Long-Term, Prospective, Multicenter Study of Poly-4-Hydroxybutyrate Mesh (Phasix Mesh) for Hernia Repair in Cohort at Risk for Complication: 60-Month Follow-Up.

BACKGROUND: Long-term resorbable mesh represents a promising technology for ventral and incisional hernia repair (VIHR). This study evaluates poly-4-hydroxybutyrate mesh (P4HB; Phasix Mesh) among comorbid patients with CDC class I wounds. STUDY DESIGN: This prospective, multi-institutional study evaluated P4HB VIHR in comorbid patients with CDC class I wounds. Primary outcomes included hernia recurrence and surgical site infection. Secondary outcomes included pain, device-related adverse events, quality of life, reoperation, procedure time, and length of stay. Evaluations were scheduled at 1, 3, 6, 12, 18, 24, 30, 36, and 60 months. A time-to-event analysis (Kaplan-Meier) was performed for primary outcomes; secondary outcomes were reported as descriptive statistics. RESULTS: A total of 121 patients (46 male, 75 female) 54.7 ± 12.0 years old with a BMI of 32.2 ± 4.5 kg/m 2 underwent VIHR with P4HB Mesh (mean ± SD). Fifty-four patients (44.6%) completed the 60-month follow-up. Primary outcomes (Kaplan-Meier estimates at 60 months) included recurrence (22.0 ± 4.5%; 95% CI 11.7% to 29.4%) and surgical site infection (10.1 ± 2.8%; 95% CI 3.3 to 14.0). Secondary outcomes included seroma requiring intervention (n = 9), procedure time (167.9 ± 82.5 minutes), length of stay (5.3 ± 5.3 days), reoperation (18 of 121, 14.9%), visual analogue scale-pain (change from baseline -3.16 ± 3.35 cm at 60 months; n = 52), and Carolinas Comfort Total Score (change from baseline -24.3 ± 21.4 at 60 months; n = 52). CONCLUSIONS: Five-year outcomes after VIHR with P4HB mesh were associated with infrequent complications and durable hernia repair outcomes. This study provides a framework for anticipated long-term hernia repair outcomes when using P4HB mesh.

Safety and Efficacy of Bariatric Surgery in Cirrhosis Patients With Extreme Obesity.

OBJECTIVE: To assess the safety and efficacy of bariatric surgery in patients with cirrhosis. SUMMARY BACKGROUND DATA: Bariatric surgery may be a viable option for patients with cirrhosis and extreme obesity. However, the risk of liver decompensation after surgery is not thoroughly investigated. METHODS: We conducted a case-controlled study with 106 obese patients with cirrhosis (cases) and 317 age, sex, body mass index-, and type of surgery-matched obese patients without cirrhosis (controls) who underwent bariatric surgery. RESULTS: Patients with cirrhosis were predominantly Child-Pugh class A (97%) with the diagnosis established prior to surgery in only 46%. In the cirrhosis group, there was no death in the first 30 days compared with 1 patient in the control group. At 90 days there was 1 death in the cirrhosis group but no additional deaths in the control group. In total, 12 months after the surgery, there were 3 deaths in the cirrhosis group and 1 in the control group (2.8% vs 0.6%, P = 0.056). The surgery-related length of stay was significantly longer in patients with cirrhosis (3.7 ±â€Š4.0 vs 2.6 ±â€Š2.4 d, P = 0.001), but the 30-day readmission rate was lower (7.5% vs 11.9%, P = 0.001). The percent of total weight loss at 30 and 90-days was not significantly different between the groups and remained that way even at 1 year (29.1 ±â€Š10.9 vs 31.2 ±â€Š9.4%, P = 0.096). CONCLUSIONS: Bariatric surgery in obese cirrhotic patients is not associated with excessive mortality compared with noncirrhotic obese patients.

High-risk bariatric candidates: does red-flagging predict the post-operative course?

