Open Retromuscular Sugarbaker vs Keyhole Mesh Placement for Parastomal Hernia Repair: A Randomized Clinical Trial.

Importance: Durable parastomal hernia repair remains elusive. There is limited evidence comparing the durability of the open retromuscular Sugarbaker and keyhole mesh configurations. Objective: To determine if the open retromuscular Sugarbaker mesh placement technique would lower parastomal hernia recurrence rates. Design, Setting, and Participants: In this single-center, randomized clinical trial, 150 patients with a permanent stoma and associated parastomal hernia who were candidates for open retromuscular parastomal hernia repair were enrolled and randomized from April 2019 to April 2022 and followed up for 2 years. Interventions: Following intraoperative assessment to determine the feasibility of either technique, enrolled patients were randomized to receive either retromuscular Sugarbaker or keyhole synthetic mesh placement. Main Outcomes and Measures: The primary outcome was parastomal hernia recurrence at 2 years. Secondary outcomes included mesh-related complications, wound complications, reoperations, as well as patient-reported pain, abdominal wall-specific quality of life, stoma-specific quality of life, and decision regret at 1 year and 2 years. Results: A total of 150 patients were randomized, and with 91% follow-up at 2 years, there were 13 (17%) parastomal hernia recurrences in the retromuscular Sugarbaker arm and 18 (24%) in the keyhole arm (adjusted risk difference, -0.029; 95% CI, -0.17 to 0.153, and adjusted risk ratio, 0.87; 95% CI, 0.42 to 1.69). There were no statistically significant differences between the Sugarbaker and keyhole groups regarding reoperations for recurrence (2 vs 7, respectively), nonhernia intra-abdominal pathology (4 vs 10, respectively), stoma necrosis (1 vs 0, respectively), mesh-related complications (4 vs 1, respectively), patient-reported pain, abdominal wall-specific quality of life, stoma-specific quality of life, and decision regret at any time point. Conclusions and Relevance: In the setting of open parastomal hernia repair, a retromuscular Sugarbaker mesh placement technique was not superior to a keyhole configuration 2 years after repair. Further innovation is necessary to improve parastomal hernia repair outcomes. Trial Registration: ClinicalTrials.gov Identifier: NCT03972553.

Open retromuscular keyhole compared with Sugarbaker mesh for parastomal hernia repair: Early results of a randomized clinical trial.

BACKGROUND: Open parastomal hernia repair can be performed using retromuscular synthetic mesh in a keyhole or Sugarbaker configuration. Relative morbidity and durability are unknown. Here, we present perioperative outcomes of a randomized controlled trial comparing these techniques, including 30-day patient-reported outcomes, reoperations, and wound complications in ≤90 days. METHODS: This single-center randomized clinical trial compared open parastomal hernia repair with retromuscular medium-weight polypropylene mesh in the keyhole and Sugarbaker configuration for permanent stomas between April 2019 and April 2022. Adult patients with parastomal hernias requiring open repair with sufficient bowel length for either technique were included. Patient-reported outcomes were collected at 30 days; 90-day outcomes included initial hospital length of stay, readmission, wound morbidity, reoperation, and mesh- or stoma-related complications. RESULTS: A total of 150 patients were randomized (75 keyhole and 75 Sugarbaker). There were no differences in length of stay, readmission, reoperation, recurrence, or wound complications. Twenty-four patients (16%) required procedural intervention for wound morbidity. Ten patients (6.7%) required abdominal reoperation in ≤90 days, 7 (4.7%) for wound morbidity, including 3 partial mesh excisions (1 keyhole compared with 2 Sugarbaker; P = 1). Four mesh-related stoma complications requiring reoperations occurred, including stoma necrosis (n = 1), bowel obstruction (n = 1), parastomal recurrence (n = 1), and mucocutaneous separation (n = 1), all in the Sugarbaker arm (P = .12). Patient-reported outcomes were similar between groups at 30 days. CONCLUSION: Open parastomal hernia repair with retromuscular mesh in the keyhole and Sugarbaker configurations had similar perioperative outcomes. Patients will be followed to determine long-term relative durability, which is critical to understanding each approach's risk-benefit ratio.

Laparoscopic versus robotic inguinal hernia repair: 1- and 2-year outcomes from the RIVAL trial.

