 70.2%.

Conclusion: The current outcomes suggest that laparoscopic and thoracoscopic Ivor Lewis esophagectomy can be performed with minimal overall and anastomotic complications following neoadjuvant chemoradiation.
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http://dx.doi.org/10.1186/s13019-019-0937-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6599249PMC
June 2019

Long-term reported outcomes of transoral incisionless fundoplication: an 8-year cohort study.

Surg Endosc 2019 04 27;33(4):1304-1309. Epub 2018 Aug 27.

Department of Surgery, The Ohio State University, Columbus, OH, USA.

Background: Transoral incisionless fundoplication (TIF) offers an endoscopic approach to the treatment of gastroesophageal reflux disease (GERD). Controlled trials have demonstrated the short-term efficacy of this procedure, but long-term follow-up studies are lacking. The objective of this study was to evaluate the long-term impact of TIF on disease-specific quality of life and antisecretory medication use.

Methods: We performed retrospective cohort study of all patients undergoing TIF between 2007 and 2014 in a large academic medical center. Reflux symptoms and quality of life were assessed using the gastroesophageal reflux disease health-related quality of life (GERD-HRQL) questionnaire at baseline, short-term, and long-term follow-up.

Results: Fifty-seven patients with a median age of 46 (37-59) years and an average BMI of 28.8 ± 4.9 kg/m underwent TIF during the study period. Sixty percent of the patients were female, and all were taking a PPI at least daily. At a median follow-up interval of 97 months, twelve patients had undergone subsequent laparoscopic antireflux surgery (LARS). Of those who had not, 23 had complete long-term follow-up data for analysis and were included in the study. Seventy-three percent reported daily acid-reducing medication use, and the median GERD-HRQL score was 10 (6-14) compared to 24 (15-28) at baseline (p < 0.01). Seventy-eight percent of these patients expressed satisfaction or neutral feelings about their GERD management. There were no significant differences in the baseline characteristics of patients who underwent LARS during the study period and those who did not.

Conclusions: This study demonstrates that TIF can produce durable improvements in disease-specific quality of life in some patients with symptomatic GERD. The majority of patients resumed daily PPI therapy during the study period, but with significantly improved GERD-HRQL scores compared to baseline and increased satisfaction with their medical condition.
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http://dx.doi.org/10.1007/s00464-018-6403-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6461469PMC
April 2019

Re:"Laparoscopic Nissen Fundoplication Controls Symptoms and Improves Disease-Specific Quality of Life in Patients with Class I and II Obesity".

Surgery 2018 11 9;164(5):1126-1134. Epub 2018 Aug 9.

Center for Minimally Invasive Surgery, The Ohio State University Wexner Medical Center, Columbus, OH. Electronic address:

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http://dx.doi.org/10.1016/j.surg.2018.06.035DOI Listing
November 2018

Objective Evidence of Reflux Control After Magnetic Sphincter Augmentation: One Year Results From a Post Approval Study.

Ann Surg 2019 08;270(2):302-308

Department of Surgery, Medical College of Wisconsin, Milwaukee, WI.

Objective: To report 1-year results from a 5-year mandated study.

Summary Background Data: In 2012, the United States Food and Drug Administration approved magnetic sphincter augmentation (MSA) with the LINX Reflux Management System (Torax Medical, Shoreview, MN), a novel device for the surgical treatment of gastroesophageal reflux disease (GERD). Continued assessment of safety and effectiveness has been monitored in a Post Approval Study.

Methods: Multicenter, prospective study of patients with pathologic acid reflux confirmed by esophageal pH testing undergoing MSA. Predefined clinical outcomes were assessed at the annual visit including a validated, disease-specific questionnaire, esophagogastricduodenoscopy and esophageal pH monitoring, and use of proton pump inhibitors.

Results: A total of 200 patients (102 males, 98 females) with a mean age of 48.5 years (range 19.7-71.6) were treated with MSA between March 2013 and August 2015. At 1 year, the mean total acid exposure time decreased from 10.0% at baseline to 3.6%, and 74.4% of patients had normal esophageal acid exposure time (% time pH<4 ≤5.3%). GERD Health-Related Quality of Life scores improved from a median score of 26.0 at baseline to 4.0 at 1 year, with 84% of patients meeting the predefined success criteria of at least a 50% reduction in total GERD Health-Related Quality of Life score compared with baseline. The device removal rate at 1 year was 2.5%. One erosion and no serious adverse events were reported.

Conclusions: Safety and effectiveness of magnetic sphincter augmentation has been demonstrated outside of an investigational setting to further confirm MSA as treatment for GERD.
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http://dx.doi.org/10.1097/SLA.0000000000002789DOI Listing
August 2019

Laparoscopic Nissen fundoplication controls reflux symptoms and improves disease-specific quality of life in patients with class I and II obesity.

Surgery 2017 11 18;162(5):1048-1054. Epub 2017 Aug 18.