BACKGROUND: Standards for preoperative bariatric patient selection include a thorough psychological evaluation. Using patients "red-flagged" during preoperative evaluations, this study aims to identify trends in long-term follow-up and complications to further optimize bariatric patient selection. METHODS: A multidisciplinary team held a case review conference (CRC) to discuss red-flagged patients. A retrospective chart review compared CRC patients to control patients who underwent bariatric surgery in the same interval. Patients under 18 years old, undergoing revisional bariatric surgery, or getting band placement were excluded. High-risk characteristics causing CRC inclusion, preoperative demographics, percent follow-up and other postoperative outcomes were collected up to 5 years postoperatively. If univariate analysis revealed a significant difference between cohorts, multivariable analysis was performed. RESULTS: Two hundred and fifty three patients were red-flagged from 2012 to 2013, of which 79 underwent surgery. After excluding 21 revisions, 3 non-adult patients, and 6 band patients, 55 red-flagged patients were analyzed in addition to 273 control patients. Patient age, sex, initial BMI, ASA, and co-morbidities were similar between groups, though flagged patients underwent RYGB more frequently than control patients. Notably, percent excess BMI loss and percent follow-up (6 months-5 years) were similar. In multivariable analysis, minor complications were more common in flagged patients; and marginal ulcers, endoscopy, and dilation for stenosis were more common in flagged versus control patients who underwent RYGB. Perforation, reoperation, revision, incisional hernia, and internal hernia were statistically similar in both groups, though reoperation was significantly more common in patients with multiple reasons to be flagged compared to controls. CONCLUSION: Bariatric patients deemed high risk for various psychosocial issues have similar follow-up, BMI loss, and major complications compared to controls. High-risk RYGB patients have greater minor complications, warranting additional counseling of high-risk patients.

Assessment of Chief Resident Practice Readiness in a Porcine Lab: A 4-Year Experience.

OBJECTIVE: General surgery training prepares residents for the autonomous practice of surgery; however, assessment for readiness for independent practice presents several challenges. The simulation lab offers a safe and standardized environment for assessing the technical skills of a resident in the absence of numerous confounders of the real operating room. We describe our experience with evaluation and remediation of chief resident assessments in a porcine simulation lab. DESIGN: Operative skill assessment of surgical residents was conducted using anesthetized porcine models. Procedure's representative of basic and complex operative skill was chosen for the assessment. Faculty assessed the residents using a checklist for the completion of all critical operative steps. A "failing" score or "critical fail" on a given procedure determined mandatory remediation. For remediation, faculty provided immediate post-procedure feedback on all errors, and residents were offered supervised practice. Residents were then retested to demonstrate competency. SETTING: Large animal research center at Indiana University School of Medicine, Indianapolis, IN PARTICIPANTS: From 2017 to 2020, thirty-seven PGY5 residents participated in the porcine lab over a 4-year period. These general surgery residents were assessed at the beginning of their chief year. RESULTS: There were a total of 6 residents that failed 1 or more procedures. There were no failures in the cholecystectomy, 3 failures for Nissen, 4 failures for Hand sewn anastomosis, and 1 failure for stapled anastomosis. Two residents failed 2 procedures. All residents received remediation with a faculty member and were subsequently able to perform the procedure competently. CONCLUSIONS: A formal simulation-based assessment of procedural competence can identify technical performance deficiencies even at the chief resident level. Combined with a formal remediation program, such deficiencies can be addressed well in advance of residency graduation. Determining the relationship of such simulation-based assessments with operative performance is currently underway.

Prospective, multicenter study of P4HB (Phasix™) mesh for hernia repair in cohort at risk for complications: 3-Year follow-up.

