Publications by authors named "Jorge E Marcet"

27 Publications

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Response to: "Proving the Effectiveness of the Fundamentals of Robotic Surgery (FRS) Skills Curriculum: A Single-blinded, Multispecialty, Multi-institutional Randomized Control Trial": Not only surgeon's manual skills..."

Ann Surg 2020 Dec 3. Epub 2020 Dec 3.

Department of Surgery, University of Washington Medical Center, Seattle, WA Department of Surgery, Indiana University School of Medicine, Indianapolis, IN Department of Ob/Gyn, Drexel University College of Medicine, Institute of Surgical Excellence, Philadelphia, PA Florida Hospital Nicholson Center, University of Central Florida College of Medicine, Celebration, FL Department of Surgery, Indiana University School of Medicine, Indianapolis, IN Department of Surgery, St. Mary's Hospital, Imperial College, London, United Kingdom EndoCAS Simulation Center, University of Pisa, Pisa, Italy Andersen Simulation Center, Madigan Army Medical Center, Tacoma, WA Center for Education, Simulation and Innovation, Hartford Hospital, Hartford, CT Penn Medicine Clinical Simulation Center, Philadelphia, PA Department of Colon and Rectal Surgery, Lahey Health and Medical Center, Burlington, MA National and Kapodistrian University of Athens, Athens, Greece Houston Methodist Hospital, Methodist Institute for Technology, Innovation, and Education, Houston, TX USF Health Center for Advanced Medical Learning and Simulation, Tampa, FL Lehigh Valley Health Network, Allentown PA Department of Surgery, Surgical Education and Activities Lab, Duke University Medical Center, Durham, NC Department of Surgery, St. Mary's Hospital, Imperial College, London, United Kingdom Director of Technology Enhanced Learning, ASSERT Centre, College of Medicine and Health, Brookfield Health Sciences Complex, University College Cork, Cork, Ireland.

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http://dx.doi.org/10.1097/SLA.0000000000004658DOI Listing
December 2020

Preoperative intravenous meloxicam for moderate-to-severe pain in the immediate post-operative period: a Phase IIIb randomized clinical trial in 55 patients undergoing primary open or laparoscopic colorectal surgery with bowel resection and/or anastomosis.

Pain Manag 2021 Jan 23;11(1):9-21. Epub 2020 Oct 23.

Baudax Bio Inc., Malvern, PA, 19355, USA.

Evaluate safety/efficacy of intravenous meloxicam in a colorectal enhanced recovery after surgery protocol. Adults undergoing primary open or laparoscopic colorectal surgery with bowel resection and/or anastomosis received meloxicam IV 30 mg (n = 27) or placebo (n = 28) once daily beginning 30 min before surgery. Adverse events: meloxicam IV, 85%; placebo, 93%. Adverse events commonly associated with opioids: 41 versus 61% - including nausea (33 vs 50%), vomiting (19 vs 18%) and ileus (4 vs 18%). Wound healing satisfaction scores (physician-rated), clinical laboratory findings and vital signs were similar in both groups. No anastomotic leaks were reported. Opioid consumption, postoperative pain intensity, length of stay and times to first bowel sound, first flatus and first bowel movement were significantly lower with meloxicam IV versus placebo. Most subjects (>92%) were satisfied with postoperative pain medication. Meloxicam IV was generally well tolerated and associated with decreased opioid consumption, lower resource utilization and functional benefits. NCT03323385 (ClinicalTrials.gov).
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http://dx.doi.org/10.2217/pmt-2020-0061DOI Listing
January 2021

Proving the Effectiveness of the Fundamentals of Robotic Surgery (FRS) Skills Curriculum: A Single-blinded, Multispecialty, Multi-institutional Randomized Control Trial.

Ann Surg 2020 08;272(2):384-392

Technology Enhanced Learning, ASSERT Centre, College of Medicine and Health, Brookfield Health Sciences Complex, University College Cork, Cork, Ireland.

Objective: To demonstrate the noninferiority of the fundamentals of robotic surgery (FRS) skills curriculum over current training paradigms and identify an ideal training platform.

Summary Background Data: There is currently no validated, uniformly accepted curriculum for training in robotic surgery skills.

Methods: Single-blinded parallel-group randomized trial at 12 international American College of Surgeons (ACS) Accredited Education Institutes (AEI). Thirty-three robotic surgery experts and 123 inexperienced surgical trainees were enrolled between April 2015 and November 2016. Benchmarks (proficiency levels) on the 7 FRS Dome tasks were established based on expert performance. Participants were then randomly assigned to 4 training groups: Dome (n = 29), dV-Trainer (n = 30), and DVSS (n = 32) that trained to benchmarks and control (n = 32) that trained using locally available robotic skills curricula. The primary outcome was participant performance after training based on task errors and duration on 5 basic robotic tasks (knot tying, continuous suturing, cutting, dissection, and vessel coagulation) using an avian tissue model (transfer-test). Secondary outcomes included cognitive test scores, GEARS ratings, and robot familiarity checklist scores.

Results: All groups demonstrated significant performance improvement after skills training (P < 0.01). Participating residents and fellows performed tasks faster (DOME and DVSS groups) and with fewer errors than controls (DOME group; P < 0.01). Inter-rater reliability was high for the checklist scores (0.82-0.97) but moderate for GEARS ratings (0.40-0.67).

Conclusions: We provide evidence of effectiveness for the FRS curriculum by demonstrating better performance of those trained following FRS compared with controls on a transfer test. We therefore argue for its implementation across training programs before surgeons apply these skills clinically.
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http://dx.doi.org/10.1097/SLA.0000000000003220DOI Listing
August 2020

A Phase 3, Randomized, Placebo-Controlled Evaluation of the Safety of Intravenous Meloxicam Following Major Surgery.

Clin Pharmacol Drug Dev 2019 11 20;8(8):1062-1072. Epub 2019 Feb 20.

Tampa General Hospital, Tampa, FL, USA.