Center for Minimally Invasive Surgery, The Ohio State University Wexner Medical Center, Columbus, OH. Electronic address:

Background: Patients with class I obesity and refractory gastroesophageal reflux disease may not qualify for bariatric surgery, and the effectiveness of laparoscopic Nissen fundoplication remains controversial. This study evaluates the early efficacy of laparoscopic Nissen fundoplication in patients with class I and II obesity.

Methods: Data for patients who underwent laparoscopic Nissen fundoplication between 2009 and 2014 were collected prospectively. Cohorts were stratified based on body mass index at the time of surgery: Nonobese (body mass index <30 kg/m), class I obese (body mass index 30-34.9 kg/m), and class II obese (body mass index 35-39.9 kg/m). Primary outcome measures were symptoms assessed using the gastroesophageal reflux symptom scale and the gastroesophageal reflux disease health-related quality of life questionnaires.

Results: One hundred seventy-six patients underwent laparoscopic Nissen fundoplication during the study period: 76 nonobese (body mass index 26.2 ± 2.9 kg/m), 53 class I obese (body mass index 32.4 ± 1.5 kg/m), and 47 class II obese (body mass index 37.7 ± 2.5 kg/m). Baseline gastroesophageal reflux symptom scale scores were 35.5 (6-72), 37.0 (5-72), and 45.0 (5-72) in nonobese, class I obese, and class II obese groups, respectively. Six weeks postoperatively, scores decreased to 6.5 (0-72), 4.0 (0-27), and 9.0 (0-64), respectively (P < .001). After 18-months, scores remained improved at 8.0 (0-72), 5 (0-48), and 4 (0-62), respectively (P < .001). A similar trend was seen in gastroesophageal reflux disease-health-related quality of life scores. Overall, 86%, 83%, and 79% remained free of proton-pump inhibitor medications, respectively.

Conclusion: Laparoscopic Nissen fundoplication provides similar symptom control and quality of life 18-months postoperatively in nonobese and class I and II obese patients. Thus, laparoscopic Nissen fundoplication represents a viable surgical option for patients with class I and II obesity.
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http://dx.doi.org/10.1016/j.surg.2017.07.006DOI Listing
November 2017

Laparoscopic ischemic conditioning of the stomach increases neovascularization of the gastric conduit in patients undergoing esophagectomy for cancer.

J Surg Oncol 2017 Sep 29;116(3):391-397. Epub 2017 May 29.

Division of Gastrointestinal and General Surgery and the Digestive Health Center, Department of Surgery, Oregon Health & Science University Medical Center, Portland, Oregon.

Background And Objectives: Gastric ischemic preconditioning has been proposed to improve blood flow and reduce the incidence of anastomotic complications following esophagectomy with gastric pull-up. This study aimed to evaluate the effect of prolonged ischemic preconditioning on the degree of neovascularization in the distal gastric conduit at the time of esophagectomy.

Methods: A retrospective review of a prospectively maintained database identified 30 patients who underwent esophagectomy. The patients were divided into three groups: control (no preconditioning, n = 9), partial (short gastric vessel ligation only, n = 8), and complete ischemic preconditioning (left and short gastric vessel ligation, n = 13). Microvessel counts were assessed, using immunohistologic analysis to determine the degree of neovascularization at the distal gastric margin.

Results: The groups did not differ in age, gender, BMI, pathologic stage, or cancer subtype. Ischemic preconditioning durations were 163 ± 156 days for partial ischemic preconditioning, compared to 95 ± 50 days for complete ischemic preconditioning (P = 0.2). Immunohistologic analysis demonstrated an increase in microvessel counts of 29% following partial ischemic preconditioning (P = 0.3) and 67% after complete ischemic preconditioning (P < 0.0001), compared to controls.

Conclusions: Our study indicates that prolonged ischemic preconditioning is safe and does not interfere with subsequent esophagectomy. Complete ischemic preconditioning increased neovascularization in the distal gastric conduit.
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http://dx.doi.org/10.1002/jso.24668DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5533617PMC
September 2017

Gastroesophageal reflux after peroral endoscopic myotomy: a multicenter case-control study.

Endoscopy 2017 Jul 4;49(7):634-642. Epub 2017 May 4.

Division of Gastroenterology and Hepatology, Johns Hopkins Hospital, Baltimore, Maryland, United States.

