Publications by authors named "Vimal K Narula"

24 Publications

  • Page 1 of 1

Clinical spotlight review for the management of choledocholithiasis.

Surg Endosc 2020 04 24;34(4):1482-1491. Epub 2020 Feb 24.

Department of Surgery, Indiana University School of Medicine, 545 Barnhill Drive, EH 130, Indianapolis, IN, 46202, USA.

Choledocholithiasis is a common presentation of symptomatic cholelithiasis that can result in biliary obstruction, cholangitis, and pancreatitis. A systematic English literature search was conducted in PubMed to determine the appropriate management strategies for choledocholithiasis. The following clinical spotlight review is meant to critically review the available evidence and provide recommendations for the work-up, investigations as well as the endoscopic, surgical and percutaneous techniques in the management of choledocholithiasis.
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http://dx.doi.org/10.1007/s00464-020-07462-2DOI Listing
April 2020

Surgeon-performed endoscopic retrograde cholangiopancreatography. Outcomes of 2392 procedures at two tertiary care centers.

Surg Endosc 2018 06 22;32(6):2871-2876. Epub 2017 Dec 22.

Department of Surgery, The Ohio State University/Wexner Medical Center, N729 Doan Hall, 410 West 10th Avenue, Columbus, OH, 43210, USA.

Background: Endoscopic retrograde cholangiopancreatography (ERCP) is a common procedure that, in the United States, is traditionally performed by gastroenterologists. We hypothesized that when performed by well-trained surgeons, ERCP can be performed safely and effectively. The objectives of the study were to assess the rate of successful cannulation of the duct of interest and to assess the 30-day complication and mortality rates.

Methods: We retrospectively reviewed the charts of 1858 patients who underwent 2392 ERCP procedures performed by five surgeons between August 2003 and June 2016 in two centers. Demographic and historical data, indications, procedure-related data and 30-day complication and mortality data were collected and analyzed.

Results: The mean age was 53.4 (range 7-102) years and 1046 (56.3%) were female. 1430 (59.8%) of ERCP procedures involved a surgical endoscopy fellow. The most common indication was suspected or established uncomplicated common bile duct stones (n = 1470, 61.5%), followed by management of an existing biliary or pancreatic stent (n = 370, 15.5%) and acute biliary pancreatitis (n = 173, 7.2%). A therapeutic intervention was performed in 1564 (65.4%), a standard sphincterotomy in 1244 (52.0%), stent placement in 705 (29.5%) and stone removal in 638 (26.7%). When cannulation was attempted, the rate of successful cannulation was 94.1%. When cannulation was attempted during the patient's first ERCP the cannulation rate was 92.4%. 94 complications occurred (5.4%); the most common complication was post-ERCP pancreatitis in 75 (4.2%), significant gastrointestinal bleeding in 7 (0.4%), ascending cholangitis in 11 (0.6%) and perforation in 1 (0.05%). 11 mortalities occurred (0.5%) but none of which were ERCP-related.

Conclusion: When performed by well-trained surgical endoscopists, ERCP is associated with high success rate and acceptable complication rates consistent with previously published reports and in line with societal guidelines.
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http://dx.doi.org/10.1007/s00464-017-5995-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5957783PMC
June 2018

Incidence of abdominal wall metastases following percutaneous endoscopic gastrostomy placement in patients with head and neck cancer.

Surg Endosc 2017 09 30;31(9):3623-3627. Epub 2016 Dec 30.

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

Introduction: Percutaneous endoscopic gastrostomy (PEG) tubes are an effective modality for enteral nutrition in patients with head and neck cancer; however, there have been documented case reports of "seeding" of the abdominal wall by the theoretic risk of dragging the tube along the tumor during PEG placement. The objective of this study is to determine the incidence and contributing risk factors leading to metastasis to the abdominal wall following PEG placement in patients with head and neck cancer.

Methods: A retrospective chart review was performed on patients diagnosed with head and neck malignancy who underwent PEG placement between 1/5/2009 and 12/22/2014. Variables collected included development of abdominal wall metastases, type of malignancy and tumor characteristics, smoking history, PEG placement technique, and survival following recurrence. Data were then analyzed for overall trends.

Results: Out of 777 patients analyzed, a total of five patients with head and neck malignancy were identified with abdominal wall metastasis following PEG tube placement with an overall incidence of 0.64% over an average follow-up of 27.55 months. All of these patients underwent PEG tube insertion via a Pull technique. One patient was found to have a clinically evident and symptomatic stomal metastasis, while the other four patients had radiologically detected metastases either on CT or PET scan. All of the identified patients were found to have stage IV oral cancer at time of initial diagnosis of their head and neck malignancy, followed by widespread distant metastatic disease at time of presentation with their PEG site stomal metastasis.

Conclusion: Abdominal wall metastases following PEG placement are a rare but serious complication in patients with head and neck malignancy.
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http://dx.doi.org/10.1007/s00464-016-5394-8DOI Listing
September 2017

A retrospective comparison of robotic cholecystectomy versus laparoscopic cholecystectomy: operative outcomes and cost analysis.

Surg Endosc 2017 03 5;31(3):1436-1441. 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 Ave, Suite 654, Columbus, OH, 43210, USA.

Introduction: Robotic-assisted surgery is gaining popularity in general surgery. Our objective was to evaluate and compare operative outcomes and total costs for robotic cholecystectomy (RC) and laparoscopic cholecystectomy (LC).

