Body morphometry may predict parastomal hernia following radical cystectomy with ileal conduit.

OBJECTIVE: To investigate whether preoperative body morphometry analysis can identify patients at risk of parastomal hernia (PH), which is a common complication after radical cystectomy (RC). PATIENTS AND METHODS: All patients who underwent RC between 2010 and 2020 with available cross-sectional imaging preoperatively and at 1 and 2 years postoperatively were included. Skeletal muscle mass and total fat mass (FM) were determined from preoperative axial computed tomography images obtained at the level of the L3 vertebral body using Aquarius Intuition software. Sarcopenia and obesity were assigned based on consensus definitions of skeletal muscle index (SMI) and FM index (FMI). PH were graded using both the Moreno-Matias and European Hernia Society criteria. Binary logistic regression and recursive partitioning were used to identify patients at risk of PH. The Kaplan-Meier method with log-rank and Cox proportional hazards models included clinical and image-based parameters to identify predictors of PH-free survival. RESULTS: A total of 367 patients were included in the final analysis, with 159 (43%) developing a PH. When utilising binary logistic regression, high FMI (odds ratio [OR] 1.63, P < 0.001) and low SMI (OR 0.96, P = 0.039) were primary drivers of risk of PH. A simplified model that only relied upon FMI, SMI, and preoperative albumin improved the classification of patients at risk of PH. On Kaplan-Meier analysis, patients who were obese or obese and sarcopenic had significantly worse PH-free survival (P < 0.001). CONCLUSION: Body morphometry analysis identified FMI and SMI to be the most consistent predictors of PH after RC.

Short-term outcomes of heavyweight versus mediumweight synthetic mesh in a retrospective cohort of clean-contaminated and contaminated retromuscular ventral hernia repairs.

BACKGROUND: Mediumweight (40-60 g/m2) polypropylene (MWPP) mesh has been shown to be safe and effective in CDC class II-III retromuscular ventral hernia repairs (RMVHR). However, MWPP has the potential to fracture, and it is possible that heavyweight (> 75 g/m2) polypropylene mesh has similar outcomes in this context. However, there is limited data on HWPP mesh performance in clean-contaminated and contaminated scenarios. We aimed to compare HWPP to MWPP mesh in CDC class II-III wounds during open RMVHR. METHODS: The Abdominal Core Health Quality Collaborative database was retrospectively queried for a cohort of patients who underwent open RMVHR with MWPP or HWPP mesh placed in CDC class II/III wounds from 2012 to 2023. Mesh types were compared using a 3:1 propensity score-matched analysis. Covariates for matching included CDC classification, BMI, diabetes, smoking within 1 year, hernia, and mesh width. Primary outcome of interest included wound complications. Secondary outcomes included reoperations and readmissions at 30 days. RESULTS: A total of 1496 patients received MWPP or HWPP (1378 vs. 118, respectively) in contaminated RMVHR. After propensity score matching, 351 patients remained in the mediumweight and 117 in the heavyweight mesh group. There were no significant differences in surgical site infection (SSI) rates (13.4% vs. 14.5%, p = 0.877), including deep SSIs (0.3% vs. 0%, p = 1), surgical site occurrence rates (17.9% vs. 22.2%, p = 0.377), surgical site occurrence requiring procedural intervention (16% vs. 17.9%, p = 0.719), mesh removal (0.3% vs. 0%, p = 1), reoperations (4.6% vs. 2.6%, p = 0.428), or readmissions (12.3% vs. 9.4%, p = 0.504) at 30 days. CONCLUSION: HWPP mesh was not associated with increased wound morbidity, mesh excisions, reoperations, or readmissions in the early postoperative period compared with MWPP mesh in open RMVHR for CDC II/III cases. Longer follow-up will be necessary to determine if HWPP mesh may be a suitable alternative to MWPP mesh in contaminated scenarios.

Long-term mesh-related complications from minimally invasive intraperitoneal onlay mesh for small to medium-sized ventral hernias.