 The variables associated with gastroesophageal reflux (GER) after peroral endoscopic myotomy (POEM) are largely unknown. This study aimed to: 1) identify the prevalence of reflux esophagitis and asymptomatic GER in patients who underwent POEM, and 2) evaluate patient and intraprocedural variables associated with post-POEM GER.  All patients who underwent POEM and subsequent objective testing for GER (pH study with or without upper gastrointestinal [GI] endoscopy) at seven tertiary academic centers (one Asian, two US, four European) were included. Patients were divided into two groups: 1) DeMeester score ≥ 14.72 (cases) and 2) DeMeester score of < 14.72 (controls). Asymptomatic GER was defined as a patient with a DeMeester score ≥ 14.72 who was not consuming proton pump inhibitor (PPI). A total of 282 patients (female 48.2 %, Caucasian 84.8 %; mean body mass index 24.1 kg/m) were included. Clinical success was achieved in 94.3 % of patients. GER evaluation was completed after a median follow-up of 12 months (interquartile range 10 - 24 months). A DeMeester score of ≥ 14.72 was seen in 57.8 % of patients. Multivariable analysis revealed female sex to be the only independent association (odds ratio 1.69, 95 % confidence interval 1.04 - 2.74) with post-POEM GER. No intraprocedural variables were associated with GER. Upper GI endoscopy was available in 233 patients, 54 (23.2 %) of whom were noted to have reflux esophagitis (majority Los Angeles Grade A or B). GER was asymptomatic in 60.1 %.  Post-POEM GER was seen in the majority of patients. No intraprocedural variables were identified to allow for potential alteration in procedural technique.
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http://dx.doi.org/10.1055/s-0043-105485DOI Listing
July 2017

Laparoscopic redo fundoplication improves disease-specific and global quality of life following failed laparoscopic or open fundoplication.

Surg Endosc 2017 11 7;31(11):4649-4655. Epub 2017 Apr 7.

Center for Minimally Invasive Surgery, The Ohio State University Wexner Medical Center, Columbus, OH, USA.

Introduction: Laparoscopic fundoplication is associated with failure rates of up to 30% and redo operation rates of 5-8%. Redo fundoplication improves patient symptoms, but its impact on patient quality of life remains unclear. We hypothesized that laparoscopic redo fundoplication improves disease-specific and global quality of life in patients with recurrent symptoms following failed laparoscopic or open fundoplication.

Methods: Data for all patients undergoing a redo fundoplication between August 2009 and June 2014 were collected prospectively. Reflux symptoms and quality of life were assessed using the Gastroesophageal Reflux Symptom Scale (GERSS), the Gastroesophageal Reflux Disease Health-Related Quality of Life (GERD-HRQL), and the global quality of life Short Form-36 (SF-36) questionnaires obtained at 4 weeks and 16 months post-operatively.

Results: Forty-six patients underwent laparoscopic redo fundoplication during the study period for symptomatic hernia (n = 11), GERD (n = 18), or dysphagia (n = 17). GERSS improved from 41 at baseline to 9 at late follow-up (p < 0.001), and GERD-HRQL scores improved from 30 at baseline to 7 at late follow-up (p < 0.001). Median dysphagia scores decreased from 4.5 to 1 (p = 0.035). SF-36 scores demonstrated a significant improvement in general health (p = 0.016) and emotional well-being (p = 0.036) and a trend toward improved physical function (p = 0.068) in the post-operative period, but these improvements were not statistically significant at longer-term follow-up. Overall, 82% of patients reported satisfaction with their operation, and 96% reported that they would have the operation performed again given the benefit of hindsight.

Conclusions: While associated with long operative times and significant complications, laparoscopic redo fundoplication produces a durable improvement in reflux symptoms and disease-specific quality of life. These procedures also improve global quality of life in the short term and are associated with high patient satisfaction.
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http://dx.doi.org/10.1007/s00464-017-5528-7DOI Listing
November 2017

Advances in the Diagnosis and Treatment of Barrett's Esophagus and Early Esophageal Cancer; Summary of the Kelly and Carlos Pellegrini SSAT/SAGES Luncheon Symposium.

J Gastrointest Surg 2017 08 27;21(8):1342-1349. Epub 2017 Feb 27.

Oregon Health Sciences University, Portland, OR, USA.

Background: Patients with Barrett's esophagus (BE) are at increased risk of developing esophageal adenocarcinoma (EAC). The incidence of EAC is rising faster than any other cancer.

Discussion: Patients with BE have a 30- to 40-fold increased risk of EAC. In the past 20 years, there have been dramatic advances in our understanding of the incidence and natural history of BE. Endoscopic treatment of BE is evolving. Even early EAC has been treated without esophagectomy and good oncologic results in the modern era.
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http://dx.doi.org/10.1007/s11605-017-3390-5DOI Listing
August 2017

Routine staging with endoscopic ultrasound in patients with obstructing esophageal cancer and dysphagia rarely impacts treatment decisions.

Surg Endosc 2017 08 18;31(8):3227-3233. Epub 2016 Nov 18.

Section of Advanced Endoscopy, Division of Gastroenterology, Hepatology and Nutrition, Department of Internal Medicine, The Ohio State University Wexner Medical Center, 410 West 10th Avenue, Columbus, OH, 43210, USA.

Background: Endoscopic ultrasound (EUS) has been routinely utilized for the locoregional staging of esophageal cancer. One important aspect of clinical staging has been to stratify patients to treatment with neoadjuvant chemoradiation or primary surgical therapy. We hypothesized that EUS may have a limited impact on clinical decision making in patients with dysphagia and obstructing esophageal masses.