Methods And Procedures: A retrospective review was performed for all patients who underwent single-procedure RC and LC from January 2011 to July 2015 by a single surgeon at a large academic medical center. Demographics, diagnosis, perioperative variables, postoperative complications, 30-day readmissions, and operative and hospital costs were collected and analyzed between those patient groups.

Results: A total of 237 patients underwent RC or LC, and comprised the study population. Ninety-seven patients (40.9 %) underwent LC, and 140 patients (50.1 %) underwent RC. Patients who underwent RC had a higher body mass index (p = 0.03), lower rates of coronary artery disease (p < 0.01), and higher rates of chronic cholecystitis (p < 0.01). There were lower rates of intraoperative cholangiography (p < 0.01) and conversion to an open procedure (p < 0.01), however longer operative times (p < 0.01) for patients in the RC group. There were no bile duct injuries in either group, no difference in bile leak rates (p = 0.65), or need for reoperation (p = 1.000). Cost analysis of outpatient-only procedures, excluding cases with conversion to open or use of intraoperative cholangiography, demonstrated higher total charges (p < 0.01) and cost (p < 0.01) and lower revenue (p < 0.01) for RC compared to LC, with no difference in total payments (p = 0.34).

Conclusions: Robotic cholecystectomy appears to be safe although costlier in comparison with laparoscopic cholecystectomy. Further studies are needed to understand the long-term implications of robotic technology, the cost to the health care system, and its role in minimally invasive surgery.
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http://dx.doi.org/10.1007/s00464-016-5134-0DOI Listing
March 2017

Bioabsorbable hernia plugs in laparoscopic inguinal herniorraphy: short-term and long-term results.

Surg Laparosc Endosc Percutan Tech 2015 Apr;25(2):163-7

Center for Minimally Invasive Surgery, Division of General and Gastrointestinal Surgery, The Ohio State University Wexner Medical Center, Columbus, OH.

Purpose: To report our short-term and long-term experience with laparoscopic inguinal hernia repair (LIHR) using a bioabsorbable plug.

Methods: Patients who underwent LIHR from 2009 to 2011 using a bioabsorbable plug and synthetic mesh patch were reviewed retrospectively. Short-term follow-up information was obtained within 30 days of surgery, whereas long-term follow-up was obtained in 2014. Quality of life was assessed using the Carolinas Comfort Scale.

Results: Forty-four patients (43 male), including 6 (13.6%) with recurrent disease, underwent 52 LIHR with a bioabsorbable plug. Mean age and body mass index were 60.9 ± 10.5 years and 27.9 ± 4.7 kg/m, respectively. Among 39 (88.6%) patients available for short-term follow-up, early postoperative complications were seen in 10 (25.6%) patients, all of which resolved spontaneously. Mean long-term follow-up duration was 41.6 ± 4.1 months, among 30 (68.2%) patients (40 hernia repairs). There were 2 (5%) hernia recurrences, with 1 requiring a reoperation 12 months after initial repair. Only 2 (6.7%) patients reported moderate or bothersome chronic pain.

Conclusions: Bioabsorbable plug combined with a synthetic mesh is safe and effective for use during LIHR. The technique offers an acceptable incidence of chronic pain and recurrence.
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http://dx.doi.org/10.1097/SLE.0000000000000107DOI Listing
April 2015

Near-infrared fluorescent cholangiography facilitates identification of biliary anatomy during laparoscopic cholecystectomy.

Surg Endosc 2015 Feb 2;29(2):368-75. Epub 2014 Jul 2.

Division of General and Gastrointestinal Surgery, Center for Minimally Invasive Surgery, The Ohio State University Wexner Medical Center, 558 Doan Hall, 410 West 10th Avenue, Columbus, OH, 43210, USA.

Background: Intraoperative cholangiography (IOC) is the current gold standard for biliary imaging during laparoscopic cholecystectomy (LC). However, utilization of IOC remains low. Near-infrared fluorescence cholangiography (NIRF-C) is a novel, noninvasive method for real-time, intraoperative biliary mapping. Our aims were to assess the safety and efficacy of NIRF-C for identification of biliary anatomy during LC.

Methods: Patients were administered indocyanine green (ICG) prior to surgery. NIRF-C was used to identify extrahepatic biliary structures before and after partial and complete dissection of Calot's triangle. Routine IOC was performed in each case. Identification of biliary structures using NIRF-C and IOC, and time required to complete each procedure were collected.

Results: Eighty-two patients underwent elective LC with NIRF-C and IOC. Mean age and body mass index (BMI) were 42.6 ± 13.7 years and 31.5 ± 8.2 kg/m(2), respectively. ICG was administered 73.8 ± 26.4 min prior to incision. NIRF-C was significantly faster than IOC (1.9 ± 1.7 vs. 11.8 ± 5.3 min, p < 0.001). IOC was unobtainable in 20 (24.4 %) patients while NIRF-C did not visualize biliary structures in 4 (4.9 %) patients. After complete dissection, the rates of visualization of the cystic duct, common bile duct, and common hepatic duct using NIRF-C were 95.1, 76.8, and 69.5 %, respectively, compared to 72.0, 75.6, and 74.3 % for IOC. In 20 patients where IOC could not be obtained, NIRF-C successfully identified biliary structures in 80 % of the cases. Higher BMI was not a deterrent to visualization of anatomy with NIRF-C. No adverse events were observed with NIRF-C.

Conclusions: NIRF-C is a safe and effective alternative to IOC for imaging extrahepatic biliary structures during LC. This technique should be evaluated further under a variety of acute and chronic gallbladder inflammatory conditions to determine its usefulness in biliary ductal identification.
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http://dx.doi.org/10.1007/s00464-014-3677-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4415528PMC
February 2015

Current national practice patterns for inpatient management of ventral abdominal wall hernia in the United States.

