Robotic Versus Laparoscopic Ventral Hernia Repair: Two-Year Results From a Prospective, Multicenter, Blinded Randomized Clinical Trial.

OBJECTIVE: Report the 2-year outcomes of a multicenter randomized controlled trial comparing robotic versus laparoscopic intraperitoneal onlay mesh ventral hernia repair. BACKGROUND: Ventral hernia repair is one of the most common operations performed by general surgeons. To our knowledge, no studies have been published to date comparing long-term outcomes of laparoscopic versus robotic ventral hernia repair. METHODS: The trial was registered at clinicaltrials.gov (NCT03490266). Clinical outcomes included surgical site infection, surgical site occurrence, hernia occurrence, readmission, reoperation, and mortality. RESULTS: A total of 175 consecutive patients were approached that were deemed eligible for elective minimally invasive ventral hernia repair. In all, 124 were randomized and 101 completed follow-up at 2 years. Two-year follow-up was completed in 54 patients (83%) in the robotic arm and 47 patients (80%) in the laparoscopic arm. No differences were seen in surgical site infection or surgical site occurrence. Hernia recurrence occurred in 2 patients (4%) receiving robotic repair versus in 6 patients (13%) receiving laparoscopic repair (relative risk: 0.3, 95% CI: 0.06-1.39; P =0.12). No patients (0%) required reoperation in the robotic arm whereas 5 patients (11%) underwent reoperation in the laparoscopic arm ( P =0.019, relative risk not calculatable due to null outcome). CONCLUSIONS: Robotic ventral hernia repair demonstrated at least similar if not improved outcomes at 2 years compared with laparoscopy. There is potential benefit with robotic repair; however, additional multi-center trials and longer follow-up are needed to validate the hypothesis-generating findings of this study.

Robotic Versus Laparoscopic Ventral Hernia Repair: One-year Results From a Prospective, Multicenter, Blinded Randomized Controlled Trial.

OBJECTIVE: The aim of this study was to compare clinical and patient-reported outcomes of robotic versus laparoscopic ventral hernia repair (LVHR) at 1-year postoperative. SUMMARY OF BACKGROUND DATA: Despite a relative lack of research at low risk for bias assessing robotic ventral hernia repair (RVHR), the growth of RVHR has been rapid. We previously reported short-term results of the first randomized control trial comparing RVHR versus LVHR; there was no clear difference in clinical outcomes but increased operative time and cost with robotic repair. METHODS: Patients from a multicenter, blinded randomized control trial comparing RVHR versus LVHR were followed at 1 year. Outcomes included wound complication (surgical site infection, surgical site occurrence, wound dehiscence), hernia occurrence including recurrence and port site hernia, readmission, reoperation, and patient-reported outcomes (functional status, pain, and satisfaction with repair and cosmesis). RESULTS: A total of 124 patients were randomized and 113 patients (91%; 60 robot, 53 laparoscopic) completed 1-year follow-up. Baseline demographics were similar in both groups. No differences were seen in wound complication (15% vs 15%; P = 0.899), hernia recurrence (7% vs 9%; P = 0.576), or readmission (2% vs 6%; P = 0.251). No patients underwent reoperation in the robotic arm, whereas 5 (9%) did in the laparoscopic arm (P = 0.020). No differences were seen in patient-reported outcomes. Both arms reported clinically significant improvements in functional status, low pain scores, and high satisfaction scores at 1-year post repair. CONCLUSION: This study confirms that robotic ventral hernia repair is safe when compared to laparoscopy. Further studies are needed to confirm these findings.

Outcomes of primary versus revisional robotically assisted laparoscopic Roux-en-Y gastric bypass: a multicenter analysis of ten-year experience.