Methods: This retrospective cohort study included all patients with esophageal adenocarcinoma undergoing esophageal EUS between July 2008 and September 2013. Dysplastic Barrett's esophagus without invasive adenocarcinoma or incomplete staging was excluded. Patient demographics, endoscopic tumor characteristics, the presence of dysphagia, sonographic staging, and post-EUS therapy were recorded. Pathologic staging for patients who underwent primary surgical therapy was also recorded. Locally advanced disease was defined as at least T3 or N1, as these patients are typically treated with neoadjuvant therapy.

Results: Two hundred sixteen patients underwent EUS for esophageal adenocarcinoma, with 147 (68.1%) patients having symptoms of dysphagia on initial presentation. Patients with dysphagia were significantly more likely to have locally advanced disease on EUS than patients without dysphagia (p < 0.0001). Additionally, 145 (67.1%) patients had a partially or completely obstructing mass on initial endoscopy, of which 136 (93.8%) were locally advanced (p < 0.0001 vs. non-obstructing lesions).

Conclusions: An overwhelming majority of patients presenting with dysphagia and/or the presence of at least partially obstructing esophageal mass at the time of esophageal cancer diagnosis had an EUS that demonstrated at least locally advanced disease. The present study supports the hypothesis that EUS may be of limited benefit for management of esophageal cancer in patients with an obstructing mass and dysphagia.
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http://dx.doi.org/10.1007/s00464-016-5351-6DOI Listing
August 2017

Gastric Cancer, Version 3.2016, NCCN Clinical Practice Guidelines in Oncology.

J Natl Compr Canc Netw 2016 10;14(10):1286-1312

Gastric cancer is the fifth most frequently diagnosed cancer and the third leading cause of death from cancer in the world. Several advances have been made in the staging procedures, imaging techniques, and treatment approaches. The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Gastric Cancer provide an evidence- and consensus-based treatment approach for the management of patients with gastric cancer. This manuscript discusses the recommendations outlined in the NCCN Guidelines for staging, assessment of HER2 overexpression, systemic therapy for locally advanced or metastatic disease, and best supportive care for the prevention and management of symptoms due to advanced disease.
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http://dx.doi.org/10.6004/jnccn.2016.0137DOI Listing
October 2016

Preventing anastomotic complications: early results of laparoscopic gastric devascularization two weeks prior to minimally invasive esophagectomy.

Surg Endosc 2017 03 5;31(3):1371-1375. Epub 2016 Aug 5.

Division of General and Gastrointestinal Surgery, Center for Minimally Invasive Surgery, The Ohio State University Wexner Medical Center, 395 W. 12th Avenue, Suite 654, Columbus, OH, 43210, USA.

Background: Laparoscopic gastric devascularization (LGD) is an innovative method to improve gastric conduit perfusion and improve anastomotic healing following esophagectomy. This study reports our early experience with LGD performed two weeks prior to minimally invasive esophagectomy (MIE) with intrathoracic anastomosis.

Methods: We performed a retrospective review of all patients who underwent LGD prior to minimally invasive Ivor Lewis esophagectomy between August 2014 and July 2015 at a large academic medical center. LGD included staging laparoscopy with division of the short gastric vessels, left gastric artery and coronary vein, and posterior gastric attachments. Patient demographics, comorbid conditions, clinical stage, use of neoadjuvant chemoradiation, perioperative events, length of hospital stay, 60-day readmission, and complications were collected and analyzed.

Results: Thirty patients underwent LGD prior to minimally invasive Ivor Lewis esophagectomy, and 21 (70 %) received neoadjuvant chemoradiation. LGD was performed a median of 14.5 (9-42) days prior to esophagectomy. Median operative time was 39 (18-56) minutes, and median length of stay was 0 (0-1) days. There were no complications or readmissions following LGD. MIE was completed laparoscopically in 93 % of patients; two patients required conversion to an open procedure due to mediastinal inflammation following neoadjuvant chemoradiation. Five patients (17 %) were readmitted within 60 days of surgery: one (3 %) patient with an anastomotic leak, two (7 %) with pneumonia, and two (7 %) with post-operative nausea and vomiting. One patient (3 %) expired following an anastomotic leak that required reoperation, and no patients developed an anastomotic stricture during the study period.

Conclusions: LGD with delayed esophageal resection and reconstruction can be safely performed two weeks prior to MIE with minimal morbidity. The low rate of anastomotic leak (3 %) and absence of anastomotic strictures in this series suggest that this approach may successfully improve gastroesophageal anastomotic healing and reduce the rate of anastomotic complications reported with single-stage approaches.
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http://dx.doi.org/10.1007/s00464-016-5122-4DOI Listing
March 2017

Quality-of-life scores in laparoscopic preperitoneal inguinal hernia repair.

Surg Endosc 2016 08 5;30(8):3467-73. Epub 2015 Nov 5.