An intravenous (IV) formulation of meloxicam is being studied for moderate to severe pain management. This phase 3, randomized, multicenter, double-blind, placebo-controlled trial evaluated the safety of once-daily meloxicam IV 30 mg in subjects following major elective surgery. Eligible subjects were randomized (3:1) to receive meloxicam IV 30 mg or placebo administered once daily. Safety was evaluated via adverse events, clinical laboratory tests, vital signs, wound healing, and opioid consumption. The incidence of adverse events was similar between meloxicam IV- and placebo-treated subjects (63.0% versus 65.0%). Investigators assessed most adverse events as mild or moderate in intensity and unrelated to treatment. Adverse events of interest (injection-site reactions, bleeding, cardiovascular, hepatic, renal, thrombotic, and wound-healing events) were similar between groups. Over the treatment period, meloxicam IV was associated with a 23.6% (P = .0531) reduction in total opioid use (9.2 mg morphine equivalent) compared to placebo-treated subjects. The results suggest that meloxicam IV had a safety profile similar to that of placebo with respect to numbers and frequencies of adverse events and reduced opioid consumption in subjects with moderate to severe postoperative pain following major elective surgery.
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http://dx.doi.org/10.1002/cpdd.666DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6899482PMC
November 2019

Consolidation mFOLFOX6 Chemotherapy After Chemoradiotherapy Improves Survival in Patients With Locally Advanced Rectal Cancer: Final Results of a Multicenter Phase II Trial.

Dis Colon Rectum 2018 Oct;61(10):1146-1155

Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.

Background: Adding modified FOLFOX6 (folinic acid, fluorouracil, and oxaliplatin) after chemoradiotherapy and lengthening the chemoradiotherapy-to-surgery interval is associated with an increase in the proportion of rectal cancer patients with a pathological complete response.

Objective: The purpose of this study was to analyze disease-free and overall survival.

Design: This was a nonrandomized phase II trial.

Settings: The study was conducted at multiple institutions.

Patients: Four sequential study groups with stage II or III rectal cancer were included.

Intervention: All of the patients received 50 Gy of radiation with concurrent continuous infusion of fluorouracil for 5 weeks. Patients in each group received 0, 2, 4, or 6 cycles of modified FOLFOX6 after chemoradiation and before total mesorectal excision. Patients were recommended to receive adjuvant chemotherapy after surgery to complete a total of 8 cycles of modified FOLFOX6.

Main Outcome Measures: The trial was powered to detect differences in pathological complete response, which was reported previously. Disease-free and overall survival are the main outcomes for the current study.

Results: Of 259 patients, 211 had a complete follow-up. Median follow-up was 59 months (range, 9-125 mo). The mean number of total chemotherapy cycles differed among the 4 groups (p = 0.002), because one third of patients in the group assigned to no preoperative FOLFOX did not receive any adjuvant chemotherapy. Disease-free survival was significantly associated with study group, ypTNM stage, and pathological complete response (p = 0.004, <0.001, and 0.001). A secondary analysis including only patients who received ≥1 cycle of FOLFOX still showed differences in survival between study groups (p = 0.03).

Limitations: The trial was not randomized and was not powered to show differences in survival. Survival data were not available for 19% of the patients.

Conclusions: Adding modified FOLFOX6 after chemoradiotherapy and before total mesorectal excision increases compliance with systemic chemotherapy and disease-free survival in patients with locally advanced rectal cancer. Neoadjuvant consolidation chemotherapy may have benefits beyond increasing pathological complete response rates. See Video Abstract at http://links.lww.com/DCR/A739.
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http://dx.doi.org/10.1097/DCR.0000000000001207DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6130918PMC
October 2018

Reduction in Central Line-Associated Bloodstream Infections Correlated With the Introduction of a Novel Silver-Plated Dressing for Central Venous Catheters and Maintained for 6 Years.

J Intensive Care Med 2019 Jul 7;34(7):544-549. Epub 2017 Dec 7.

1 Department of Surgery, University of South Florida, Morsani College of Medicine, Tampa, FL, USA.

Objective: To assess a novel silver-plated dressing (SD) for central venous catheters in comparison to chlorhexidine gluconate-impregnated sponge (CHGIS) dressings in preventing central line-associated bloodstream infections (CLABSIs) in adult intensive care unit (ICU) patients.

Design: Retrospective cohort study.

Setting: Tampa General Hospital, an academic medical tertiary care center.

Patients: All adult ICU patients of an academic medical tertiary care center from January 2009 to December 2010.

Measurements And Main Results: A total of 3189 patient records were studied from 7 different ICUs during the 2-year period. Patients received either CHGIS dressings (January 2009-December 2009) or SDs (January 2010-December 2010). Primary outcomes measured were CLABSI rates per 1000 catheter days and ICU length of stay. There were 30 696 catheter days with CHGIS dressings and 31 319 catheter days with SDs. There was a statistically significant decrease in the rate of CLABSI per 1000 catheter days in the SD group, from 2.38 to 1.28 ( P = .001), with an absolute risk reduction of 1.1. There was a significantly lower incidence in the rate of CLABSI per 1000 catheter days in the SD group (incidence rate ratio [IRR] = 0.54, 95% confidence interval [CI]: 0.36-0.80). The relative risk of CLABSI in the SD group was 0.502 (95% CI: 0.340-0.730; P < .001). If SDs are used on all catheters, the decreased rate of CLABSIs observed would calculate to a cost savings of US$4070 to US$39 600 per 1000 catheter days. After successful implementation of the SD, we observed significant reductions in CLABSI rates and a sustained reduction in the subsequent 6 years.

Conclusion: Use of SDs is associated with a significant decrease in CLABSI rates in adult ICU patients compared to CHGIS dressings, with an estimated cost savings of US$4070 to US$39 600 per 1000 catheter days.
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http://dx.doi.org/10.1177/0885066617745034DOI Listing
July 2019

A randomized, double-blind, placebo controlled safety, tolerability, and pharmacokinetic dose escalation study of a gentamicin vancomycin gel in patients undergoing colorectal surgery.

Perioper Med (Lond) 2016 16;5:17. Epub 2016 Jun 16.

Dr. Reddy's Laboratories, Inc., Princeton, NJ USA.

Background: Despite numerous interventions promulgated by the Surgical Care Improve Project (SCIP) and other organizations, surgical site infection (SSI) continues to be a significant medical problem. DFA-02 is a novel bioresorbable modified-release gel consisting of both gentamicin (16.8 mg/mL) and vancomycin (18.8 mg/mL) to be applied during surgical incision closure for the prevention of SSIs. The following double-blind phase 2a trial was designed to test the safety and tolerability of DFA-02.