INTRODUCTION: Robotic inguinal hernia repair is growing in popularity among general surgeons despite little high-quality evidence supporting short- or long-term advantages over traditional laparoscopic inguinal hernia repair. The original RIVAL trial showed increased operative time, cost, and surgeon frustration for the robotic approach without advantages over laparoscopy. Here we report the 1- and 2-year outcomes of the trial. METHODS: This is a multi-center, patient-blinded, randomized clinical study conducted at six sites from 2016 to 2019, comparing laparoscopic versus robotic transabdominal preperitoneal (TAPP) inguinal hernia repair with follow-up at 1 and 2 years. Outcomes include pain (visual analog scale), neuropathic pain (Leeds assessment of neuropathic symptoms and signs pain scale), wound morbidity, composite hernia recurrence (patient-reported and clinical exam), health-related quality of life (36-item short-form health survey), and physical activity (physical activity assessment tool). RESULTS: Early trial participation included 102 patients; 83 (81%) completed 1-year follow-up (45 laparoscopic vs. 38 robotic) and 77 (75%) completed 2-year follow-up (43 laparoscopic vs. 34 robotic). At 1 and 2 years, pain was similar for both groups. No patients in either treatment arm experienced neuropathic pain. Health-related quality of life and physical activity were similar for both groups at 1 and 2 years. No long-term wound morbidity was seen for either repair type. At 2 years, there was no difference in hernia recurrence (1 laparoscopic vs. 1 robotic; P = 1.0). CONCLUSIONS: Laparoscopic and robotic inguinal hernia repairs have similar long-term outcomes when performed by surgeons with experience in minimally invasive inguinal hernia repairs.

Robotic eTEP versus IPOM evaluation: the REVEAL multicenter randomized clinical trial.

BACKGROUND: For small to medium-sized ventral hernias, robotic intraperitoneal onlay mesh (rIPOM) and enhanced-view totally extraperitoneal (eTEP) repair have emerged as acceptable approaches that each takes advantage of robotic instrumentation. We hypothesized that avoiding mesh fixation in a robotic eTEP repair offers an advantage in early postoperative pain compared to rIPOM. METHODS: This is a multi-center, randomized clinical trial for patients with midline ventral hernias ≤ 7 cm, who were randomized to rIPOM or robotic eTEP. The primary outcome was pain (0-10) on the first postoperative day. Secondary outcomes included same-day discharge, length of stay, opioid consumption, quality of life, surgeon workload, and cost. RESULTS: Between November 2019 and November 2021, 100 patients were randomized (49 rIPOM, 51 eTEP) among 5 surgeons. Pain on the first postoperative day [median (IQR): 5 (4-6) vs. 5 (3.5-7), p = 0.66] was similar for rIPOM and eTEP, respectively, a difference maintained following adjustments for surgeon, operative time, baseline pain, and patient co-morbidities (difference 0.28, 95% CI - 0.63 to 1.19, p = 0.56). No differences in pain on the day of surgery, 7, and 30 days after surgery were identified. Same-day discharge, length of stay, opioid consumption, and 30-day quality of life were also comparable, though rIPOM required less surgeon workload (p < 0.001), shorter operative time [107 (86-139) vs. 165 (129-212) min, p < 0.001], and resulted in fewer surgical site occurrences (0 vs. 8, p = 0.004). The total direct costs for rIPOM and eTEP were comparable [$8282 (6979-11835) vs. $8680 (7550-10282), p = 0.52] as the cost savings for eTEP attributable to mesh use [$442 (434-485) vs. $69 (62-76), p = < 0.0001] were offset by increased expenses for operative time [$669 (579-861) vs. $1075 (787-1367), p < 0.0001] and use of more robotic equipment [$760 (615-933) vs. $946 (798-1203), p = 0.001]. CONCLUSION: The avoidance of fixation in a robotic eTEP repair did not reveal a benefit in postoperative pain to offset the shorter operative time and surgeon workload offered by rIPOM.

Comparing Sugarbaker versus keyhole mesh technique for open retromuscular parastomal hernia repair: study protocol for a registry-based randomized controlled trial.

BACKGROUND: Parastomal hernia, common after stoma creation, negatively impacts patient quality of life. For patients with a permanent stoma, durable parastomal hernia repair remains a challenge, with few high-quality studies for guidance. An alternative to open retromuscular parastomal hernia repair with retromuscular "keyhole" mesh is the recent Sugarbaker modification. We aim to compare these two techniques in a head-to-head prospective study. METHODS: This is a registry-based randomized controlled trial designed to investigate whether the retromuscular Sugarbaker technique is superior to the retromuscular keyhole technique for parastomal hernia repair. The primary study endpoint is parastomal hernia recurrence at 2 years. Secondary endpoints include hospital length-of-stay, readmission, wound morbidity, mesh-related complications, re-operation, all 30-day morbidity, and patient-reported outcomes, including hernia-related quality of life, stoma-specific quality of life, pain, and decision regret. DISCUSSION: Based on the post hoc analysis of a recent randomized controlled trial, we hypothesize that the retromuscular Sugarbaker technique will reduce parastomal hernia recurrence by 20% at 2 years compared to the retromuscular keyhole mesh technique. The results of this study may provide evidence-based guidance for surgeons repairing parastomal hernias. TRIAL REGISTRATION: ClinicalTrials.gov NCT03972553. Registered on 3 June 2019.