Surg Endosc 2013 Nov 17;27(11):4104-12. Epub 2013 Jul 17.

Department of Surgery, Center for Minimally Invasive Surgery, The Ohio State University Wexner Medical Center, Columbus, OH, 43210, USA,

Background: The health-care burden related to ventral hernia management is substantial, with more than 3 billion dollars in expenditures annually in the US. Previous studies have suggested that the utilization of laparoscopic repair remains relatively low although national volume estimates have not been reported. We sought to estimate the inpatient national volume of elective ventral hernia surgery and characterize the proportion of laparoscopic versus open operations.

Methods: We analyzed data from the Nationwide Inpatient Sample to identify adults with a diagnosis of an umbilical, incisional, or ventral hernia who underwent an elective inpatient repair between 2009 and 2010. Cases that involved other major abdominal or pelvic operations were excluded. Covariates included patient demographics, surgical approach, and use of mesh. National surgical volume estimates were generated and length of stay and total hospital charges were compared for laparoscopic versus open repairs.

Results: A total of 112,070 ventral hernia repairs were included in the analysis: 72.1 % (n = 80,793) were incisional hernia repairs, while umbilical hernia repairs comprised only 6.9 % (n = 7,788). Laparoscopy was utilized in 26.6 % (n = 29,870) of cases. Mesh was placed in 85.8 % (n = 96,265) of cases, including 49.3 % (n = 3,841) of umbilical hernia repairs and 90.1 % (n = 72,973) of incisional hernia repairs. Length of stay and total hospital charges were significantly lower for laparoscopic umbilical, incisional, and "other" ventral hernia repairs (p values all <0.001). Total hospital charges during this 2-year period approached 4 billion dollars ($746 million for laparoscopic repair; $3 billion for open repair).

Conclusions: Utilization of laparoscopy for elective abdominal wall hernia repair remains relatively low in the US despite its excellent outcomes. Given the substantial financial burden associated with these hernias, future research focused on preventing the development and optimizing the surgical treatment of ventral abdominal wall hernias is warranted.
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http://dx.doi.org/10.1007/s00464-013-3075-4DOI Listing
November 2013

Laparoscopic ventral hernia repair: does primary repair in addition to placement of mesh decrease recurrence?

Surg Endosc 2012 May 15;26(5):1264-8. Epub 2011 Nov 15.

Center for Minimally Invasive Surgery, The Ohio State University Medical Center, 747 Doan Hall, 410 W 10th Avenue, Columbus, OH 43210, USA.

Background: The advent of laparoscopic ventral hernia repair (LVHR) not only reduced the morbidity associated with open repair but also led to a decrease in the hernia recurrence rate. However, the rate continues to remain significant.

Methods: A retrospective observational study was conducted on 193 patients who were treated with LVHR by two minimally invasive surgeons in a 24-month period. The patient population was broadly divided into two groups based on the laparoscopic repair of the fascial defect with mesh underlay, or with primary suture repair and mesh underlay (PSR + MU). Patient demographics, rates of hernia recurrence, and other associated complications were compared between the two groups. Patient variables and the clinical outcomes were analyzed with descriptive statistics and chi-square test.

Results: One hundred ninety-three consecutive patients underwent LVHR for incisional (n = 136), umbilical (n = 44), epigastric (n = 9), and parastomal (n = 4) hernia. Hernia recurrence was documented in eight patients (4.1%). The mean follow-up period was 10.5 months (range 1-36 months). Incisional hernias accounted for all eight recurrences. The rate of recurrence in those treated with PSR + MU was 3% (two of 67 cases) in comparison with 4.8% (six of 126 patients) associated with mesh alone. The rate of recurrence in the recurrent hernia group, treated with mesh only, was 10.5% (four of 38 patients) compared with 4.8% (one of 21 patients) in the PSR + MU group.

Conclusions: Primary laparoscopic repair along with mesh placement for the management of ventral hernia was found to be effective in selected cases as evidenced by the low rate of recurrence when compared with conventional laparoscopic repair with mesh alone. Further retrospective and prospective studies, with larger patient enrollment, are warranted to confirm the benefit of this technique over traditional repair.
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http://dx.doi.org/10.1007/s00464-011-2024-3DOI Listing
May 2012

Novel reconstruction of the extrahepatic biliary tree with a biosynthetic absorbable graft.

HPB (Oxford) 2011 Aug 27;13(8):573-8. Epub 2011 Jun 27.

Department of Surgery Department of Pathology, Ohio State University School of Medicine and Public Health, Columbus, OH, USA.

Objectives: The reference standard technique for the reconstruction of the extrahepatic biliary tree is Roux-en-Y hepaticojejunostomy. This procedure is not without complications and may not be feasible in some patients. This project sought to evaluate a novel approach for repairing common bile duct injuries with a biosynthetic graft. This allows for the reconstruction of the anatomy without necessitating an intestinal bypass.

Methods: Study subjects were 11 mongrel hounds. Utilizing an open approach, the common bile duct was transected in each animal. A 1-cm graft of a synthetic bioabsorbable prosthesis was interposed over a 5-Fr pancreatic stent and sewn in place as an interposition tube graft with absorbable sutures. Intraoperative cholangiograms and monthly liver function tests were completed. Animals were killed at 6, 7, 8, 10 and 12 months.