BACKGROUND: This study represents a prospective, multicenter, open-label study to assess the safety, performance, and outcomes of poly-4-hydroxybutyrate (P4HB, Phasix™) mesh for primary ventral, primary incisional, or multiply-recurrent hernia in subjects at risk for complications. This study reports 3-year clinical outcomes. MATERIALS AND METHODS: P4HB mesh was implanted in 121 patients via retrorectus or onlay technique. Physical exam and/or quality of life surveys were completed at 1, 3, 6,12, 18, 24, and 36 months, with 5-year (60-month) follow-up ongoing. RESULTS: A total of n = 121 patients were implanted with P4HB mesh (n = 75 (62%) female) with a mean age of 54.7 ± 12.0 years and mean BMI of 32.2 ± 4.5 kg/m2 (±standard deviation). Comorbidities included: obesity (78.5%), active smokers (23.1%), COPD (28.1%), diabetes mellitus (33.1%), immunosuppression (8.3%), coronary artery disease (21.5%), chronic corticosteroid use (5.0%), hypo-albuminemia (2.5%), advanced age (5.0%), and renal insufficiency (0.8%). Hernias were repaired via retrorectus (n = 45, 37.2% with myofascial release (MR) or n = 43, 35.5% without MR), onlay (n = 8, 6.6% with MR or n = 24, 19.8% without MR), or not reported (n = 1, 0.8%). 82 patients (67.8%) completed 36-month follow-up. 17 patients (17.9% ± 0.4%) experienced hernia recurrence at 3 years, with n = 9 in the retrorectus group and n = 8 in the onlay group. SSI (n = 11) occurred in 9.3% ± 0.03% of patients. CONCLUSIONS: Long-term outcomes following ventral hernia repair with P4HB mesh demonstrate low recurrence rates at 3-year (36-month) postoperative time frame with no patients developing late mesh complications or requiring mesh removal. 5-year (60-month) follow-up is ongoing.

Comparison of Oral Iron Supplement Formulations for Normalization of Iron Status Following Roux-EN-y Gastric Bypass Surgery: a Randomized Trial.

BACKGROUND: The evidence behind recommendations for treatment of iron deficiency (ID) following roux-en-y gastric bypass surgery (RYGB) lacks high quality studies. SETTING: Academic, United States OBJECTIVE: The objective of the study is to compare the effectiveness of oral iron supplementation using non-heme versus heme iron for treatment of iron deficiency in RYGB patients. METHODS: In a randomized, single-blind study, women post-RYGB and iron deficient received non-heme iron (FeSO4, 195 mg/day) or heme iron (heme-iron-polypeptide, HIP, 31.5 to 94.5 mg/day) for 8 weeks. Measures of iron status, including blood concentrations of ferritin, soluble transferrin receptor (sTfR), and hemoglobin, were assessed. RESULTS: At baseline, the mean ± standard deviation for age, BMI, and years since surgery of the sample was 41.5 ± 6.8 years, 34.4 ± 5.9 kg/m2, and 6.9 ± 3.1 years, respectively; and there were no differences between FeSO4 (N = 6) or HIP (N = 8) groups. Compliance was greater than 94%. The study was stopped early due to statistical and clinical differences between groups. Values before and after FeSO4 supplementation, expressed as least square means (95% CI) were hemoglobin, 10.8 (9.8, 11.9) to 13.0 (11.9, 14.0) g/dL; sTfR, 2111 (1556, 2864) to 1270 (934, 1737) µg/L; ferritin, 4.9 (3.4, 7.2) to 15.5 (10.6, 22.6) µg/L; and sTfR:ferritin ratio, 542 (273, 1086) to 103 (51, 204); all p < 0.0001. With HIP supplementation, no change was observed in any of the iron status biomarkers (all p > 0.05). CONCLUSIONS: In accordance with recommendations, oral supplementation using FeSO4, but not HIP, was efficacious for treatment of iron deficiency after RYGB.

Prospective evaluation of poly-4-hydroxybutyrate mesh in CDC class I/high-risk ventral and incisional hernia repair: 18-month follow-up.