Methods: At six US sites, the study planned to randomize 40 subjects undergoing colorectal surgery (30 with DFA-02, and eight with placebo gel) in four ascending dose cohorts (10-, 20-, 30-, and 40-mL study drug per wound). Safety was ascertained and serum pharmacokinetics (PK) was determined.

Results: Study enrollment was discontinued after the first three dose cohorts (10, 20, and 30 mL) as even very large incisions could not accommodate more than 20 mL of gel, leaving no scientific justification for the 40-mL cohort. DFA-02 was well tolerated and showed no evidence of local tissue reaction or impairment of wound healing. No serious AEs were deemed related to study drug. Systemic exposure to gentamicin and vancomycin remained well below levels considered to be at higher risk for oto- or nephrotoxicity. The maximal gentamicin and vancomycin levels observed were 2.36 and 0.684 μg/mL at 6 h, which were well below the prespecified stopping criteria of 12 and 20 μg/mL, respectively.

Conclusions: In this small phase 2a study, the study drug was well tolerated and appeared to be free of serious adverse effects. Consistent with these findings, the PK values were consistent with gradual release of the antibiotics from the gel in the surgical site.

Trial Registration: ClinicalTrials.gov, NCT01496352.
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http://dx.doi.org/10.1186/s13741-016-0043-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4910209PMC
June 2016

Organ preservation for clinical T2N0 distal rectal cancer using neoadjuvant chemoradiotherapy and local excision (ACOSOG Z6041): results of an open-label, single-arm, multi-institutional, phase 2 trial.

Lancet Oncol 2015 Nov 22;16(15):1537-1546. Epub 2015 Oct 22.

Brigham and Women's Hospital, Boston, MA, USA.

Background: Local excision is an organ-preserving treatment alternative to transabdominal resection for patients with stage I rectal cancer. However, local excision alone is associated with a high risk of local recurrence and inferior survival compared with transabdominal rectal resection. We investigated the oncological and functional outcomes of neoadjuvant chemoradiotherapy and local excision for patients with stage T2N0 rectal cancer.

Methods: We did a multi-institutional, single-arm, open-label, non-randomised, phase 2 trial of patients with clinically staged T2N0 distal rectal cancer treated with neoadjuvant chemoradiotherapy at 26 American College of Surgeons Oncology Group institutions. Patients with clinical T2N0 rectal adenocarcinoma staged by endorectal ultrasound or endorectal coil MRI, measuring less than 4 cm in greatest diameter, involving less than 40% of the circumference of the rectum, located within 8 cm of the anal verge, and with an Eastern Cooperative Oncology Group performance status of at least 2 were included in the study. Neoadjuvant chemoradiotherapy consisted of capecitabine (original dose 825 mg/m(2) twice daily on days 1-14 and 22-35), oxaliplatin (50 mg/m(2) on weeks 1, 2, 4, and 5), and radiation (5 days a week at 1·8 Gy per day for 5 weeks to a dose of 45 Gy, followed by a boost of 9 Gy, for a total dose of 54 Gy) followed by local excision. Because of adverse events during chemoradiotherapy, the dose of capecitabine was reduced to 725 mg/m(2) twice-daily, 5 days per week, for 5 weeks, and the boost of radiation was reduced to 5·4 Gy, for a total dose of 50·4 Gy. The primary endpoint was 3-year disease-free survival for all eligible patients (intention-to-treat population) and for patients who completed chemotherapy and radiation, and had ypT0, ypT1, or ypT2 tumours, and negative resection margins (per-protocol group). This study is registered with ClinicalTrials.gov, number NCT00114231.

Findings: Between May 25, 2006, and Oct 22, 2009, 79 eligible patients were recruited to the trial and started neoadjuvant chemoradiotherapy. Two patients had no surgery and one had a total mesorectal excision. Four additional patients completed protocol treatment, but one had a positive margin and three had ypT3 tumours. Thus, the per-protocol population consisted of 72 patients. Median follow-up was 56 months (IQR 46-63) for all patients. The estimated 3-year disease-free survival for the intention-to-treat group was 88·2% (95% CI 81·3-95·8), and for the per-protocol group was 86·9% (79·3-95·3). Of 79 eligible patients, 23 (29%) had grade 3 gastrointestinal adverse events, 12 (15%) had grade 3-4 pain, and 12 (15%) had grade 3-4 haematological adverse events during chemoradiation. Of the 77 patients who had surgery, six (8%) had grade 3 pain, three (4%) had grade 3-4 haemorrhage, and three (4%) had gastrointestinal adverse events.

Interpretation: Although the observed 3-year disease free survival was not as high as anticipated, our data suggest that neoadjuvant chemoradiotherapy followed by local excision might be considered as an organ-preserving alternative in carefully selected patients with clinically staged T2N0 tumours who refuse, or are not candidates for, transabdominal resection.

Funding: National Cancer Institute and Sanofi-Aventis.
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http://dx.doi.org/10.1016/S1470-2045(15)00215-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4984260PMC
November 2015

Effect of adding mFOLFOX6 after neoadjuvant chemoradiation in locally advanced rectal cancer: a multicentre, phase 2 trial.

Lancet Oncol 2015 Aug 14;16(8):957-66. Epub 2015 Jul 14.

Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.

Background: Patients with locally advanced rectal cancer who achieve a pathological complete response to neoadjuvant chemoradiation have an improved prognosis. The need for surgery in these patients has been questioned, but the proportion of patients achieving a pathological complete response is small. We aimed to assess whether adding cycles of mFOLFOX6 between chemoradiation and surgery increased the proportion of patients achieving a pathological complete response.

Methods: We did a phase 2, non-randomised trial consisting of four sequential study groups of patients with stage II-III locally advanced rectal cancer at 17 institutions in the USA and Canada. All patients received chemoradiation (fluorouracil 225 mg/m(2) per day by continuous infusion throughout radiotherapy, and 45·0 Gy in 25 fractions, 5 days per week for 5 weeks, followed by a minimum boost of 5·4 Gy). Patients in group 1 had total mesorectal excision 6-8 weeks after chemoradiation. Patients in groups 2-4 received two, four, or six cycles of mFOLFOX6, respectively, between chemoradiation and total mesorectal excision. Each cycle of mFOLFOX6 consisted of racemic leucovorin 200 mg/m(2) or 400 mg/m(2), according to the discretion of the treating investigator, oxaliplatin 85 mg/m(2) in a 2-h infusion, bolus fluorouracil 400 mg/m(2) on day 1, and a 46-h infusion of fluorouracil 2400 mg/m(2). The primary endpoint was the proportion of patients who achieved a pathological complete response, analysed by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00335816.