Department of Surgery, University of Kentucky, Lexington, KY, 40536, USA.

Background: Published support exists for using lightweight polypropylene mesh (PPM) to repair inguinal hernias with increased biocompatibility and decreased foreign body reaction and pain. However, quality of life (QOL) has not been assessed. We assess QOL in patients undergoing laparoscopic totally extraperitoneal hernia repair (TEP) with lightweight PPM.

Methods: We performed an IRB-approved study of patients undergoing TEP hernia repair. Demographic information and hernia characteristics were collected perioperatively. Baseline Short Form-36 (SF-36), Carolinas Comfort Scale (CCS), and visual analog scale (VAS) for pain were performed preoperatively, and then after 1, 26, and 52 weeks.

Results: Forty-eight patients undergoing TEP with mesh were selected. Average age was 43.2 years (SD = 13.2), and average BMI was 26.1 kg/m(2) (SD = 4.3). Procedures include bilateral hernia, right inguinal hernia, and left inguinal hernia repairs. Mean scores on the CCS(®) and VAS were low during the immediate post-op period and 1 year. SF-36 mean scores for body pain, physical function, and role physical showed decreases at the postoperative survey and then subsequent increases. Pain-associated scores increased during the immediate post-op period. CCS and SF-36 scores demonstrated improvement after 1 year. There was no significant difference in VAS. Bilateral repair patients reported more pain and reduced physical function versus unilateral repairs. Patients with larger mesh reported greater pain scores and reduced physical function scores.

Conclusions: Laparoscopic inguinal hernia repair is associated with initial declines in QOL in the postoperative period. Improvements appear in the long term. General health does not appear to be impacted by laparoscopic TEP. Smaller mesh and unilateral repairs are associated with improved QOL following laparoscopic TEP with PPM. Multiple metrics for QOL are required to reflect patient recovery.
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http://dx.doi.org/10.1007/s00464-015-4631-xDOI Listing
August 2016

Prior treatment does not influence the performance or early outcome of per-oral endoscopic myotomy for achalasia.

Surg Endosc 2016 Apr 27;30(4):1282-6. Epub 2015 Jun 27.

Division of General and Gastrointestinal Surgery, The Ohio State University Wexner Medical Center, N729 Doan Hall, 410 W 10th Ave, Columbus, OH, 43210, USA.

Introduction: Per-oral endoscopic myotomy (POEM) is an emerging treatment for achalasia. Pneumatic dilation, botulinum toxin injection, and previous myotomy increase the difficulty of subsequent Heller myotomy, but their impact on POEM remains unknown. The purpose of this study was to compare patients who had undergone prior treatment for their achalasia to those undergoing POEM as an initial therapy.

Methods And Procedures: All patients undergoing POEM were entered into a prospective database from August 2012 to October 2014. Data collected included demographics, dysphagia and symptom survey scores, operative time, clips required for mucosotomy closure, perioperative complications and length of hospital stay.

Results: Forty-five patients underwent POEM during the study period. Fifteen (30%) had undergone previous treatment (seven Botox injection, five pneumatic dilation and three Heller myotomy). Primary POEM patients were younger than those who had had prior treatment (mean age 46 ± 17 vs. 64 ± 12 years, p < 0.001), but gender, body mass index and ASA class were not significantly different. There were no conversions to Heller myotomy or perioperative complications in either group. Operative time for primary POEM was 103 ± 27 versus 102 ± 29 min following prior treatment (p = 0.84). Mucosotomy closure required a median 7 (4-16) and 8 (5-16) clips, respectively (p = 0.08). Length of stay was 1 day in each group. Median dysphagia scores decreased from 4 (0-5) to 1 (0-4) following primary POEM and 4 (0-5) to 0 (0-4) in the prior treatment group (p = 0.45) during a median follow-up of 10 months (5-17 months). All patients in each group expressed satisfaction with their procedure and would undergo the procedure again given the benefit of hindsight.

Conclusion: Per-oral endoscopic myotomy is a safe and effective treatment for achalasia which improves dysphagia and disease-specific quality of life. Previous endoscopic or laparoscopic treatment of achalasia does not affect the performance or early outcome of POEM.
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http://dx.doi.org/10.1007/s00464-015-4339-yDOI Listing
April 2016

Gastroesophageal reflux symptoms do not correlate with objective pH testing after peroral endoscopic myotomy.

Surg Endosc 2016 Mar 27;30(3):947-52. Epub 2015 Jun 27.

Division of General and Gastrointestinal Surgery, The Ohio State University Wexner Medical Center, N729 Doan Hall, 410 W 10th Ave, Columbus, OH, 43210, USA.

Introduction: Peroral endoscopic myotomy (POEM) is an emerging treatment for esophageal achalasia. Postoperative reflux has been found in a significant number of patients, but it is unknown whether subjective reports of reflux correlate with objective pH testing. The purpose of this study was to compare the objective rate of reflux with standardized reflux symptom scales after POEM. Our hypothesis was that subjective symptoms would not correlate with objective measurement of reflux.