BACKGROUND: Long-term resorbable mesh represents a promising technology for complex ventral and incisional hernia repair (VIHR). Preclinical studies indicate that poly-4-hydroxybutyrate (P4HB) resorbable mesh supports strength restoration of the abdominal wall. This study evaluated outcomes of high-risk subjects undergoing VIHR with P4HB mesh. METHODS: This was a prospective, multi-institutional study of subjects undergoing retrorectus or onlay VIHR. Inclusion criteria were CDC Class I, defect 10-350 cm2, ≤ 3 prior repairs, and ≥ 1 high-risk criteria (obesity (BMI: 30-40 kg/m2), active smoker, COPD, diabetes, immunosuppression, coronary artery disease, chronic corticosteroid use, hypoalbuminemia, advanced age, and renal insufficiency). Physical exam and/or quality of life surveys were performed at regular intervals through 18 months (to date) with longer-term, 36-month follow-up ongoing. RESULTS: One hundred and twenty-one subjects (46M, 75F) with an age of 54.7 ± 12.0 years and BMI of 32.2 ± 4.5 kg/m2 (mean ± SD), underwent VIHR. Comorbidities included the following: obesity (n = 95, 78.5%), hypertension (n = 72, 59.5%), cardiovascular disease (n = 42, 34.7%), diabetes (n = 40, 33.1%), COPD (n = 34, 28.1%), malignancy (n = 30, 24.8%), active smoker (n = 28, 23.1%), immunosuppression (n = 10, 8.3%), chronic corticosteroid use (n = 6, 5.0%), advanced age (n = 6, 5.0%), hypoalbuminemia (n = 3, 2.5%), and renal insufficiency (n = 1, 0.8%). Hernia types included the following: primary ventral (n = 17, 14%), primary incisional (n = 54, 45%), recurrent ventral (n = 15, 12%), and recurrent incisional hernia (n = 35, 29%). Defect and mesh size were 115.7 ± 80.6 and 580.9 ± 216.1 cm2 (mean ± SD), respectively. Repair types included the following: retrorectus (n = 43, 36%), retrorectus with additional myofascial release (n = 45, 37%), onlay (n = 24, 20%), and onlay with additional myofascial release (n = 8, 7%). 95 (79%) subjects completed 18-month follow-up to date. Postoperative wound infection, seroma requiring intervention, and hernia recurrence occurred in 11 (9%), 7 (6%), and 11 (9%) subjects, respectively. CONCLUSIONS: High-risk VIHR with P4HB mesh demonstrated positive outcomes and low incidence of hernia recurrence at 18 months. Longer-term 36-month follow-up is ongoing.

Multicenter, Prospective, Longitudinal Study of the Recurrence, Surgical Site Infection, and Quality of Life After Contaminated Ventral Hernia Repair Using Biosynthetic Absorbable Mesh: The COBRA Study.

OBJECTIVE: The aim of the study was to evaluate biosynthetic absorbable mesh in single-staged contaminated (Centers for Disease Control class II and III) ventral hernia (CVH) repair over 24 months. BACKGROUND: CVH has an increased risk of postoperative infection. CVH repair with synthetic or biologic meshes has reported chronic biomaterial infections and high hernia recurrence rates. METHODS: Patients with a contaminated or clean-contaminated operative field and a hernia defect at least 9 cm had a biosynthetic mesh (open, sublay, retrorectus, or intraperitoneal) repair with fascial closure (n = 104). Endpoints included overall Kaplan-Meier estimates for hernia recurrence and postoperative wound infection rates at 24 months, and the EQ-5D and Short Form 12 Health Survey (SF-12). Analyses were conducted on the intent-to-treat population, and health outcome measures evaluated using paired t tests. RESULTS: Patients had a mean age of 58 years, body mass index of 28 kg/m, 77% had contaminated wounds, and 84% completed 24-months follow-up. Concomitant procedures included fistula takedown (n = 24) or removal of infected previously placed mesh (n = 29). Hernia recurrence rate was 17% (n = 16). At the time of CVH repair, intraperitoneal placement of the biosynthetic mesh significantly increased the risk of recurrences (P ≤ 0.04). Surgical site infections (19/104) led to higher risk of recurrence (P < 0.01). Mean 24-month EQ-5D (index and visual analogue) and SF-12 physical component and mental scores improved from baseline (P < 0.05). CONCLUSIONS: In this prospective longitudinal study, biosynthetic absorbable mesh showed efficacy in terms of long-term recurrence and quality of life for CVH repair patients and offers an alternative to biologic and permanent synthetic meshes in these complex situations.