Findings: Between March 24, 2004, and Nov 16, 2012, 292 patients were registered, 259 of whom (60 in group 1, 67 in group 2, 67 in group 3, and 65 in group 4) met criteria for analysis. 11 (18%, 95% CI 10-30) of 60 patients in group 1, 17 (25%, 16-37) of 67 in group 2, 20 (30%, 19-42) of 67 in group 3, and 25 (38%, 27-51) of 65 in group 4 achieved a pathological complete response (p=0·0036). Study group was independently associated with pathological complete response (group 4 compared with group 1 odds ratio 3·49, 95% CI 1·39-8·75; p=0·011). In group 2, two (3%) of 67 patients had grade 3 adverse events associated with the neoadjuvant administration of mFOLFOX6 and one (1%) had a grade 4 adverse event; in group 3, 12 (18%) of 67 patients had grade 3 adverse events; in group 4, 18 (28%) of 65 patients had grade 3 adverse events and five (8%) had grade 4 adverse events. The most common grade 3 or higher adverse events associated with the neoadjuvant administration of mFOLFOX6 across groups 2-4 were neutropenia (five in group 3 and six in group 4) and lymphopenia (three in group 3 and four in group 4). Across all study groups, 25 grade 3 or worse surgery-related complications occurred (ten in group 1, five in group 2, three in group 3, and seven in group 4); the most common were pelvic abscesses (seven patients) and anastomotic leaks (seven patients).

Interpretation: Delivery of mFOLFOX6 after chemoradiation and before total mesorectal excision has the potential to increase the proportion of patients eligible for less invasive treatment strategies; this strategy is being tested in phase 3 clinical trials.

Funding: National Institutes of Health National Cancer Institute.
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http://dx.doi.org/10.1016/S1470-2045(15)00004-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4670237PMC
August 2015

Do silver-based wound dressings reduce pain? A prospective study and review of the literature.

Burns 2014 Dec;40 Suppl 1:S40-7

University of South Florida, Department of Surgery, Morsani College of Medicine, Tampa, FL, USA.

Silver-containing dressings are a mainstay in the management of burn injury and acute and chronic wounds. In addition to antimicrobial activity, there is anecdotal evidence that silver dressings may modulate or reduce wound pain. Pain is subjective and difficult to quantify, and most studies of silver-containing dressings evaluate pain as a secondary rather than a primary outcome. Nevertheless, a dressing with a proven ability to reduce pain independent of systemic analgesics would have great utility. In this study, we compared patient-reported pain levels in patients previously randomized to receiving silver-nylon dressings vs. conventional gauze dressings in a study of surgical site infection. Compared to gauze dressings, patients in the silver dressing group reported less pain between postoperative days 0 and 9 (p<0.02). Post hoc analysis of analgesic use did not reach statistical significance between the groups. The study was completed with a literature review of the effect of silver on pain. Silver-based dressings may reduce wound pain by providing an occlusive barrier or by other as-yet undefined mechanisms. The role of silver in pain relief, however, cannot be definitively stated until well-designed prospective randomized studies evaluating pain as a primary endpoint are carried out.
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http://dx.doi.org/10.1016/j.burns.2014.09.012DOI Listing
December 2014

Silver-based dressings for the reduction of surgical site infection: review of current experience and recommendation for future studies.

Burns 2014 Dec;40 Suppl 1:S30-9

University of South Florida, Department of Surgery, Morsani College of Medicine, Tampa, FL, USA.

Surgical site infections (SSIs) are the most common hospital acquired infection in surgical patients, occurring in approximately 300,000-500,000 patients a year. SSIs occur across all surgical specialties, but have increased importance in abdominal, colorectal, obstetrical, gynecological, cardiac, vascular, neurological, transplant, and orthopedic procedures where either the inherent risk is elevated or the consequence of an infection would be severe. Current prevention guidelines reduce, but do not completely eliminate, the occurrence of SSIs. We have found the use of silver-nylon wound dressings to significantly reduce the risk SSI associated with colorectal surgery. In this review, we examine the incidence of SSI in high-risk groups, and identify procedures where silver dressings, and other silver products, have been evaluated for the prevention of SSI. Silver-nylon dressings are a useful adjunct in the prevention of SSI in colorectal surgery, neurological surgery, spinal surgery, and certain cardiovascular and orthopedic procedures. Gynecologic, obstetric, breast, transplant, neck, and bariatric procedures, and surgery in obese and diabetic patients, represent other areas where patients are at increased risk of SSI, but in which silver dressings have not been adequately evaluated yet. Recommendation is made for large prospective studies of silver dressings in these populations.
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http://dx.doi.org/10.1016/j.burns.2014.09.011DOI Listing
December 2014

Liposome bupivacaine for improvement in economic outcomes and opioid burden in GI surgery: IMPROVE Study pooled analysis.

J Pain Res 2014 24;7:359-66. Epub 2014 Jun 24.

Department of Anesthesiology, University of Miami Leonard Miller School of Medicine, Miami, FL, USA.

Unlabelled: Postsurgical pain management remains a significant challenge. Liposome bupivacaine, as part of a multimodal analgesic regimen, has been shown to significantly reduce postsurgical opioid consumption, hospital length of stay (LOS), and hospitalization costs in gastrointestinal (GI) surgery, compared with intravenous (IV) opioid-based patient-controlled analgesia (PCA). Pooled results from open-label studies comparing a liposome bupivacaine-based multimodal analgesic regimen with IV opioid PCA were analyzed. Patients (n=191) who underwent planned surgery and received study drug (IV opioid PCA, n=105; multimodal analgesia, n=86) were included. Liposome bupivacaine-based multimodal analgesia compared with IV opioid PCA significantly reduced mean (standard deviation [SD]) postsurgical opioid consumption (38 [55] mg versus [vs] 96 [85] mg; P<0.0001), postsurgical LOS (median 2.9 vs 4.3 days; P<0.0001), and mean hospitalization costs (US$8,271 vs US$10,726; P=0.0109). The multimodal analgesia group reported significantly fewer patients with opioid-related adverse events (AEs) than the IV opioid PCA group (P=0.0027); there were no significant between-group differences in patient satisfaction scores at 30 days. A liposome bupivacaine-based multimodal analgesic regimen was associated with significantly less opioid consumption, opioid-related AEs, and better health economic outcomes compared with an IV opioid PCA-based regimen in patients undergoing GI surgery.