Results: The first five animals were killed early in the process of protocol development. One animal developed obstructive symptoms and was killed on postoperative day 14. The next five animals were longterm survivors without evidence of clinically significant graft stenosis. Mean alkaline phosphatase and total bilirubin were normal, at 140 U/l and 0.2 mg/dl, respectively. Histology showed the complete replacement of the graft with native tissue at 6 months.

Conclusions:   Biliary reconstruction using a synthetic bioabsorbable prosthetic as an interposition tube graft is feasible based on initial results.
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http://dx.doi.org/10.1111/j.1477-2574.2011.00337.xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3163280PMC
August 2011

Laparoscopic Roux-en-Y gastric bypass in patients with body mass index >70 kg/m2.

Surg Obes Relat Dis 2011 Sep-Oct;7(5):587-91. Epub 2011 Mar 12.

Department of Surgery, Division of General and Gastrointestinal Surgery, Center for Minimally Invasive Surgery, Ohio State University Medical Center, Columbus, Ohio 43210, USA.

Background: Sparse published data support the optimal surgical management of megaobesity (body mass index >70 kg/m(2)). The purpose of the present study was to compare laparoscopic Roux-en-Y gastric bypass (LRYGB) and open Roux-en-Y gastric bypass (ORYGB) in megaobese patients.

Methods: We conducted a retrospective review of 89 consecutive patients with a body mass index >70 kg/m(2) who underwent LRYGB or ORYGB from January 2003 to May 2007 at the Ohio State University Medical Center.

Results: LRYGB was performed in 37 patients, with 3 conversions to open surgery, and 52 underwent ORYGB. No statistically significant demographic or preoperative co-morbidity differences were discerned. The mean intraoperative blood loss was lower in the LRYGB group (54 mL versus 211 mL; P < .0001). The median length of stay for both LRYGB and ORYGB groups was 4 days. One patient in the open group died. The postoperative complications were statistically equivalent between the 2 groups. The hernia rate for the LRYGB group was 3% and was 19% in the ORYGB group (P = .02). The patients who underwent LRYGB had greater excess body weight loss at 3 (22.7% versus 17.5%, P = .02) and 6 (37.5% versus 30.5%, P = .03) months. However, the average excess body weight loss at 12 and 24 months was similar (48% and 60%, respectively).

Conclusion: LRYGB is a technically feasible and safe surgical approach in the megaobese. The intraoperative blood loss was less with LRYGB than with ORYGB. The overall mortality and complications were not different, with the exception of hernia frequency, which was significantly greater after ORYGB. The percentage of excess body weight loss at 3 and 6 months was better for the LRYGB group. In both groups of patients, the 12- and 24-month excess body weight loss were similar.
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http://dx.doi.org/10.1016/j.soard.2011.02.010DOI Listing
January 2012

A comparison of outcomes between open and laparoscopic surgical repair of recurrent inguinal hernias.

Surg Endosc 2011 Jul 7;25(7):2330-7. Epub 2011 Feb 7.

Center for Minimally Invasive Surgery, Ohio State University School of Medicine and Public Health, 548 Doan Hall, 410 West 10th Avenue, Columbus, OH 43210-1228, USA.

Background: Inguinal hernia recurrence after surgical repair is a major concern. The authors report their experience with open and laparoscopic repair of recurrent inguinal hernias.

Methods: After institutional review board approval, a retrospective review was performed with the charts of 197 patients who had undergone surgical repair of recurrent inguinal hernias from January 2000 through August 2009, and the data for 172 patients who met the inclusion criteria were analyzed. Surgical variables and clinical outcomes were compared using Student's t test, the Mann-Whitney U test, chi-square, and Fisher's exact test as appropriate.

Results: The review showed that 172 patients had undergone either open mesh repair (n=61) or laparoscopic mesh repair (n=111) for recurrent inguinal hernias. Postoperative complications were experienced by 8 patients in the open group and 17 patients in laparoscopic group (p=0.70). Five patients (8.2%) in the open group and four patients (3.6%) in the laparoscopic group had re-recurrent inguinal hernias (p=0.28). Four patients in the open group (9.5%) and no patients in the laparoscopic group had recurrence during long-term follow-up evaluation (p=0.046). In the laparoscopic group, 76 patients (68.5%) underwent total extraperitoneal (TEP) repair, and 35 patients (31.5%) had transabdominal preperitoneal (TAPP) repair. Postoperative complications were experienced by 13 patients in the TEP group and 4 patients in the TAPP group (p=0.44). Two patients (2.6%) in the TEP group and two patients (5.7%) in the TAPP group had re-recurrent inguinal hernias (p=0.59).

Conclusions: This retrospective review showed no statistical difference in the re-recurrence rate between the two techniques during short-term follow-up evaluation. However, the laparoscopic technique had a significantly lower re-recurrence rate than the open technique during long-term follow-up evaluation. Both procedures were comparable in terms of intra- and postoperative complications. Among laparoscopic techniques, TEP and TAPP repair are acceptable methods for the repair of recurrent inguinal hernia. A multicenter prospective randomized control trial is needed to confirm the findings of this study.
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http://dx.doi.org/10.1007/s00464-010-1564-2DOI Listing
July 2011

A review of 130 humans enrolled in transgastric NOTES protocols at a single institution.

Surg Endosc 2011 Apr 26;25(4):1004-11. Epub 2010 Oct 26.

Division of General Surgery, The Ohio State University School of Medicine and Public Health, 410 West 10th Avenue, Columbus, OH 43210-1228, USA.

Background: The methodology of Natural Orifice Translumenal Endoscopic Surgery (NOTES) has been validated in both human and animal models. Herein is a discussion of our experience gained from the initial 130 patients enrolled in transgastric pre-NOTES and NOTES protocols at our institution.