Long-term follow-up results of endoscopic treatment of gastroesophageal reflux disease with the MUSE™ endoscopic stapling device.

BACKGROUND: The initial 6-month data for MUSE™ (Medigus, Omer, Israel) endoscopic stapling device were reported (Zacherl et al. in Surg Endosc 29:220-229, 2015). The current study aims to evaluate the long-term clinical outcome of 37 patients who received endoscopic gastroesophageal reflux disease (GERD) treatment with the MUSE™ device. METHODS: Efficacy and safety data for 37 patients were analyzed at baseline, 6 months, and 4 years post-procedure. In one center (IU), efficacy and safety data were evaluated at baseline, 6 months post-procedure, and then annually up to 4 years. RESULTS: No new complications have been reported in our long-term analysis. The proportions of patients who remained off daily PPI were 83.8 % (31/37) at 6 months and 69.4 % (25/36) at 4 years post-procedure. GERD-Health Related Quality of Life (HRQL) scores (off PPI) were significantly decreased from baseline to 6 months and 4 years post-procedure. The daily dosage of GERD medications, measured as omeprazole equivalents (mean ± SD, mg), decreased from 66.1 ± 33.2 at baseline to 10.8 ± 15.9 at 6 months and 12.8 ± 19.4 at 4 years post-procedure (P < 0.01). CONCLUSIONS: In our multi-center prospective study, the MUSE™ stapling device appears to be safe and effective in improving symptom scores as well as reducing PPI use in patients with GERD. These results appeared to be equal to or better than those of the other devices for endoluminal GERD therapy. Future studies with larger patient series, sham control group, and greater number of staples are awaited.

Endoscopic anterior fundoplication with the Medigus Ultrasonic Surgical Endostapler (MUSE™) for gastroesophageal reflux disease: 6-month results from a multi-center prospective trial.

BACKGROUND: Both long-term proton pump inhibitor (PPI) use and surgical fundoplication have potential drawbacks as treatments for chronic gastroesophageal reflux disease (GERD). This multi-center, prospective study evaluated the clinical experiences of 69 patients who received an alternative treatment: endoscopic anterior fundoplication with a video- and ultrasound-guided transoral surgical stapler. METHODS: Patients with well-categorized GERD were enrolled at six international sites. Efficacy data was compared at baseline and at 6 months post-procedure. The primary endpoint was a ≥ 50 % improvement in GERD health-related quality of life (HRQL) score. Secondary endpoints were elimination or ≥ 50 % reduction in dose of PPI medication and reduction of total acid exposure on esophageal pH probe monitoring. A safety evaluation was performed at time 0 and weeks 1, 4, 12, and 6 months. RESULTS: 66 patients completed follow-up. Six months after the procedure, the GERD-HRQL score improved by >50 % off PPI in 73 % (48/66) of patients (95 % CI 60-83 %). Forty-two patients (64.6 %) were no longer using daily PPI medication. Of the 23 patients who continued to take PPI following the procedure, 13 (56.5 %) reported a ≥ 50 % reduction in dose. The mean percent of total time with esophageal pH <4.0 decreased from baseline to 6 months (P < 0.001). Common adverse events were peri-operative chest discomfort and sore throat. Two severe adverse events requiring intervention occurred in the first 24 subjects, no further esophageal injury or leaks were reported in the remaining 48 enrolled subjects. CONCLUSIONS: The initial 6-month data reported in this study demonstrate safety and efficacy of this endoscopic plication device. Early experience with the device necessitated procedure and device changes to improve safety, with improved results in the later portion of the study. Continued assessment of durability and safety are ongoing in a three-year follow-up study of this patient group.