Study Registration: This pooled analysis is based on data from Phase IV clinical trials registered on the US National Institutes of Health www.ClinicalTrials.gov database under study identifiers NCT01460485, NCT01507220, NCT01507233, NCT01509638, NCT01509807, NCT01509820, NCT01461122, NCT01461135, NCT01534988, and NCT01507246.
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http://dx.doi.org/10.2147/JPR.S63764DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4075953PMC
July 2014

Association between surgeon characteristics and their preferences for guideline-concordant staging and treatment for rectal cancer.

Am J Surg 2014 Nov 8;208(5):817-823. Epub 2014 Jun 8.

Division of Gastrointestinal Surgery, Minimally Invasive and Bariatric Surgery, Department of Surgery, University of Iowa College of Medicine, Iowa City, IA, USA.

Background: Rectal cancer guidelines recommend transrectal ultrasound or magnetic resonance imaging for locoregional staging and neoadjuvant chemoradiation therapy (CRT) for Stage II/III disease, but studies show these are underutilized. We examined how surgeon preferences align with guidelines or vary by training.

Methods: Questionnaires on training, years of practice, and staging/treatment preferences were sent to surgeons practicing in Florida.

Results: Of 759 surveys distributed, 321 (42%) responded; 158 were excluded because they were trainees, not treating rectal cancer, or not board certified/eligible. Among the remaining 163, 71% were general surgeons, 18% colorectal surgeons, and 11% surgical oncologists. Colorectal surgeons and surgical oncologists were more likely than general surgeons to prefer transrectal ultrasound/magnetic resonance imaging (79% vs 50%; P < .01), and neoadjuvant CRT (71% vs 45%; P < .01). Differences remained significant after adjusting for years in practice.

Conclusion: Increased focus on appropriate use of staging procedures and neoadjuvant CRT within general surgery training/educational programs is warranted.
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http://dx.doi.org/10.1016/j.amjsurg.2014.03.010DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4267050PMC
November 2014

A reproducible ex vivo model for transanal minimally invasive surgery.

JSLS 2014 Jan-Mar;18(1):62-5

Department of Surgery, Division of Colon and Rectal Surgery, University of South Florida, Tampa, FL, USA.

Background: Rectal tumors can be excised through a number of minimally invasive transanal techniques including transanal excision, transanal endoscopic microsurgery, and transanal minimally invasive surgery (TAMIS). Specialty training is often required to master the nuances of these approaches. This study aimed to create a reproducible transanal excision training model that is suited for laparoendoscopic techniques.

Methods: Frozen porcine rectum and anus with intact perianal skin were commercially obtained. Thawed specimens were then cut to approximately 20 cm in length. The proximal end of the rectum was then everted and suction applied to the mucosa to create pseudopolyps of various sizes (sessile and pedunculated). Larger pedunculated lesions were made by tying the base of the pseudopolyps with 5-0 monofilament sutures to gather more tissue. Methylene blue dye was injected submucosally into the lesions to simulate tattoos. The proximal rectum was then closed with sutures. The model was suspended in a trainer box by clamping the distal end in a ringed clamp and the proximal end to the box. Transanal excisions using TAMIS were then performed. The procedures were done by trained community colorectal surgeons attending courses on transanal minimally invasive surgery.

Results: Both partial- and full-thickness excisions of sessile and pedunculated rectal lesions were successfully performed during simulated TAMIS by trained community surgeons learning this laparoendoscopic technique.

Conclusion: Transanal laparoendoscopic procedures to excise rectal tumors can be successfully and reproducibly performed in an ex vivo porcine anorectal model.
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http://dx.doi.org/10.4293/108680813X13693422518911DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3939344PMC
December 2014

Short-term outcomes of the surgical management of acquired rectourethral fistulas: does technique matter?

Res Rep Urol 2013 30;5:47-51. Epub 2013 Jan 30.

Department of Surgery, College of Medicine, University of South Florida, Tampa, FL, USA.

Background: Acquired rectourethral fistulas are uncommon and challenging to repair. Most arise as a complication of prostate cancer treatment. Several procedures have been described to repair rectourethral fistulas with varying outcomes. We review the etiology, management, and outcomes of patients with rectourethral fistulas at our institution.

Materials And Methods: A retrospective review of patients undergoing repair of rectourethral fistulas was undertaken. Data were collected on patient demographics, fistula etiology, operative procedure, fecal and urinary diversion, and clinical outcome. Patients with urinary and/or fecal diversion underwent radiographic evaluation to confirm closure of the fistula prior to reversal of the diversion.

Results: Fistula repair was performed on 22 patients from 1999 to 2009. All the patients were male of an average age of 69 years (range: 39-82 years). All patients, except one, had prostate cancer. Fistula formation was associated with radiotherapy in 54.4% of patients, brachytherapy in 36.4% of patients, and with external beam radiation therapy in 18.2% of patients. Other causes included prostatectomy (seven patients, 31.8%), cryotherapy (two patients, 9.1%), and perianal abscess (one patient, 4.5%). Procedures performed for fistula repair included transanal repair (eleven patients, 50%), transperineal repair (five patients, 22.7%), transabdominal repair (three patients, 13.6%), and York-Mason repair (three patients, 13.6%). Fourteen patients (63.6%) had urinary diversion. Fecal diversion was performed in 16 (72.7%) patients. Five (22.7%) patients had had previous attempts at fistula repair. Of the 22 patients treated, repair was successful in 20 patients (91%). The average follow-up time was 6 months (range: 3-13 months).

Conclusion: The success rate of treatment of rectourethral fistulas is high, regardless of the procedure type. Patients with previous repair attempts tend to have less favorable outcomes. With high success rates, less invasive procedures should be attempted first.
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http://dx.doi.org/10.2147/RRU.S28002DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3826856PMC
January 2014

Robot-assisted rectopexy and colpopexy for rectal prolapse.