Biologic vs Synthetic Mesh for Single-stage Repair of Contaminated Ventral Hernias: A Randomized Clinical Trial.

IMPORTANCE: Biologic mesh is widely used for reinforcing contaminated ventral hernia repairs; however, it is expensive and has been associated with high rates of long-term hernia recurrence. Synthetic mesh is a lower-cost alternative but its efficacy has not been rigorously studied in individuals with contaminated hernias. OBJECTIVE: To determine whether synthetic mesh results in superior reduction in risk of hernia recurrence compared with biologic mesh during the single-stage repair of clean-contaminated and contaminated ventral hernias. DESIGN, SETTING, AND PARTICIPANTS: This multicenter, single-blinded randomized clinical trial was conducted from December 2012 to April 2019 with a follow-up duration of 2 years. The trial was completed at 5 academic medical centers in the US with specialized units for abdominal wall reconstruction. A total of 253 adult patients with clean-contaminated or contaminated ventral hernias were enrolled in this trial. Follow-up was completed in April 2021. INTERVENTIONS: Retromuscular synthetic or biologic mesh at the time of fascial closure. MAIN OUTCOMES AND MEASURES: The primary outcome was the superiority of synthetic mesh vs biologic mesh at reducing risk of hernia recurrence at 2 years based on intent-to-treat analysis. Secondary outcomes included mesh safety, defined as the rate of surgical site occurrence requiring a procedural intervention, and 30-day hospital direct costs and prosthetic costs. RESULTS: A total of 253 patients (median [IQR] age, 64 [55-70] years; 117 [46%] male) were randomized (126 to synthetic mesh and 127 to biologic mesh) and the follow-up rate was 92% at 2 years. Compared with biologic mesh, synthetic mesh significantly reduced the risk of hernia recurrence (hazard ratio, 0.31; 95% CI, 0.23-0.42; P < .001). The overall intent-to-treat hernia recurrence risk at 2 years was 13% (33 of 253 patients). Recurrence risk with biologic mesh was 20.5% (26 of 127 patients) and with synthetic mesh was 5.6% (7 of 126 patients), with an absolute risk reduction of 14.9% with the use of synthetic mesh (95% CI, -23.8% to -6.1%; P = .001). There was no significant difference in overall 2-year risk of surgical site occurrence requiring a procedural intervention between the groups (odds ratio, 1.22; 95% CI, 0.60-2.44; P = .58). Median (IQR) 30-day hospital direct costs were significantly greater in the biologic group vs the synthetic group ($44 936 [$35 877-$52 656] vs $17 289 [$14 643-$22 901], respectively; P < .001). There was also a significant difference in the price of the prosthetic device between the 2 groups (median [IQR] cost biologic, $21 539 [$20 285-$23 332] vs synthetic, $105 [$105-$118]; P < .001). CONCLUSIONS AND RELEVANCE: Synthetic mesh demonstrated superior 2-year hernia recurrence risk compared with biologic mesh in patients undergoing single-stage repair of contaminated ventral hernias, and both meshes demonstrated similar safety profiles. The price of biologic mesh was over 200 times that of synthetic mesh for these outcomes. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02451176.

The Efficacy of Liposomal Bupivacaine on Postoperative Pain Following Abdominal Wall Reconstruction: A Randomized, Double-blind, Placebo-controlled Trial.

OBJECTIVE: To study the efficacy of liposomal bupivacaine on postoperative opioid requirement and pain following abdominal wall reconstruction. SUMMARY BACKGROUND DATA: Despite the widespread use of liposomal bupivacaine in transversus abdominis plane block, there is inadequate evidence demonstrating its efficacy in open abdominal wall reconstruction. We hypothesized that liposomal bupivacaine plane block would result in decreased opioid requirements compared with placebo in the first 72 hours after surgery. METHODS: This was a single-center double-blind, placebo-controlled prospective study conducted between July 2018 and November 2019. Adult patients (at least 18 yrs of age) undergoing open, elective, ventral hernia repairs with mesh placed in the retromuscular position were enrolled. Patients were randomized to surgeon-performed transversus abdominis plane block with liposomal bupivacaine, simple bupivacaine, or normal saline (placebo). The main outcome was opioid requirements in the first 72 hours after surgery. Secondary outcomes included total inpatient opioid use, pain scores determined using a 100 mm visual analog scale, length of hospital stay, and patientreported quality of life. RESULTS: Of the 164 patients who were included in the analysis, 57 patients received liposomal bupivacaine, 55 patients received simple bupivacaine, and 52 received placebo. There were no differences in the total opioid used in the first 72 hours after surgery as measured by morphine milligram equivalents when liposomal bupivacaine was compared with simple bupivacaine and placebo (325 ± 225 vs 350 ± 284 vs 310 ± 272, respectively, P = 0.725). Similarly, there were no differences in total inpatient opioid use, pain scores, length of stay, and patient-reported quality of life. CONCLUSIONS: There are no apparent clinical benefits to using liposomal bupivacaine transversus abdominis plane block when compared with simple bupivacaine and placebo for open abdominal wall reconstruction.