BACKGROUND: Postoperative morbidity after laparoscopic bariatric surgery is considered higher for patients undergoing revisional versus primary procedures. The objective of this retrospective cohort study was to compare outcomes between patients undergoing primary versus revisional robotically assisted laparoscopic (RAL) Roux-en-Y gastric bypass (RYGB). METHODS: Data of all patients who underwent RAL primary and revisional RYGB between 2009 and 2019 at two accredited, high-volume bariatric surgery centers-the Memorial Hermann - Texas Medical Center, Houston, TX, and the Tower Health, Reading Hospital, Reading, PA, were analyzed. Primary outcomes were early (< 30 days) and overall postoperative complications. Secondary outcomes included intraoperative complications, operative times, conversions to laparotomy, length of hospital stay, early (< 30 days) postoperative readmissions and deaths. RESULTS: Data of 1072 patients were analyzed, including 806 primary and 266 revisional RAL RYGB procedures. Longer operative times (203 versus 154 min, P < 0.001), increased number of readmissions for oral intolerance (10.5% versus 6.7%, P = 0.046) and higher rate of gastrojejunal stricture (6.4% versus 2.7%, P = 0.013) were found in the revisional group. Gastrointestinal leak rates were 0.2% for the primary versus 1.1% for the revisional group (P = 0.101). Early (< 30 days) reoperations rates were 2.2% for the primary versus 1.1% for the revisional group (P = 0.318). There were no statistically significant differences between groups in overall and severe complication rates. CONCLUSION: Patients undergoing RAL primary and revisional RYGB had comparable overall outcomes, with a non-significant higher early complication rate in the revisional group. Despite the study being underpowered to detect differences in specific complication rates, the morbidity seen in the revisional RYGB group remains markedly below literature reports of revisional laparoscopic RYGB and might suggest a benefit of robotic assistance. Further prospective studies are needed to confirm these results.

Trocar site closure with a novel anchor-based (neoClose®) system versus standard suture closure: a prospective randomized controlled trial.

BACKGROUND: Patients with obesity have a higher risk of trocar site hernia. The objective of the present study was to compare a standard suture passer versus the neoClose® device for port site fascial closure in patients with obesity undergoing laparoscopic bariatric surgery. METHODS: This is a randomized, controlled trial with two parallel arms. Thirty five patients with BMI ≥ 35 kg/m2 and undergoing laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass were randomized to each group. Port site fascial closure for trocars ≥ 10 mm was performed with the neoClose® device in the study group and the standard suture passer in the control group. Primary outcomes were time required to complete closure and intensity of postoperative pain at the fascial closure sites. Secondary outcomes were intraabdominal needle depth and incidence of trocar site hernia. RESULTS: The use of the neoClose® device resulted in shorter closure times (20.2 vs 30.0 s, p = 0.0002), less pain (0.3 vs 0.9, p = 0.002) at port closure sites, and decreased needle depth (3.3 cm vs 5.2 cm, p < 0.0001) compared to the standard suture passer. There was no trocar site hernia at the one-year follow-up in either group. CONCLUSIONS: Use of the neoClose® device resulted in faster fascial closure times, decreased intraoperative needle depth, and decreased postoperative abdominal pain at 1 week as compared to the standard suture passer. These data need to be confirmed on larger cohorts of patients with longer follow-up.

Safety of robotic assisted laparoscopic recurrent paraesophageal hernia repair: insights from a large single institution experience.

BACKGROUND: Laparoscopic repair of recurrent as opposed to primary paraesophageal hernias (PEHs) are historically associated with increased peri-operative complication rates, worsened outcomes, and increased conversion rates. The robotic platform may aid surgeons in these complex revision procedures. The aim of this study was to compare the outcomes of patients undergoing robotic assisted laparoscopic (RAL) repair of recurrent as opposed to primary PEHs. METHODS: Patients undergoing RAL primary and recurrent PEH repairs from 2009 to 2017 at a single institution were reviewed. Demographics, use of mesh, estimated blood loss, intra-operative complications, conversion rates, operative time, rates of esophageal/gastric injury, hospital length of stay, re-admission/re-operation rates, recurrence, dysphagia, gas bloat, and pre- and post-operative proton pump inhibitor (PPI) use were analyzed. Analysis was accomplished using Chi-square test/Fischer's exact test for categorical variables and the Mann-Whitney U test for continuous variables. RESULTS: There were 298 patients who underwent RAL PEH repairs (247 primary, 51 recurrent). They were followed for a median (interquartile range) of 120 (44, 470) days. There were no significant differences in baseline demographics between groups. Patients in the recurrent PEH group had longer operative times, increased use of mesh, and increased length of hospital stay. They were also less likely to undergo fundoplication. There were no significant differences in estimated blood loss, incidence of intra-operative complications, re-admission rates, incidence of post-operative dysphagia and gas bloat, and incidence of post-operative PPI use. There were no conversions to open operative intervention or gastric/esophageal injury/leaks. CONCLUSIONS: Although repair of recurrent PEHs are historically associated with worse outcomes, in this series, RAL recurrent PEH repairs have similar peri-operative and post-operative outcomes as compared to primary PEH repairs. Whether this is secondary to the potential advantages afforded by the robotic platform deserves further study.