Int Urogynecol J 2014 Apr 30;25(4):553-5. Epub 2013 Nov 30.

Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, University of South Florida, Tampa, FL, USA,

Aim: This video demonstrates a technique for robot-assisted combined rectopexy with colpopexy, but without the use of mesh for rectal prolapse.

Methods: This case features a 61-year-old woman who presents with complaints of tissue protruding through her rectum and fecal incontinence. On examination, she was found to have circumferential, full-thickness rectal prolapse and perineal descent. We present a technique that combines rectopexy with colpopexy without the use of mesh for repair of rectal prolapse. Postoperative examination revealed resolution of rectal prolapse and good perineal support. This video illustrates a technique that may serve as a useful adjunct to have in one's surgical armamentarium in circumstances when mesh should not or cannot be used, such as in cases that require resection of the sigmoid colon or for patients who simply prefer to avoid the use of mesh.

Conclusion: Given that rectal prolapse and posthysterecomy vaginal vault prolapse often occur together, our institution routinely performs colpopexy with rectopexy for rectal prolapse to provide additional support to the pelvic floor as demonstrated in this video.
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http://dx.doi.org/10.1007/s00192-013-2217-5DOI Listing
April 2014

An extended paIn relief trial utilizing the infiltration of a long-acting Multivesicular liPosome foRmulation Of bupiVacaine, EXPAREL (IMPROVE): a Phase IV health economic trial in adult patients undergoing ileostomy reversal.

J Pain Res 2013 18;6:549-55. Epub 2013 Jul 18.

Department of Surgery, Morsani College of Medicine, University of South Florida, Tampa, FL, USA.

Background: Opioid analgesics are effective for postsurgical pain but are associated with opioid-related adverse events, creating a significant clinical and economic burden. Gastrointestinal surgery patients are at high risk for opioid-related adverse events. We conducted a study to assess the impact of an opioid-sparing multimodal analgesia regimen with liposome bupivacaine, compared with the standard of care (intravenous [IV] opioid-based, patient-controlled analgesia [PCA]) on postsurgical opioid use and health economic outcomes in patients undergoing ileostomy reversal.

Methods: In this open-label, multicenter study, sequential cohorts of patients undergoing ileostomy reversal received IV opioid PCA (first cohort); or multimodal analgesia including a single intraoperative administration of liposome bupivacaine (second cohort). Rescue analgesia was available to all patients. Primary outcome measures were postsurgical opioid use, hospital length of stay, and hospitalization costs. Incidence of opioid-related adverse events was also assessed.

Results: Twenty-seven patients were enrolled, underwent the planned surgery, and did not meet any intraoperative exclusion criteria; 16 received liposome bupivacaine-based multimodal analgesia and eleven received the standard IV opioid PCA regimen. The multimodal regimen was associated with significant reductions in opioid use compared with the IV opioid PCA regimen (mean, 20 mg versus 112 mg; median, 6 mg versus 48 mg, respectively; P < 0.01), postsurgical length of stay (median, 3.0 days versus 5.1 days, respectively; P < 0.001), and hospitalization costs (geometric mean, $6482 versus $9282, respectively; P = 0.01).

Conclusion: A liposome bupivacaine-based multimodal analgesic regimen resulted in statistically significant and clinically meaningful reductions in opioid consumption, shorter length of stay, and lower inpatient costs than an IV opioid-based analgesic regimen.
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http://dx.doi.org/10.2147/JPR.S46467DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3720574PMC
July 2013

Treatment of refractory perianal fistulas with ligation of the intersphincteric fistula tract: preliminary results.

Am Surg 2013 Jul;79(7):723-7

Department of Surgery, Division of Colon and Rectal Surgery, University of South Florida, Tampa, Florida 33606, USA.

Several surgical options exist for management of fistula in ano. The goal of treatment is to achieve closure of the fistula while maintaining continence. Sphincter-sparing operations to close perianal fistulas include advancement flap, anal fistula plug, fibrin glue, and fistulectomy. Variable success rates from 30 to 80 per cent have been reported. Ligation of intersphincteric fistula tract (LIFT), first described in 2007, has a reported success rate from 40 to 94 per cent. The objective of this study was to study our results of the LIFT procedure for refractory perianal fistulas. We conducted a retrospective 18-month review of consecutive patients with refractory perianal disease treated with the LIFT procedure at an academic, tertiary, colorectal practice. All patients undergoing a LIFT procedure for anal fistula from August 2010 to August 2012 were included in the study. The primary end points were success rates at 1 month and 3 months. Secondary end points were postoperative complications and maintenance of continence. Twenty patients underwent LIFT procedures of whom nine had previously failed treatments. Mean age was 45 years and included 12 male and eight female patients. Success rate at 1 month was 70 per cent (14 patients) and at 3 months was 80 per cent (16 patients). Success rates for patients with previously failed attempts were 67 per cent at 1 month and 89 per cent at 3 months. Continence was maintained in 100 per cent of patients. Our data support the use of the LIFT procedure for refractory perirectal fistulas.
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July 2013

A large cellular angiofibroma of the male pelvis presenting with obstructive voiding: A case report and review of the literature.

Can Urol Assoc J 2013 May-Jun;7(5-6):E373-5

Department of Urology, University of South Florida, Tampa, FL;

Cellular angiofibromas (CAF) are rare, benign soft-tissue tumours. The diagnosis of CAF is important given the heavy resemblance to other tumours. Herein, we describe a case of a rapidly growing, very large (13.5 cm) CAF located in the deep pelvis of a middle-aged male who presented with difficulty voiding.
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http://dx.doi.org/10.5489/cuaj.1222DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3668395PMC
June 2013

Is it time to lower the recommended screening age for colorectal cancer?

J Am Coll Surg 2011 Sep 7;213(3):352-61. Epub 2011 Jul 7.

Department of Surgery, University of South Florida College of Medicine, Tampa, FL, USA.

Background: Overall, colorectal cancer (CRC) incidence in the US has decreased over the last 30 years, yet it has increased in patients younger than 50. Cancers in this population are more aggressive and advanced at diagnosis. Our goal was to determine if screening should begin at a younger age. To accomplish this, we analyzed the rates of change in CRC incidence, and compared the incidence with that of cervical cancer (CC), which is screened earlier. Locations of CRC were compared to determine the appropriate screening method.