Laparoscopic sleeve gastrectomy is safe and effective in elderly patients: a comparative analysis.

BACKGROUND: Laparoscopic sleeve gastrectomy (SG) is gaining widespread popularity as a definitive bariatric operation that provides satisfactory and durable weight loss as well as comorbidity resolution. Although SG is being increasingly offered to patients of all ages, there is a paucity of reported outcomes in patients ≥62 years of age. The purpose of this study was to perform a comparative analysis of the outcomes of SG in patients >62 years versus a younger age group, with an emphasis on safety and efficacy. METHODS: A retrospective analysis was performed from a prospectively collected database on patients who underwent SG from 2007 to 2012. All patients who were ≥62 years old were compared to those <62 years. RESULTS: There were 182 patients who underwent SG, 17 of whom were ≥62 years old. There were no significant differences in demographics or comorbidity characteristics between the groups. The mean follow-up was 1 year. There was no 30-day mortality in either group. The percent excess weight loss for the younger age group was 44 ± 21 % and the older group was 44 ± 25 %. The percent total body weight loss was 22 ± 10 and 21 ± 10 %, respectively. Weight loss outcomes were maintained for up to 3 years. Comorbidity resolution and improvement rates were equivalent in both groups. CONCLUSIONS: SG is safe and effective in patients ≥62 years. Weight loss and the beneficial effects on comorbidities are equivalent among elderly and younger patients. SG should be offered to elderly patients who are deemed to be appropriate candidates.

Deep sedation in natural orifice transluminal endoscopic surgery (NOTES): a comparative study with dogs.

BACKGROUND: Natural orifice transluminal endoscopic surgery (NOTES) has been mostly performed with the animal under general and inhalational anesthesia (IA-NOTES). To date, NOTES using propofol sedation (PS-NOTES) has not been investigated. This study aimed to assess the feasibility and safety of PS-NOTES for transgastric oophorectomy with carbon dioxide insufflation and to compare its success rates with those of conventional IA-NOTES. METHODS: In this prospective randomized study, NOTES oophorectomy was performed for 19 female dogs randomized to two conditions: PS (study group) and IA (control group). Sedation success rates (ability to visualize and resect ovaries without converting to IA), operative success rates (ability to resect and retrieve both ovaries in full using only NOTES), and vital parameters including hemodynamic and respiratory changes were documented. RESULTS: In the PS-NOTES group (n = 9), the sedation success rate was 100 %. The operative success rate was 67 % (6 of 9 animals) compared with 80 % (8 of 10 animals) in the IA-NOTES group. No purposeful movement occurred during surgical manipulation and no respiratory or cardiovascular complications in occurred the PS group. Heart rate (HR) and end-tidal carbon dioxide (ETCO(2)) were significantly higher in the PS group than in the IA group. Blood pressure (BP) was significantly higher in the PS group only during the middle part of the procedure. Only mild respiratory depression was noted in the PS group, as indicated by elevated but acceptable ETCO(2). Elevations in BP and HR are thought to be related to elevated CO(2) but did not appear to have an adverse impact on the course of the procedure. Recovery was uneventful for all the animals. CONCLUSION: The use of PS-NOTES appears to be feasible, resulting in outcomes comparable with those for IA in dogs. Further studies are needed to determine the applicability of this concept in human NOTES.

Single-port laparoscopic right hemicolectomy: the first 100 resections.