Correction to: Trocar site closure with a novel anchor-based (neoClose®) system versus standard suture closure: a prospective randomized controlled trial.

After careful review, the authors have noticed the following mistakes in the article entitled "Trocar site closure with a novel anchor based (neoClose®) system versus standard suture closure: A prospective randomized controlled trial": - Correct closure times are 19.9 seconds (SD 9.9) for the study group and 31.0 seconds (SD 20.1) for the control group (initial incorrect values were 20.2 seconds (SD 10.1) and 30 seconds (SD 19.1) respectively). The new correct P-value is <0.0001 (initial incorrect P-value was 0.0002). - Correct maximal needle depth values are 3.2 cm (SD 0.93) for the study group and 4.9 cm (SD 1.97) for the control group (initial incorrect values were 3.3 cm (SD 0.9) and 5.2 cm (SD 1.6) respectively). P-value remains unchanged at <0.0001. For these two outcomes, some values of control group patients were mistakenly included in the study group. These errors only marginally affected the mean and standard deviation values. Statistical significance of the results was not affected and the conclusions of the study remain unchanged.

Stent induced gastric wall erosion and endoscopic retrieval of nonadjustable gastric band: a new technique.

INTRODUCTION: In gastrointestinal surgery, specifically in bariatric surgery, there are many types of fixed bands used for restriction and there are a multitude reasons that might eventually be an impetus for the removal of those bands. Bands consisting of Marlex or non silastic materials can be extremely difficult to remove. Intraoperative complications removing fixed bands include the difficulty in locating the band, inability to remove all of the band, and damage to surrounding structures including gastrotomies. Removal of eroded bands endoscopically may pose less risk. Potentially, forced erosion may be an easier modality than surgery, allowing revision without having to deal with the actual band at the time of definitive revision surgery. METHODS: A retrospective case series developed from a university single institution bariatric practice setting was utilized. Endpoints for the study include success of band removal, complications, length of time the stent was present, and the type of stent. RESULTS: A total of 15 consecutive cases utilizing endoscopic stenting to actively induce fixed gastric band erosion for subsequent endoscopic removal were reviewed. There was an 87 % success rate in complete band removal with partial removal of the remaining bands that resolved the patient's symptoms. A complication rate of 27 % was recorded among the 15 patients, consisting of pain and/or nausea and vomiting. The mean time period of the placement of the stent prior to removal or attempted removal was 16.3 days. CONCLUSION: Endoscopic forced erosion of fixed gastric bands is feasible, safe, and may offer an advantage over laparoscopic removal. This technique is especially applicable for gastric obstruction from fixed bands, prior to large and definitive revision surgeries, or anticipated hostile anatomy that might preclude an abdominal operation altogether.

Ensuring competency: are fundamentals of laparoscopic surgery training and certification necessary for practicing surgeons and operating room personnel?

BACKGROUND: Certification in fundamentals of laparoscopic surgery (FLS) is required by the American board of surgery for graduating residents. This study aimed to evaluate the feasibility and need for certifying practicing surgeons and to assess proficiency of operating room (OR) personnel. METHODS: Through a patient safety and health care delivery effectiveness grant, investigators at four state medical schools received funding for FLS certification of all attending surgeons and OR personnel credentialed in laparoscopy. Data were voluntarily collected under an institutional review board-approved protocol. Surgeons performed a single repetition of the FLS tasks oriented to the FLS proficiency-based curriculum and online cognitive materials and were encouraged to self-practice. The FLS certification examination was administered 2 months later under standard conditions. Operating room nurses and scrub technicians were enrolled in a curriculum with cognitive materials and a multistation skills practicum. Baseline and completion questionnaires were administered. Performance was assessed using signed-rank and χ(2) analysis. RESULTS: The study aimed to enroll 99 surgeons. Subsequently, 87 surgeons completed at least one portion of the curriculum, 72 completed the entire curriculum (73% compliance), 83 completed the baseline skills assessment, and 27 (33%) failed. The self-reported practice time was 3.7 ± 2.5 h. At certification (n = 76), skills performance had improved from 317 ± 102.9 to 402 ± 54.2 (p < 0.0001). One surgeon (1.3%) failed the skills certification, and nine (11.8%) failed the cognitive exam. Remediation was completed by six surgeons. Of the 64 enrolled OR personnel, 22 completed the curriculum (34% compliance). All achieved proficiency at skills, and 60% passed the cognitive exam. CONCLUSIONS: This study demonstrated that FLS certification for practicing surgeons and proficiency verification for OR personnel are feasible. A baseline skills failure rate of 33% and a certification failure rate of 13% suggest that FLS certification may be necessary to ensure surgeon competency. Fortunately, with only moderate practice, significant improvement can be achieved.