Methods: A retrospective review of our research database was performed for all patients enrolled in NOTES protocols. The infectious risk of a gastrotomy with and without a NOTES procedure was assessed in 100 patients. Eighty patients completed a true NOTES protocol looking at staging, access, and insufflation with select patients evaluating the potential for bacterial contamination of the abdominal compartment.

Results: A total of 130 patients have completed pre-NOTES and NOTES protocols at our institution. We observed no clinically significant contamination of the abdomen secondary to transgastric procedures in 100 patients. Diagnostic transgastric endoscopic peritoneoscopy (DTEP) was completed in 20 patients with pancreatic head masses and found to have a 95% concordance with laparoscopic exploration for assessment of peritoneal metastases. Blind endoscopic gastrotomy and DTEP were evaluated in 40 patients who underwent laparoscopic Roux-en-Y gastric bypass procedures (LSRYGB) and were found to be safe, reliable, and without a clinically significant risk of contamination. Endoscopic peritoneal insufflation was successfully established and correlated with standard laparoscopic insufflation in 20 patients.

Conclusions: Transgastric NOTES is a safe alternative approach to accessing the peritoneal cavity in humans. The risk of bacterial contamination secondary to peroral and transgastric access is clinically insignificant. A device for the facile closure of the gastric defect is the sole factor limiting institution of this methodology as a standalone technique.
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http://dx.doi.org/10.1007/s00464-010-1369-3DOI Listing
April 2011

Do gastrotomies require repair after endoscopic transgastric peritoneoscopy? A controlled study.

Gastrointest Endosc 2010 May;71(6):1013-7

Center for Minimally Invasive Surgery, Department of Surgery, The Ohio State University, Columbus, Ohio 43210, USA.

Background: The optimal method for closing gastrotomies after transgastric instrumentation has yet to be determined.

Objective: To compare gastrotomy closure with endoscopically delivered bioabsorbable plugs with no closure.

Design: Prospective, controlled study.

Setting: Animal laboratory.

Subjects: Twenty-three dogs undergoing endoscopic transgastric peritoneoscopy between July and August 2007.

Interventions: Endoscopic anterior wall gastrotomies were performed with balloon dilation to allow passage of the endoscope into the peritoneal cavity. The plug group (n = 12) underwent endoscopic placement of a 4 x 6-cm bioabsorbable mesh plug in the perforation, whereas the no-treatment group (n = 11) did not. Animals underwent necropsy 2 weeks after the procedure.

Main Outcome Measurements: Complications related to gastrotomy closure, gastric burst pressures, relationship of burst perforation to gastrotomy, and the degree of adhesions and inflammation at the gastrotomy site.

Results: After the gastrotomy, all dogs survived without any complications. At necropsy, burst pressures were 77 +/- 11 mm Hg and 76 +/- 15 mm Hg (P = .9) in the plug group and no-treatment group, respectively. Perforations occurred at the site of the gastrotomy in 2 of 12 animals in the plug group and in none of the 11 dogs in the no-treatment group (P = .5). Finally, there were minimal adhesions in all dogs (11/11) in the no-treatment group and minimal adhesions in 3 and moderate adhesions or inflammatory masses in 9 of the 12 animals in the plug group (P = .004).

Limitations: Small number of subjects, animal model, no randomization. Gastrotomy trauma during short peritoneoscopy may not be applicable to longer procedures.

Conclusions: After endoscopic gastrotomy, animals that were left untreated did not show any clinical ill effects and demonstrated adequate healing, with fewer adhesions and less inflammation compared with those treated with a bioabsorbable plug.
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http://dx.doi.org/10.1016/j.gie.2010.01.025DOI Listing
May 2010

Safe alternative transgastric peritoneal access in humans: NOTES.

Surgery 2011 Jan 1;149(1):147-52. Epub 2010 Feb 1.

The Ohio State University Medical Center, Department of Surgery, Columbus, OH 43210-1228, USA.

Background: Diagnostic transgastric endoscopic peritoneoscopy has been used to evaluate the abdomen. We present our experience with transgastric endoscopic peritoneoscopy (TEP) to access the peritoneum, direct trocar placement, and perform adhesiolysis without laparoscopic visualization in patients undergoing laparoscopic Roux-en-Y gastric bypass.

Methods: Forty patients participated. There are 2 arms to the study. The initial 20 patients underwent pre-insufflation of the abdomen prior to TEP. The second 20 had no pre-insufflation. Ten patients in each arm had no surgical history. The other 10 had previous intra-abdominal procedures. TEP was performed through a gastrotomy created without laparoscopic visualization. Adhesions were visualized and taken down endoscopically prior to trocar placement. Diagnostic findings, operative times, and clinical course were recorded.

Results: Average TEP time was 19 min. Three patients had limited visualization due to intra-abdominal adhesions (2) and omental fat (1). Three of the 20 without and 17 of 20 with a history of intra-abdominal surgery had adhesions visualized endoscopically. Endoscopic adhesiolysis was performed in 1 and 4 patients in these groups respectively. Six occult umbilical hernias, 1 inguinal hernia, and 1 hiatal hernia were noted on endoscopic exploration. There were no complications related to intubation of the stomach, accessing the peritoneum, or endoscopic exploration.

Conclusion: TEP is a safe and accurate means to access the peritoneum, visualize the abdominal wall, perform adhesiolysis, and direct trocar placement without laparoscopic guidance. Safe and reliable gastric closure remains the sole limitation to its clinical use outside of a protocol necessitating a gastrotomy.
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http://dx.doi.org/10.1016/j.surg.2009.10.060DOI Listing
January 2011

Diagnostic transgastric endoscopic peritoneoscopy: extension of the initial human trial for staging of pancreatic head masses.