Methods And Procedures: Data on all patients undergoing POEM were collected prospectively between August 2012 and June 2014 and included demographics, objective testing (48-h pH probe, manometry, endoscopy), as well as gastroesophageal reflux disease health-related quality of life (GERD-HRQL), GERD symptom scale (GERSS), and antacid use.

Results: Forty-three patients underwent POEM during the study period. The mean age was 53.5 ± 17.4 years with a BMI of 29.6 ± 8.4 kg/m(2), and 27 (63%) were male. Forty-two patients (98%) completed at least 6 months of follow-up, and 26 (60%) underwent repeat pH measurement. Dysphagia scores improved from 4 (0-5) at baseline to 0 (0-3) (p < 0.001). On follow-up pH testing, 11 (42%) were normal and 15 (58%) had elevated DeMeester scores. Postoperative GERSS or GERD-HRQL scores did not correlate with DeMeester scores on Spearman's rank-order tests (r = 0.02, p = 0.93 and r = 0.04, p = 0.50, respectively). Postoperative PPI use was not significantly associated with normal or abnormal pH testing: 5 of 7 (71%) patients who were taking PPIs postoperatively had abnormal DeMeester scores compared to 9 of 18 (50%) of patients who were not taking PPIs (p = 0.332).

Conclusions: Peroral endoscopic myotomy provides excellent dysphagia relief for patients with achalasia, but is associated with a high rate of reflux on pH testing postoperatively. Subjective symptoms are not a reliable indicator of postoperative reflux. Routine pH testing should be considered in all patients following POEM.
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http://dx.doi.org/10.1007/s00464-015-4321-8DOI Listing
March 2016

Long-term Outcomes of Patients Receiving a Magnetic Sphincter Augmentation Device for Gastroesophageal Reflux.

Clin Gastroenterol Hepatol 2016 May 2;14(5):671-7. Epub 2015 Jun 2.

Division of Surgery, Abbott-Northwestern Hospital, Minneapolis, Minnesota.

Background & Aims: Based on results from year 2 of a 5-year trial, in 2012 the US Food and Drug Administration approved the use of a magnetic device to augment lower esophageal sphincter function in patients with gastroesophageal reflux disease (GERD). We report the final results of 5 years of follow-up evaluation of patients who received this device.

Methods: We performed a prospective study of the safety and efficacy of a magnetic device in 100 adults with GERD for 6 months or more, who were partially responsive to daily proton pump inhibitors (PPIs) and had evidence of pathologic esophageal acid exposure, at 14 centers in the United States and The Netherlands. The magnetic device was placed using standard laparoscopic tools and techniques. Eighty-five subjects were followed up for 5 years to evaluate quality of life, reflux control, use of PPIs, and side effects. The GERD-health-related quality of life (GERD-HRQL) questionnaire was administered at baseline to patients on and off PPIs, and after placement of the device; patients served as their own controls. A partial response to PPIs was defined as a GERD-HRQL score of 10 or less on PPIs and a score of 15 or higher off PPIs, or a 6-point or more improvement when scores on vs off PPI were compared.

Results: Over the follow-up period, no device erosions, migrations, or malfunctions occurred. At baseline, the median GERD-HRQL scores were 27 in patients not taking PPIs and 11 in patients on PPIs; 5 years after device placement this score decreased to 4. All patients used PPIs at baseline; this value decreased to 15.3% at 5 years. Moderate or severe regurgitation occurred in 57% of subjects at baseline, but only 1.2% at 5 years. All patients reported the ability to belch and vomit if needed. Bothersome dysphagia was present in 5% at baseline and in 6% at 5 years. Bothersome gas-bloat was present in 52% at baseline and decreased to 8.3% at 5 years.

Conclusions: Augmentation of the lower esophageal sphincter with a magnetic device provides significant and sustained control of reflux, with minimal side effects or complications. No new safety risks emerged over a 5-year follow-up period. These findings validate the long-term safety and efficacy of the magnetic sphincter augmentation device for patients with GERD. ClinicalTrials.gov no: NCT00776997.
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http://dx.doi.org/10.1016/j.cgh.2015.05.028DOI Listing
May 2016

2014 SSAT State-of-the-Art Conference: advances in diagnosis and management of gastroesophageal reflux disease.

J Gastrointest Surg 2015 Mar 18;19(3):458-66. Epub 2014 Dec 18.