Thromboelastography-Based Profiling of Coagulation Status in Patients Undergoing Bariatric Surgery: Analysis of 422 Patients.

INTRODUCTION/PURPOSE: Some clinical indicators suggest hypercoagulability/hyperaggregability in patients with morbid obesity. Thromboelastography (TEG®) has been used to profile coagulation status in surgical patients. We aimed to assess coagulation profiles in patients with morbid obesity undergoing bariatric surgery by correlating demographic and patient characteristics to pre-operative TEG® values. MATERIALS AND METHODS: Pre-operative TEG® values from 422 patients undergoing bariatric surgery were evaluated. TEG® results were analyzed by gender, use of medications known to alter the coagulation profile, and body mass index (BMI). RESULTS: Patients have a mean of 45.03 ± 11.8 years, female (76.3%), and with a mean BMI of 42 kg/m 1. The overall coagulation profile of female patients was significantly different from males, even in the sub-cohort without use of medications known to alter coagulation. The majority of patients (94%) with a G value > 15 dynes/cm 1 (clot strength) were female. In females, there was no association between BMI and TEG® values; however, in men, there was a statistically significant difference in TEG® values for those with BMI < 40 kg/m 1 compared to those with BMI > 50 kg/m2. CONCLUSIONS: TEG®-based analysis of coagulation profiles offers unique insights. Compared to laboratory normal values (R time, angle, maximal amplitude, and G values), patients with morbid obesity may have a tendency for hypercoagulability/hyperaggregability, with mean values at the higher limit. A significant hypercoagulable difference in TEG® values was identified in female as compared to male patients. Male patients with a BMI greater than 50 kg/m2 were also found to be increasingly hypercoagulable.

Robotic versus laparoscopic ventral hernia repair: multicenter, blinded randomized controlled trial.

OBJECTIVE: To determine whether robotic ventral hernia repair is associated with fewer days in the hospital 90 days after surgery compared with laparoscopic repair. DESIGN: Pragmatic, blinded randomized controlled trial. SETTING: Multidisciplinary hernia clinics in Houston, USA. PARTICIPANTS: 124 patients, deemed appropriate candidates for elective minimally invasive ventral hernia repair, consecutively presenting from April 2018 to February 2019. INTERVENTIONS: Robotic ventral hernia repair (n=65) versus laparoscopic ventral hernia repair (n=59). MAIN OUTCOME MEASURES: The primary outcome was number of days in hospital within 90 days after surgery. Secondary outcomes included emergency department visits, operating room time, wound complications, hernia recurrence, reoperation, abdominal wall quality of life, and costs from the healthcare system perspective. Outcomes were pre-specified before data collection began and analyzed as intention to treat. RESULTS: Patients from both groups were similar at baseline. Ninety day follow-up was completed in 123 (99%) patients. No evidence was seen of a difference in days in hospital between the two groups (median 0 v 0 days; relative rate 0.90, 95% confidence interval 0.37 to 2.19; P=0.82). For secondary outcomes, no differences were noted in emergency department visits, wound complications, hernia recurrence, or reoperation. However, robotic repair had longer operative duration (141 v 77 min; mean difference 62.89, 45.75 to 80.01; P≤0.001) and increased healthcare costs ($15 865 (£12 746; €14 125) v $12 955; cost ratio 1.21, 1.07 to 1.38; adjusted absolute cost difference $2767, $910 to $4626; P=0.004). Among patients with robotic ventral hernia repair, two had an enterotomy compared none with laparoscopic repair. The median one month postoperative improvement in abdominal wall quality of life was 3 with robotic ventral hernia repair compared with 15 following laparoscopic repair. CONCLUSION: This study found no evidence of a difference in 90 day postoperative hospital days between robotic and laparoscopic ventral hernia repair. However, robotic repair increased operative duration and healthcare costs. TRIAL REGISTRATION: Clinicaltrials.gov NCT03490266.