BACKGROUND: Single-port laparoscopy remains a novel technique in the field of colorectal surgery. Several small series have examined its safety for colon resection. OBJECTIVE: Our aim was to analyze our entire experience and short-term outcomes with single-port laparoscopic right hemicolectomy since its introduction at our institution. We assert that this approach is feasible and safe for the wide array of patients and indications encountered by a colorectal surgeon. DESIGN: This is a retrospective analysis of prospectively gathered data for all patients who underwent single-port laparoscopic right hemicolectomy with the use of standard laparoscopic instrumentation, for malignant or benign disease, between July 2009 and November 2010 in a high-volume, academic, colorectal surgery practice. MAIN OUTCOME MEASURES: Demographic, clinical, operative, and pathologic factors were reviewed and analyzed. All conversions to conventional laparoscopic or open operations were considered in this analysis. RESULTS: One hundred patients underwent single-port laparoscopic right hemicolectomy during the study period. Mean age was 63 years, and 61% of the patients were men. Forty-three percent had undergone previous abdominal surgery, and the median body mass index was 26 (range, 18-46). Median ASA classification was 3 (range, 1-4). Five percent of the operations were performed urgently, and 56% were performed for carcinoma, of which half were T3 or T4 tumor stage. Median operative duration was 105 (range, 64-270) minutes. Mean and median blood loss was 106 and 50 mL. Two percent required conversion to multiport laparoscopy, and 4% converted to the open approach. Median postoperative stay was 4 (range, 2-48) days. Median lymph node number was 18 (range, 11-42). There was one mortality in this series. Morbidity, including wound infection, was 13%. CONCLUSIONS: This represents the largest experience with single-port laparoscopic right hemicolectomy to date. This technique was used with acceptable morbidity and mortality and without compromise of conventional oncologic parameters by colorectal surgeons experienced in minimally invasive technique. These findings support the use of a single-port approach for patients requiring right hemicolectomy.

Pancreas transplantation after bariatric surgery.

Obese transplant candidates are at increased risk for perioperative and postoperative complications. In many transplant programs, morbid obesity is considered to be an exclusion criterion for transplantation. The only potential option that would grant these patients access to transplant is weight loss. Non-operative weight loss strategies such as behavioral modifications, exercise, diet, or medication have only very limited success in achieving long-term weight loss. In contrast, bariatric surgery was shown to achieve not only more excessive weight loss, but more importantly, this weight loss can be sustained for longer periods of time. Therefore, bariatric surgery presents an attractive option for weight loss for morbidly obese transplant candidates. We report our experience with four patients who underwent bariatric surgery prior to successful pancreas transplantation. Even though gastric bypass and laparoscopic adjustable gastric band present as equivalent alternatives for weight reduction, we believe that in the population of morbidly obese diabetic patients who are possible candidates for pancreas transplantation, laparoscopic adjustable gastric band placement is the more suitable procedure.

Comparison of hand-sewn, linear-stapled, and circular-stapled gastrojejunostomy in laparoscopic Roux-en-Y gastric bypass.

BACKGROUND: There is no consensus on the ideal gastrojejunostomy anastomosis (GJA) technique in laparoscopic Roux-en-Y gastric bypass (LRYGB). We reviewed our experience with three GJA techniques (hand-sewn (HSA), linear-stapled (LSA), and 25-mm circular-stapled (CSA)) to determine which anastomosis technique is associated with the lowest early (60-day) anastomotic complication rates. METHODS: From November 2004 through December 2009, 882 consecutive patients underwent LRYGB using three GJA techniques: HSA, LSA, and CSA. All patients had a minimum of 2 months follow-up. Records were reviewed for postoperative gastrojejunostomy leak, stricture, and marginal ulcer, and these early complications were classified according to anastomosis technique. Multivariate analysis was performed to determine associations between complications and anastomosis technique. RESULTS: Preoperative demographics, length of hospital stay, and postoperative follow-up did not differ between the three groups. The majority of patients underwent LSA (n = 514, 61.6%) followed by HSA (n = 180, 21.6%) and CSA (n = 140, 16.8%). Using multivariate analysis, there were no statistically significant differences in the rates of leak (LSA 1.0%, HSA 1.1%, CSA 0.0%, p = 0.480), stricture (LSA 6.0%, HSA 6.1%, CSA 4.3%, p = 0.657), or marginal ulcer (LSA 8.0%, HSA 7.7%, CSA 3.6%, p = 0.180). CONCLUSIONS: The three techniques can be used safely with a low complication rate. Our data do not identify a superior anastomosis technique.