Division of General and Gastrointestinal Surgery, The Ohio State University Medical Center, N729 Doan Hall, 410 W. 10th Avenue, Columbus, OH, 43210, USA,

Gastroesophageal reflux disease affects at least 10 % of people in Western societies and produces troublesome symptoms and impairs patients' quality of life. The effective management of GERD is imperative as the diagnosis places a significant cost burden on the United States healthcare system with annual direct cost estimates exceeding 9 billion dollars annually. While effective for many patients, 30-40 % of patients receiving medical therapy with proton pump inhibitors experience troublesome breakthrough symptoms, and recent evidence suggests that this therapy subjects patients to increased risk of complications. Given the high cost of PPI therapy, patients are showing a decrease in willingness to continue with a therapy that provides incomplete relief; however, due to inconsistent outcomes and concern for procedure-related side effects following surgery, only 1 % of the GERD population undergoes anti-reflux surgery annually. The discrepancy between the number of patients who experience suboptimal medical treatment and the number considered for anti-reflux surgery indicates a large therapeutic gap in the management of GERD. The objective of the SSAT State-of-the-Art Conference was to examine technologic advances in the diagnosis and treatment of GERD and to evaluate the ways in which we assess the outcomes of these therapies to provide optimal patient care.
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http://dx.doi.org/10.1007/s11605-014-2724-9DOI Listing
March 2015

Endoscopic mucosal resection for staging and treatment of early esophageal carcinoma: a single institution experience.

Surg Endosc 2015 Aug 4;29(8):2121-5. Epub 2014 Dec 4.

Division of General and Gastrointestinal Surgery, The Ohio State University, Columbus, OH, 43210, USA,

Background: Endoscopic mucosal resection (EMR) has emerged for evaluation and treatment of esophageal nodules. We report our initial experience with EMR for T staging and management of early esophageal cancer.

Methods: We reviewed patients undergoing EMR for esophageal adenocarcinoma between 2008 and 2013. The primary outcome measure was needed for esophagectomy. Secondary outcomes included complete eradication of adenocarcinoma, recurrence or persistence of cancer, nodal status for those undergoing esophagectomy, and complications of endoscopic treatment.

Results: During the study period, 24 patients underwent EMR demonstrating carcinoma, and a grossly margin negative endoscopic resection was achieved in all cases. Ten patients (42 %) had evidence of submucosal invasion and were referred for esophagectomy. Patients with margin negative EMR (n = 10, 42 %) or positive radial margins (n = 4, 16 %) underwent endoscopic surveillance and treatment with radiofrequency ablation or repeat EMR as needed. Thirteen patients (93 %) with intramucosal cancer (IMC) have been successfully managed with ongoing endoscopic surveillance and treatment with a median follow-up of 15.5 months. One patient underwent esophagectomy due to recurrent IMC in the setting of long-segment multifocal high-grade dysplasia. There were no esophageal perforations, one patient developed a self-limited gastrointestinal hemorrhage following EMR, and one had an esophageal stricture following endoscopic management.

Conclusions: IMC can be successfully managed endoscopically and thus esophagectomy is avoided in a significant proportion of patients. Endoscopic management may be utilized in the setting of complete resection or radial margin involvement without evidence of submucosal invasion. Close endoscopic follow-up is of paramount importance even in those with negative margins, because recurrent disease may occur following EMR in these patients.
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http://dx.doi.org/10.1007/s00464-014-3962-3DOI Listing
August 2015

Efficacy of transoral fundoplication vs omeprazole for treatment of regurgitation in a randomized controlled trial.

Gastroenterology 2015 Feb 13;148(2):324-333.e5. Epub 2014 Oct 13.

Department of Surgery, Oregon Health & Science University, Portland, Oregon.

Background & Aims: Transoral esophagogastric fundoplication (TF) can decrease or eliminate features of gastroesophageal reflux disease (GERD) in some patients whose symptoms persist despite proton pump inhibitor (PPI) therapy. We performed a prospective, sham-controlled trial to determine if TF reduced troublesome regurgitation to a greater extent than PPIs in patients with GERD.

Methods: We screened 696 patients with troublesome regurgitation despite daily PPI use with 3 validated GERD-specific symptom scales, on and off PPIs. Those with at least troublesome regurgitation (based on the Montreal definition) on PPIs underwent barium swallow, esophagogastroduodenoscopy, 48-hour esophageal pH monitoring (off PPIs), and high-resolution esophageal manometry analyses. Patients with GERD and hiatal hernias ≤2 cm were randomly assigned to groups that underwent TF and then received 6 months of placebo (n = 87), or sham surgery and 6 months of once- or twice-daily omeprazole (controls, n = 42). Patients were blinded to therapy during follow-up period and reassessed at 2, 12, and 26 weeks. At 6 months, patients underwent 48-hour esophageal pH monitoring and esophagogastroduodenoscopy.

Results: By intention-to-treat analysis, TF eliminated troublesome regurgitation in a larger proportion of patients (67%) than PPIs (45%) (P = .023). A larger proportion of controls had no response at 3 months (36%) than subjects that received TF (11%; P = .004). Control of esophageal pH improved after TF (mean 9.3% before and 6.3% after; P < .001), but not after sham surgery (mean 8.6% before and 8.9% after). Subjects from both groups who completed the protocol had similar reductions in GERD symptom scores. Severe complications were rare (3 subjects receiving TF and 1 receiving the sham surgery).