Surg Endosc 2010 Jun 7;24(6):1440-6. Epub 2010 Jan 7.

Division of General Surgery, The Ohio State University School of Medicine and Public Health, 410 West 10th Avenue, Columbus, OH 43210-1228, USA.

Background: The validity of natural orifice transluminal endoscopic surgery (NOTES) was confirmed in a human trial of 10 patients undergoing diagnostic transgastric endoscopic peritoneoscopy (DTEP) for staging of pancreatic head masses. This report is an update with 10 additional patients in the series and includes bacterial contamination data.

Methods: The patients in this human trial were scheduled to undergo diagnostic laparoscopy for abdominal staging of a pancreatic head mass. A second surgeon, blinded to the laparoscopic findings, performed a transgastric endoscopic peritoneoscopy (TEP). The findings of laparoscopic exploration were compared with that those of the TEP. Diagnostic findings, operative times, and clinical course were recorded. Bacterial contamination data were collected for the second cohort of 10 patients. Bacterial samples were collected from the scope before use and the abdominal cavity before and after creation of the gastrotomy. Samples were assessed for bacterial counts and species identification. Definitive care was rendered based on the findings from laparoscopy.

Results: In this study, 20 patients underwent diagnostic laparoscopy followed by DTEP. The average time for completion of diagnostic laparoscopy was 10 min compared with 21 min for TEP. The experience acquired during the initial 10 procedures translated to a 7-min decrease in TEP time for the second 10 cases. For 19 of the 20 patients, DTEP corroborated laparoscopic findings for surgical decision making. One endoscopic and five laparoscopic biopsies were performed. Pancreaticoduodenectomy was performed for 14 patients and palliative gastrojejunostomy for 6 patients. No cross-contamination of the peritoneum or infectious complications were noted. No significant complications related to either the endoscopic or laparoscopic approach occurred.

Conclusions: This study supports the authors' previous conclusions that the transgastric approach to diagnostic peritoneoscopy is feasible, safe, and accurate. The lack of documented bacterial contamination further supports the use of this technique. Technical issues, including intraabdominal manipulation and gastric closure, require further investigation.
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http://dx.doi.org/10.1007/s00464-009-0797-4DOI Listing
June 2010

Laparoscopic distal pancreatectomy with splenic conservation: an operation without increased morbidity.

Gastroenterol Res Pract 2009 16;2009:846340. Epub 2009 Dec 16.

Department of Surgery, The Ohio State University Medical Center, Columbus, OH 43210-1228, USA.

Objectives: The advent of minimally invasive techniques was marked by a paradigm shift towards the use of laparoscopy for benign distal pancreatic masses. Herein we describe one center's experience with laparoscopic distal pancreatectomy.

Methods: A retrospective chart review was performed for all distal pancreatectomies completed laparoscopically from 1999 to 2009. Outcomes from those cases completed with a concurrent splenectomy were compared to the spleen-preserving procedures.

Results: Twenty-four patients underwent laparoscopic distal pancreatectomy. Seven had spleen-conserving operations. There was no difference in the mean estimated blood loss (316 versus 285 mL, P = .5) or operative time (179 versus 170 minutes, P = .9). The mean tumor size was not significantly different (3.1 versus 2.2 cm, P = .9). There was no difference in the average hospital stay (7.1 versus 7.0 days, P = .7). Complications in the spleen-preserving group included one iatrogenic colon injury, two pancreatic fistulas, and two cases of iatrogenic diabetes. In the splenectomy group, two developed respiratory failure, three acquired iatrogenic diabetes, and two suffered pancreatic fistulas (71% versus 41%, P = .4).

Conclusions: The laparoscopic distal pancreatectomy is a safe operation with a low morbidity. Splenic conservation does not significantly increase the morbidity of the procedure.
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http://dx.doi.org/10.1155/2009/846340DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2798083PMC
June 2010

Robotic and laparoscopic pancreaticoduodenectomy: a hybrid approach.

Pancreas 2010 Mar;39(2):160-4

Division of General and Gastrointestinal Surgery, Department of Surgery, Center for Minimally Invasive Surgery, The Ohio State University Medical Center, Columbus, OH 43210-1228, USA.

Objectives: Minimally invasive surgery is beneficial for complex operations; robotics may improve performance in these procedures; however, robotic pancreaticoduodenectomy (PD) has been plagued by long operative times. We describe a small series (n = 5) of patients who underwent a hybrid PD for treatment of obstructive jaundice and pancreatic mass.

Methods: After diagnostic laparoscopy, the gallbladder was retracted cephalad and the porta hepatis was dissected. The lesser sac was opened to expose the superior mesenteric vein below the pancreas. Once the vein was cleared, the bile duct, stomach, pancreas, and jejunum were transected. After the uncinate process was cleared, the specimen was removed. The da Vinci S Surgical Robotic System was docked to perform a mucosa-to-mucosa pancreaticojejunostomy and an end-to-side choledochojejunostomy. A stapled gastrojejunostomy and drain placement completed the operation.

Results: Five patients underwent hybrid PD between May 2006 and June 2007. All patients had a history of pancreatitis and presented with obstructive jaundice and a pancreatic mass. The operations were completed with 5 ports. The mean operative time was 7 hours. The mean hospital stay was 9.6 days. At 6 months after the operation, all patients were disease-free.