Evaluation of the learning curve for natural orifice transluminal endoscopic surgery: bilateral ovariectomy in dogs.

OBJECTIVE: Study the learning curve for canine Natural Orifice Transluminal Endoscopic Surgery (NOTES) ovariectomy by evaluating operative times and complications. STUDY DESIGN: Preclinical research study. ANIMALS: Adult female dogs (n=20). METHODS: NOTES ovariectomy procedures were performed as follows: Feasibility Group 1 (n=5), Feasibility Group 2 (n=5), and Early Clinical Group 3 (n=10). Six steps of the procedure were identified, timed separately, and the overall time was recorded from introduction to removal of the endoscope. Complications were recorded. Repeated measures analysis of variance using ranked data compared the effect of group (3 levels) on the time for each step. Nonlinear regression using an exponential model with nonzero asymptote was used to model the operative time-procedure number relationship. RESULTS: Overall median operative time was significantly longer for Group 1 (195 minutes; range, 160-265 minutes) than Group 2 (108 minutes; range, 81-148 minutes; P=.048) and Group 3 (77 minutes; range, 41-136 minutes; P=.0008). The estimated asymptotic operative time was 71 minutes (95% confidence interval, 41-100 minutes); this time was reached after 10 procedures. Gastric cleansing and removing the left ovary took significantly longer in Group 1 than in Group 2 or 3. Operative complications included incomplete ovarian excision, dropping an ovary during retrieval, and conversion to an open procedure. No intraoperative complications occurred in Group 3. CONCLUSION: NOTES procedures result in longer operative times in the early part of the learning curve and require considerable experience before reaching proficiency.

Single-port laparoscopic right hemicolectomy: a safe alternative to conventional laparoscopy.

PURPOSE: Single-port laparoscopic surgery has evolved from an effort to minimize tissue trauma, limit morbidity, and maximize cosmesis. Limited data exist comparing single-port with conventional laparoscopy for right colectomy. Our aim is to compare single-port with laparoscopic colectomy with regard to safety and feasibility. We assert that this approach can be adopted in a safe and efficacious manner while using standard laparoscopic instrumentation. METHODS: This is a retrospective analysis of prospectively gathered data regarding 16 single-port and 27 conventional laparoscopic right hemicolectomies performed by a single surgeon between January 2008 and February 2009. Demographics, operative outcomes, and morbidity were included and analyzed using either Student t test or Fisher exact probability test. RESULTS: Single-port and conventional laparoscopic groups were similar with regard to age, gender, body mass index, prior abdominal surgery, and co-morbidity. Seventy-five percent and 70% of the operations were performed for malignancy in the single-port and the conventional laparoscopy group, respectively (P = .69). Operative duration was 106 minutes in the single-port group vs 100 minutes in the conventional group (P = .64). Blood loss was 54 mL and 90 mL, respectively (P = .07). No conversions or additions of ports occurred. Hospital stay was 5.3 days in the single-port group vs 6 days in the conventional group (P = .53). Margins were negative in both groups. Mean lymph node number was 18 and 16 nodes (P = .92). There was one death in the conventional group (P = .44). Morbidity including wound infection was 18.8% and 14.9%, respectively (P = .73). CONCLUSIONS: These findings support single-port right colectomy as a safe and efficacious approach to right colon resections in patients eligible for laparoscopy with minimal additional equipment or learning curve for experienced laparoscopic colorectal surgeons. The single port was undertaken without an increase in morbidity or mortality. There was no increase in operative time with use of the single-port approach. Finally, adequate lymph node harvest and margin clearance was maintained.