Study Design: Incidence statistics were obtained from the Cancer Query System of the SEER database. Data were obtained from 1987 to 2006 in age groups of 5-year increments from 0 to 4 years old to 85+ years old for incidences of colon, rectal, and overall CRC. Combined data from 2002 to 2006 were queried to determine the locations of tumors and the overall incidence of CRC and CC at different ages.

Results: Across age groups 20 to 49, CRC incidence was higher in 2006 than in 1987. The most significant increase was from age 40 to 44, where CRC increased from a low of 10.7 per 100,000 in 1988 to 17.9 per 100,000 in 2006 (67%). Colon and rectal cancer increased 56% and 94%, respectively. People older than 50 had decreasing incidences. Approximately 30% of cancers in patients aged 35 to 49 occurred proximal to the splenic flexure. The incidence of CRC cancer equaled and subsequently surpassed CC in the 40 to 44 age group.

Conclusions: The most significant increase in CRC has occurred in patients ages 40 to 44. Patients over 50 continued to see a decline. Many of these cancers would be missed with sigmoidoscopy. Consideration should be given for age-based colonoscopic screening beginning at age 40, an age at which the incidence mirrors other accepted screened cancers.
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http://dx.doi.org/10.1016/j.jamcollsurg.2011.04.033DOI Listing
September 2011

The use of silver nylon in preventing surgical site infections following colon and rectal surgery.

Dis Colon Rectum 2011 Aug;54(8):1014-9

Department of Surgery, Division of Colon and Rectal Surgery, University of South Florida, Tampa, Florida, USA.

Background: Patients who undergo colorectal surgery have up to a 30% chance of developing a surgical site infection postoperatively. Silverlon is a silver nylon dressing designed to prevent surgical site infections, but only anecdotal evidence has previously supported its efficacy.

Objective: The aim of this study was to evaluate the effect of silver nylon dressings in patients undergoing colorectal surgery.

Design: We performed a prospective, randomized, controlled trial comparing a silver nylon dressing with gauze dressings in patients undergoing elective colorectal surgery.

Setting: The study was performed at a university-based, tertiary referral center.

Patients: We studied patients undergoing elective colorectal surgery with an abdominal skin incision of at least 3 cm.

Intervention: Patients were randomly assigned to receive either a silver nylon or a gauze dressing.

Main Outcome Measures: The primary end point was surgical site infection occurring within 30 days of surgery.

Results: One hundred ten patients were enrolled in the study and were randomly assigned to 1 of 2 treatment groups. After a 30-day follow-up period, the incidence of surgical site infection was lower in the silver nylon group compared with the control group (13% vs 33%, P = .011). Twenty-five patients in the study developed superficial surgical site infections, 5 in the silver nylon group and 14 in the control group (P = .021). Two patients in the study group developed deep wound infections compared with 4 in the control group (P = .438). Multivariate analysis revealed that patients in the control group had a 3-fold increase in risk of infection compared with patients in the silver nylon group (P = .013).

Limitations: A limitation of this study is that the members of the surgical team were not blinded to the treatment groups.

Conclusion: Silver nylon is safe and effective in preventing surgical site infection following colorectal surgery.
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http://dx.doi.org/10.1097/DCR.0b013e31821c495dDOI Listing
August 2011

Gentamicin-collagen sponge for infection prophylaxis in colorectal surgery.

N Engl J Med 2010 Sep 4;363(11):1038-49. Epub 2010 Aug 4.

Duke Clinical Research Institute, Duke University Medical Center, Durham, NC 27710, USA.

Background: Despite the routine use of prophylactic systemic antibiotics, surgical-site infection continues to be associated with significant morbidity and cost after colorectal surgery. The gentamicin-collagen sponge, an implantable topical antibiotic agent, is approved for surgical implantation in 54 countries. Since 1985, more than 1 million patients have been treated with the sponges.

Methods: In a phase 3 trial, we randomly assigned 602 patients undergoing open or laparoscopically assisted colorectal surgery at 39 U.S. sites to undergo either the insertion of two gentamicin-collagen sponges above the fascia at the time of surgical closure (the sponge group) or no intervention (the control group). All patients received standard care, including prophylactic systemic antibiotics. The primary end point was surgical-site infection occurring within 60 days after surgery, as adjudicated by a clinical-events classification committee that was unaware of the study-group assignments.

Results: The incidence of surgical-site infection was higher in the sponge group (90 of 300 patients [30.0%]) than in the control group (63 of 302 patients [20.9%], P=0.01). Superficial surgical-site infection occurred in 20.3% of patients in the sponge group and 13.6% of patients in the control group (P=0.03), and deep surgical-site infection in 8.3% and 6.0% (P=0.26), respectively. Patients in the sponge group were more likely to visit an emergency room or surgeon's office owing to a wound-related sign or symptom (19.7%, vs. 11.0% in the control group; P=0.004) and to be rehospitalized for surgical-site infection (7.0% vs. 4.3%, P=0.15). The frequency of adverse events did not differ significantly between the two groups.

Conclusions: Our large, multicenter trial shows that the gentamicin-collagen sponge is not effective at preventing surgical-site infection in patients who undergo colorectal surgery; paradoxically, it appears to result in significantly more surgical-site infections. (Funded by Innocoll Technologies; ClinicalTrials.gov number, NCT00600925.)
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http://dx.doi.org/10.1056/NEJMoa1000837DOI Listing
September 2010

Fecal diversion in perirectal fistulizing Crohn's disease is an underutilized and potentially temporary means of successful treatment.

Am Surg 2009 Aug;75(8):715-8

Division of Colon and Rectal Surgery, University of South Florida, Tampa, Florida, USA.