Conclusions: Complex procedures such as PD can be accomplished with minimally invasive surgical techniques using robotic instrumentation.
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http://dx.doi.org/10.1097/MPA.0b013e3181bd604eDOI Listing
March 2010

Complications related to endoscopic retrograde cholangiopancreatography: a comprehensive clinical review.

J Gastrointestin Liver Dis 2009 Mar;18(1):73-82

Department of Surgery, Div. of Trauma and Surgical Critical Care, Temple University School of Medicine, Philadelphia, PA, USA.

Endoscopic retrograde cholangiopancreatography (ERCP) is one of the most commonly performed endoscopic procedures. It provides the treating physician with both diagnostic and therapeutic options. The recent shift towards interventional uses of ERCP is largely due to the emergence of advanced imaging techniques, including magnetic resonance cholangiopancreatography and ultrasonography. With over 500,000 ERCP procedures performed yearly in the United States alone, it is important that all medical and surgical practitioners be well versed in indications, contraindications, potential complications, benefits, and alternatives to ERCP. The authors present an in-depth review of ERCP-related complications (pancreatitis, bleeding, perforation, etc) as well as special topics related to ERCP (periprocedural antibiotic use, performance of intraoperative ERCP, performance of ERCP during pregnancy, etc).
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March 2009

Transgastric endoscopic peritoneoscopy does not require decontamination of the stomach in humans.

Surg Endosc 2009 Jun 15;23(6):1331-6. Epub 2008 Oct 15.

Division of General & Gastrointestinal Surgery, The Ohio State University School of Medicine and Public Health, Columbus, OH, USA.

Introduction: Natural orifice translumenal endoscopic surgery (NOTES) is a rapidly evolving field that provides endoscopic access to the peritoneum via a natural orifice. One important requirement of this technique is the need to minimize the risk of clinically significant peritoneal contamination. We report the bacterial load and contamination of the peritoneal cavity in ten patients who underwent diagnostic transgastric endoscopic peritoneoscopy.

Methods: Patients participating in this trial were scheduled to undergo diagnostic laparoscopy for evaluation of presumed pancreatic cancer. Findings at diagnostic laparoscopy were compared with those of diagnostic transgastric endoscopic peritoneoscopy, using an orally placed gastroscope, blinding the endoscopist to the laparoscopic findings. We performed no gastric decontamination. Diagnostic findings, operative times, and clinical course were recorded. Gastroscope and peritoneal fluid aspirates were obtained prior to and after the gastrotomy. Each sample was sent for bacterial colony counts, culture, and identification of species.

Results: Ten patients, with an average age of 63.7 years, have completed the protocol. All patients underwent diagnostic laparoscopy followed by successful transgastric access and diagnostic peritoneoscopy. The average time for laparoscopy was 7.2 min, compared with 18 min for transgastric instrumentation. Bacterial sampling was obtained in all ten patients. The average number of colony-forming units (CFU) in the gastroscope aspirate was 132.1 CFU/ml, peritoneal aspirates prior to creation of a gastrotomy showed 160.4 CFU/ml, and peritoneal sampling after gastrotomy had an average of 642.1 CFU/ml. There was no contamination of the peritoneal cavity with species isolated from the gastroscope aspirate. No infectious complications or leaks were noted at 30-day follow-up.

Conclusions: There was no clinically significant contamination of the peritoneal cavity from the gastroscope after transgastric endoscopic instrumentation in humans. Transgastric instrumentation does contaminate the abdominal cavity but, the pathogens do not mount a clinically significant response in terms of either the species or the bacterial load.
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http://dx.doi.org/10.1007/s00464-008-0161-0DOI Listing
June 2009

Transgastric instrumentation and bacterial contamination of the peritoneal cavity.

Surg Endosc 2008 Mar 20;22(3):605-11. Epub 2007 Nov 20.

Division of General Surgery, The Ohio State University School of Medicine and Public Health, 410 West 10th Avenue, Ohio, Columbus, 43210-1228, USA.

Introduction: Natural orifice transluminal endoscopic surgery (NOTES) is a rapidly evolving technique providing access to the peritoneum utilizing an endoscope via a natural orifice. One of the most significant requirements of this technique is the need to minimize the risk of clinically significant peritoneal contamination. We report the bacterial load and contamination of the peritoneal cavity in patients requiring a gastrotomy Roux-en-Y gastric bypass (LSRYGB).

Methods: We prospectively studied 50 patients undergoing a gastrotomy with creation of a gastrojejunostomy during LSRYGB. We recorded the patient's proton-pump inhibitor (PPI) utilization preoperatively and sampled gastric contents without lavage. We also sampled peritoneal fluid prior to and after gastrotomy, noting the length of time the gastrotomy was open to the peritoneum. Each of the three samples was sent for bacterial colony counts, and culture with identification of species.

Results: Fifty patients underwent LSRYGB with a mean operative time of 93 min. The gastrotomy was open to the peritoneal cavity for an average of 18 min. Seventeen of 50 patients were on PPIs preoperatively, resulting in a significant difference in postgastrostomy peritoneal bacterial counts. The average number of colony-forming units (CFU) of the gastric aspirate was 22,303 CFU/ml. Peritoneal aspirates obtained for examination prior to creation of a gastrotomy showed no CFUs in 44 of 50 patients. Peritoneal sampling after gastrotomy showed contamination of the abdomen with an average of 1102 CFU/ml. There was no correlation between the bacterial load in the stomach and peritoneal load after gastrotomy. No infectious complications or leaks developed. One complication of rhabdomyolysis in a patient with no peritoneal bacterial contamination developed.