Conclusions: TF was an effective treatment for patients with GERD symptoms, particularly in those with persistent regurgitation despite PPI therapy, based on evaluation 6 months after the procedure. Clinicaltrials.gov no: NCT01136980.
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http://dx.doi.org/10.1053/j.gastro.2014.10.009DOI Listing
February 2015

Laparoscopic Inguinal Hernia Repair With a Novel Hernia Mesh Incorporating a Nitinol Alloy Frame Compared With a Standard Lightweight Polypropylene Mesh.

Surg Innov 2015 Oct 12;22(5):508-13. Epub 2014 Nov 12.

University of Kentucky, Lexington, KY, USA

Background: Numerous mesh materials are available for laparoscopic inguinal hernia repair. The role of fixation of mesh in laparoscopic inguinal hernia repair remains controversial. Mesh materials have been engineered to anatomically conform to the pelvis to potentially reduce or eliminate the need for fixation. This study evaluates the outcomes of laparoscopic inguinal hernia utilizing a device consisting of a lightweight polypropylene mesh with a nitinol frame (Rebound HRD) compared with repair with lightweight polypropylene mesh with permanent tack fixation.

Methods: A prospective randomized trial evaluating the outcomes of laparoscopic inguinal hernia repair with a lightweight polypropylene mesh with a nitinol frame (N-LWM) compared with standard lightweight polypropylene mesh (LWM) was conducted. Randomization was performed at an N-LWM to LWM ratio of 2:1. Repairs were standardized to a laparoscopic extraperitoneal approach without fixation for N-LWM and titanium tack fixation for LWM repairs. Follow-up assessments were performed at 7 days, 6 months, and 1 year. Outcome measures include visual analog pain scale (VAS), Short Form 36 (SF-36), Carolinas Comfort Scale (CCS), operative details, complications, and recurrences.

Results: There were 47 patients that underwent laparoscopic inguinal hernia repair and adhered to study protocol (31 N-LWM, 16 LWM). The groups did not differ significantly in age, body mass index, ethnicity, or employment. The N-LWM group had bilateral mesh placed in 51.6% and LWM 43.8% (P = .76). Operative duration was similar, 59.6 ± 23.1 minutes for LWM and 62.4 ± 26.7 minutes for N-LWM (P = .705) as was mesh handling time was 5.4 ± 3.1 minutes LWM versus 7.3 ± 3.9 minutes N-LWM (P = .053). VAS, CCS, and SF-36 survey results were similar between groups. There was one recurrence (0.03%) in the N-LWM group.

Conclusions: Nitinol-framed lightweight polypropylene mesh may be safely used during laparoscopic inguinal hernia repair with outcomes comparable to LWM at 1 year. N-LWM does not impact operating room time, mesh handling time, pain, recurrences, or complications.
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http://dx.doi.org/10.1177/1553350614557594DOI Listing
October 2015

Long-term cost-effectiveness of medical, endoscopic and surgical management of gastroesophageal reflux disease.

Surgery 2015 Jan 26;157(1):126-36. Epub 2014 Sep 26.

Department of Surgery, The Ohio State University Wexner Medical Center, Columbus, OH.

Background: The long-term cost effectiveness of medical, endoscopic, and operative treatments for adults with gastroesophageal reflux disease (GERD) remains unclear. We sought to estimate the cost effectiveness of medical, endoscopic, and operative treatments for adults with GERD who require daily proton pump inhibitor (PPI) therapy.

Methods: A Markov model was generated from the payer's perspective using a 6-month cycle and 30-year time horizon. The base-case patient was a 45-year-old man with symptomatic GERD taking 20 mg of omeprazole twice daily. Four treatment strategies were analyzed: PPI therapy, transoral incisionless fundoplication (EsophyX), radiofrequency energy application to the lower esophageal sphincter (Stretta) and laparoscopic Nissen fundoplication. The model parameters were selected using the published literature and institutional billing data. The main outcome measure was the incremental cost-effectiveness ratio (cost per quality-adjusted life-year gained) for each therapy.

Results: In the base case analysis, which assumed a PPI cost of $234 over 6 months ($39 per month), Stretta and laparoscopic Nissen fundoplication were the most cost-effective options over a 30-year time period ($2,470.66 and $5,579.28 per QALY gained, respectively). If the cost of PPI therapy exceeded $90.63 per month over 30 years, laparoscopic Nissen fundoplication became the dominant treatment option. EsophyX was dominated by laparoscopic Nissen fundoplication at all points in time.

Conclusion: Low-cost PPIs, Stretta, and laparoscopic Nissen fundoplication all represent cost-effective treatment strategies. In this model, when PPIs exceed $90 per month, medical therapy is no longer cost effective. Procedural GERD therapy should be considered for patients who require high-dose or expensive PPIs.
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http://dx.doi.org/10.1016/j.surg.2014.05.027DOI Listing
January 2015