The purpose of this study was to determine the outcome of patients treated with fecal diversion for perirectal fistulizing Crohn's disease. Thirty-nine patients were identified and followed for an average of 60 months. Patients were divided into two groups based on surgical treatment: local surgical treatment only and fecal diversion in addition to local surgical therapy. Thirteen patients (33%) underwent fecal diversion due to the severity of their disease. Eleven of these patients (85%) had complete resolution of their fistulas and only two (15%) required proctectomy. In contrast, only five out of 26 patients (19%) who underwent local surgical procedures alone had complete perirectal disease resolution. Intestinal continuity was restored in six patients (46%) and three of these patients (50%) remained disease free. The remaining three patients had disease recurrence, which required additional local procedures in one patient (17%), but with eventual resolution; the other two patients (33%) necessitated rediversion. Our data suggest that fecal diversion is a viable treatment option for severe perirectal fistulizing Crohn's disease and may be associated with a higher rate of resolution than local surgical treatment alone. In addition, we demonstrate a higher rate of successful intestinal continuity restoration than is typically reported.
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August 2009

Laparoscopic-assisted transvaginal approach for sigmoidectomy and rectocolpopexy.

JSLS 2009 Apr-Jun;13(2):217-20

Division of Colon and Rectal Surgery, University of South Florida, Tampa, Florida, USA.

Background And Objectives: Laparoscopic-assisted colonic resection has been well described for multiple surgical indications. This typically requires an abdominal incision for specimen removal that is associated with the majority of postoperative pain. We describe the first laparoscopic-assisted transvaginal approach for sigmoidectomy and rectocolpopexy for the treatment of rectal prolapse.

Methods: Mobilization of the sigmoid colon was performed laparoscopically using a 12-mm vaginal port and 3 additional 5-mm abdominal ports. A laparoscopic stapler was used through the vaginal port to transect the distal sigmoid colon. The specimen was subsequently externalized through the colpotomy to complete the resection and prepare the remaining bowel for intracorporeal, end-to-end, stapled anastomosis. The colpotomy was then repaired, and the colorectal anastomosis and rectocolpopexy were completed laparoscopically.

Results: Sigmoidectomy and rectocolpopexy were successfully performed laparoscopically by using a transvaginal approach without the need for an abdominal incision for specimen removal. The patient had an uncomplicated postoperative course, complained of minimal pain, and was discharged home on postoperative day 3.

Conclusions: Laparoscopic-assisted transvaginal sigmoidectomy and rectocolpopexy is a feasible option that appears to be associated with little incisional pain and rapid recovery.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3015929PMC
September 2009

Treatment of rectal cancer.

N Engl J Med 2006 Dec;355(23):2487; author reply 2487-8

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December 2006

Flat and polypoid adenocarcinomas of the colorectum: A comparative histomorphologic analysis of 47 cases.

Hum Pathol 2004 May;35(5):604-11

H. Lee Moffitt Cancer Center and Research Institute, University of South Florida, Tampa, FL, USA.

"Flat" colorectal adenomas and adenocarcinomas are well documented in the Japanese literature but only sporadically reported in the English literature. The present study involved systematic morphological analysis of a large series of colorectal carcinomas (CRCs) to determine the frequency of these "flat" CRCs (FCRCs) and analyze their pathological characteristics and associated patient survival. The study group comprised 47 patients (19 females and 28 males) with primary CRC who underwent colorectal resection at the H. Lee Moffitt Cancer Center between 1997 and 2002. These cases were selected based on the gross appearance of the tumors and after review of all of the hematoxylin and eosin-stained tumor sections in a series of 190 consecutive colorectal resections for CRCs. Application of strict morphological criteria classified 22 tumors as FCRCs. For comparison, 25 "polypoid" CRCs (PCRCs) were also identified. Cases of ulcerative fungating annular CRCs and CRCs with mixed gross appearance were excluded from this analysis. Clinicopathologic data, including patient survival, were compared for FCRCS and PCRCs. Statistical analyses were carried out using the chi(2) or Fisher's exact test and log-rank tests. Overall, 22 of 190 CRCs (11%) were found to meet the morphological criteria of FCRCs. Mean patient age was 70.6 years (range, 55 to 87) for FCRCs versus 68.5 years (range, 54 to 91) for PCRCs, and mean tumor size was 4.7 cm (range, 1.6 to 9) for FCRCs versus 4.4 cm (range, 0.5 to 10) for PCRCs. None of the 22 FCRCs and only 1 of 25 (4%) PCRCs were well differentiated; 17 of 22 (77%) FCRCs and 23 of 25 (92%) PCRCs were moderately differentiated; and 5 of 22 (22%) FCRCs and 1 of 25 (4%) PCRCs were poorly differentiated (P = 0.0087). FCRC cases were staged as 0 stage T1, 3 (14%) stage T2, and 19 (86%) stage T3; PCRC cases, as 4 (16%) stage T1, 14 (56%) stage T2, and 7 (28%) stage 3 (P = 0.000031). Similarly, angiolymphatic invasion was identified in 12 of 22 (54%) FCRCs versus 4 of 25 (16%) PCRCs (P = 0.0123). Although some differences between FCRCs and PCRCs were observed on resection in terms of nodal status (N), presence of metastases (M), and perineural invasion, these differences were not statistically significant. In comparison with PCRCs, FCRCs were associated with significantly shorter postresection patient survival at 1 to 5 years (P = 0.028). We have demonstrated in this report that a proportion of primary CRCs resected at our institution were indeed "flat." Furthermore, these FCRCs exhibited higher histological grades, higher T stage, more frequent angiolymphatic invasion, and shorter patient survival compared with PCRCs. Based on these data, FCRC appears to be a worse subtype of colon cancer than PCRC. Further appraisal of FCRCs and additional studies to further elucidate the molecular mechanisms underlying their morphogenesis are warranted.
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http://dx.doi.org/10.1016/j.humpath.2003.11.011DOI Listing
May 2004

Local excision of rectal tumors.

Adv Surg 2002 ;36:259-74

Section of Colon and Rectal Surgery, Department of Surgery, University of South Florida, Tampa, USA.

Local excision of rectal cancer is done with the goal of cure or palliation with minimal morbidity. Careful patient selection is paramount to avoid local recurrence. Endorectal sonography has brought accuracy to the preoperative staging of rectal cancer. Patients with ultrasound stage T1 carcinoma of the distal rectum and well-differentiated or moderately well-differentiated histology can be offered local excision, with expected low morbidity and a low risk of recurrence. Pathologic examination of the entire specimen determines favorable or unfavorable histologic features, and is the basis for final decisions made on therapy. The role of adjuvant therapy after local excision is still being defined. Preoperative chemoradiation followed by local excision appears promising for patients with more advanced or very distal tumors who have a complete pathologic response to the neoadjuvant therapy.
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January 2003