Endoscopic pancreatic function test using combined secretin and cholecystokinin stimulation for the evaluation of chronic pancreatitis.

BACKGROUND: Current endoscopic pancreatic function test (ePFT) methods use either secretin or cholecystokinin (CCK) to measure pancreatic function. OBJECTIVE: To evaluate a novel ePFT protocol that includes both secretin and CCK stimulation and to assess which fluid parameters best discriminate patients with chronic pancreatitis (CP). DESIGN: Prospective, cross-sectional diagnostic study. SETTING: Single, tertiary-care institution. PATIENTS: Healthy volunteers and patients evaluated for CP were included. INTERVENTIONS: All patients underwent a combined secretin-CCK ePFT. Patients evaluated for CP also underwent EUS during the same endoscopic session. MAIN OUTCOME MEASUREMENTS: Duodenal fluid bicarbonate, lipase, and amylase concentrations were measured after CCK and secretin stimulation. Results were compared based on the presence of CP detected by EUS (≥5 features). RESULTS: Twenty healthy volunteers and 69 patients evaluated for CP completed the secretin and CCK ePFT. Patients with an EUS score of 5 or higher had significantly decreased peak bicarbonate concentrations (72 mmol) compared with patients with an EUS score lower than 5 (90 mmol) and healthy subjects (108 mmol) (P < .001). Peak concentrations of amylase and lipase and total fluid volume were not significantly different between patients with CP and controls. Receiver-operating characteristic analysis revealed that peak bicarbonate concentration had superior discrimination for CP (area under the curve [AUC] 0.738) compared with peak amylase (AUC 0.677) and peak lipase (AUC 0.627). The addition of enzyme concentration measurement did not improve discrimination compared with peak bicarbonate alone. LIMITATIONS: Secretin and cholecystokinin endoscopic pancreatic function test (SC ePFT) results were not compared with those of single hormone ePFTs. CONCLUSIONS: The addition of CCK infusion and enzyme concentration measurement to a standard secretin ePFT does not enhance the diagnosis of CP.

Adding triamcinolone to endoscopic ultrasound-guided celiac plexus blockade does not reduce pain in patients with chronic pancreatitis.

BACKGROUND & AIMS: The efficacy of endoscopic ultrasound-guided celiac plexus blockade (EUS-CPB) for painful chronic pancreatitis (CP) is uncertain. Triamcinolone is often mixed with bupivacaine to lengthen the analgesic effect. We investigated whether addition of triamcinolone increases and lengthens pain relief compared with EUS-CPB with only bupivacaine. METHODS: We performed a single-center, blinded, randomized, controlled trial of 40 adult patients referred for EUS-CPB for treatment of painful CP. Patients were assigned randomly to groups that received EUS-CPB with triamcinolone and bupivacaine or EUS-CPB with only bupivacaine (control). Questionnaires were collected when the study began (baseline) and 1 month later. The primary end point was a decrease in the pain disability index of 10 or more points at 1 month after the procedure. Secondary end points included change in visual analogue scale, narcotic requirements, and quality of life at 1 month. RESULTS: There were no significant differences in primary outcomes between groups (14.3% for patients who received triamcinolone vs 15.8% for controls; P = .64). The trial was stopped for futility. There was no significant difference between groups in immediate response rates (85.7% for patients who received triamcinolone vs 68.4% for control; P = .10), or other secondary end points, including change in pain visual analogue scale (0.4 vs 1.0; P = .83), treatment with morphine equivalents at 1 month (-7.8 vs 0.0; P = .35), change in quality of life at 1 month (SF-12 mental component: 1.3 vs -2.1; P = .44; and physical component: -0.2 vs 1.7; P = .54), or adverse events. The duration of response was shorter in the triamcinolone group (mean, 5.3 vs 0.6 mo; P = .01). CONCLUSIONS: Triamcinolone does not increase pain relief or lengthen the effects of EUS-CPB.