Conclusions: Transgastric instrumentation does contaminate the abdominal cavity but pathogens are clinically insignificant due to species or bacterial load. Patients on PPIs do have an increased bacterial load in the gastric aspirate, with no clinical significant infection.
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http://dx.doi.org/10.1007/s00464-007-9661-6DOI Listing
March 2008

Gastrotomy closure using bioabsorbable plugs in a canine model.

Surg Endosc 2008 Apr 19;22(4):961-6. Epub 2007 Aug 19.

The Ohio State University, Columbus, OH, USA.

The repair of gastric perforation commonly involves simple suture closure using an open or laparoscopic approach. An endolumenal approach using prosthetic materials may be beneficial. The role of bioprosthetics in this instance has not been thoroughly investigated, thus the authors evaluated the feasibility of gastric perforation repair using a bioabsorbable device and quantified gross and histological changes at the injury site. Twelve canines were anesthetized and underwent open gastrotomy. A 1-cm-diameter perforation was created in the anterior wall of the stomach and plugged with a bioabsorbable device. Intralumenal pH was recorded. Canines were sacrificed at one, four, six, eight, and 12 weeks. The stomach was explanted followed by gross and histological examination. The injury site was examined. The relative ability of the device to seal the perforation was recorded, as were postoperative changes. Tissue samples were analyzed for gross and microscopic tissue growth and compared to normal gastric tissue in the same animal as an internal control. A scoring system of -2 to +2 was used to measure injury site healing (-2= leak, -1= no leak and minimal ingrowth, 0= physiologic healing, +1= mild hypertrophic tissue, +2= severe hypertrophic tissue). In all canines, the bioprosthesis successfully sealed the perforation without leak under ex vivo insufflation. At one week, the device maintained its integrity but there was no tissue ingrowth. Histological healing score was -1. At 4-12 weeks, gross examination revealed a healed injury site in all animals. The lumenal portion of the plug was completely absorbed. The gross and histological healing score ranged from -1 to +1. The application of a bioabsorbable device results in durable closure of gastric perforation with physiologic healing of the injury site. This method of gastrotomy closure may aid in the evolution of advanced endoscopic approaches to perforation closure of hollow viscera.
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http://dx.doi.org/10.1007/s00464-007-9530-3DOI Listing
April 2008

Natural-orifice transgastric endoscopic peritoneoscopy in humans: Initial clinical trial.

Surg Endosc 2008 Jan 14;22(1):16-20. Epub 2007 Aug 14.

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

Background: Natural-orifice translumenal endoscopic surgery (NOTES) is a possible advancement for surgical interventions. We initiated a pilot study in humans to investigate feasibility and develop the techniques and technology necessary for NOTES. Reported herein is the first human clinical trial of NOTES, performing transoral transgastric diagnostic peritoneoscopy.

Methods: Patients were scheduled to undergo diagnostic laparoscopic evaluation of a pancreatic mass. The findings of traditional laparoscopy were recorded by anatomical abdominal quadrant. A second surgeon, blinded to the laparoscopic findings, performed transgastric peritoneoscopy. Diagnostic findings between the two methods were compared and operative times and clinical course were recorded. Definitive care was based on findings at diagnostic laparoscopy.

Results: Ten patients completed the protocol with an average age of 67.6 years. All patients underwent diagnostic laparoscopy followed by successful transgastric access and diagnostic endoscopic peritoneoscopy. The average time of diagnostic laparoscopy was 12.3 minutes compared to 24.8 minutes for the transgastric route. Transgastric abdominal exploration corroborated the decision to proceed to open exploration made during traditional laparoscopic exploration in 9 of 10 patients. Peritoneal or liver biopsies were obtained in four patients by traditional laparoscopy and in one patient by the transgastric access route. Findings were confirmed by laparotomy in nine patients. Eight patients underwent pancreaticoduodenectomy and two underwent palliative gastrojejunostomy and/or hepaticojejunostomy.

Conclusions: Transgastric diagnostic peritoneoscopy is safe and feasible. This study demonstrates the initial steps of NOTES in humans, providing a potential platform for incisionless surgery. Technical issues, including instrumentation, visualization, intra-abdominal manipulation, and gastric closure need further development.
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http://dx.doi.org/10.1007/s00464-007-9548-6DOI Listing
January 2008

A computerized analysis of robotic versus laparoscopic task performance.

Surg Endosc 2007 Dec 24;21(12):2258-61. Epub 2007 May 24.

Center for Minimally Invasive Surgery, The Ohio State University, Columbus, OH 43210, USA.

Introduction: Robotic technology has been postulated to improve performance in advanced surgical skills. We utilized a novel computerized assessment system to objectively describe the technical enhancement in task performance comparing robotic and laparoscopic instrumentation.

Methods And Procedures: Advanced laparoscopic surgeons (2-10 yrs experience) performed three unique task modules using laparoscopic and Telerobotic surgical instrumentation (Intuitive Surgical, Sunnyvale, CA). Performance was evaluated using a computerized assessment system (ProMIS, Dublin, Ireland) and results were recorded as time (s), path (mm) and precision. Each surgeon had an initial training session followed by two testing sessions for each module. A paired Student's t-test was used to analyze the data.

Results: Ten surgeons completed the study. 8/10 surgeons had significant technical enhancement utilizing robotic technology.

Conclusions: The ProMIS computerized assessment system can be modified to objectively obtain task performance data with robotic instrumentation. All the tasks were performed faster and with more precision using the robotic technology than standard laparoscopy.
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http://dx.doi.org/10.1007/s00464-007-9363-0DOI Listing
December 2007