INTRODUCTION: Intraperitoneal onlay mesh (IPOM) placement for small to medium-sized hernias has garnered negative attention due to perceived long-term risk of mesh-related complications. However, sparse data exists supporting such claims after minimally invasive (MIS) IPOM repairs and most is hindered by the lack of long-term follow-up. We sought to report long-term outcomes and mesh-related complications of MIS IPOM ventral hernia repairs. METHODS AND PROCEDURES: Adult patients who underwent MIS IPOM ventral hernia repair at our institution were identified in the Abdominal Core Health Quality Collaborative database from October 2013 to October 2020. Outcomes included hernia recurrence and mesh-related complications or reoperations up to 6 years postoperatively. RESULTS: A total of 325 patients were identified. The majority (97.2%) of cases were elective, non-recurrent (74.5%), and CDC class I (99.4%). Mean hernia width was 4.16 ± 3.86 cm. Median follow-up was 3.6 (IQR 2.8-5) years. Surgeon-entered or patient-reported follow-up was available for 253 (77.8%) patients at 3 years or greater postoperatively. One patient experienced an early small bowel obstruction and was reoperated on within 30 days. Two-hundred forty-five radiographic examinations were available up to 6 years postoperatively. Twenty-seven patients had hernia recurrence on radiographic examination up to 6 years postoperatively. During long-term follow-up, two mesh-related complications required reoperations: mesh removed for chronic pain and mesh removal at the time of colon surgery for perforated cancer. Sixteen additional patients required reoperation within 6 years for the following reasons: hernia recurrence (n = 5), unrelated intraabdominal pathology (n = 9), obstructed port site hernia (n = 1), and adhesive bowel obstruction unrelated to the prosthesis (n = 1). The rate of reoperation due to intraperitoneal mesh complications was 0.62% (2/325) with up to 6 year follow-up. CONCLUSION: Intraperitoneal mesh for repair of small to medium-sized hernias has an extremely low rate of long-term mesh-related complications. It remains a safe and durable option for hernia surgeons.

The association of permanent versus absorbable fixation on developing chronic post-herniorrhaphy groin pain in patients undergoing laparoscopic inguinal hernia repair.

INTRODUCTION: Fixation of mesh during minimally invasive inguinal hernia repair is thought to contribute to chronic post-herniorrhaphy groin pain (CGP). In contrast to permanent tacks, absorbable tacks are hypothesized to minimize the likelihood of CGP. This study aimed to compare the rates of CGP after laparoscopic inguinal hernia repair between absorbable versus permanent fixation at maximum follow-up. METHODS: This is a post hoc analysis of a randomized controlled trial in patients undergoing laparoscopic inguinal hernia repair (NCT03835351). All patients were contacted at maximum follow-up after surgery to administer EuraHS quality of life (QoL) surveys. The pain and restriction of activity subdomains of the survey were utilized. The primary outcome was rate of CGP, as defined by a EuraHS QoL pain domain score ≥ 4 measured at ≥ 1 year postoperatively. The secondary outcomes were pain and restriction of activity domain scores and hernia recurrence at maximum follow-up. RESULTS: A total of 338 patients were contacted at a mean follow-up of 28 ± 11 months. 181 patients received permanent tacks and 157 patients received absorbable tacks during their repair. At maximum follow-up, the rates of CGP (27 [15%] vs 28 [18%], P = 0.47), average pain scores (1.78 ± 4.38 vs 2.32 ± 5.40, P = 0.22), restriction of activity scores (1.39 ± 4.32 vs 2.48 ± 7.45, P = 0.18), and the number of patients who reported an inguinal bulge (18 [9.9%] vs 15 [9.5%], P = 0.9) were similar between patients with permanent versus absorbable tacks. On multivariable analysis, there was no significant difference in the odds of CGP between the two groups (OR 1.23, 95% CI [0.60, 2.50]). CONCLUSION: Mesh fixation with permanent tacks does not appear to increase the risk of CGP after laparoscopic inguinal hernia repair when compared to fixation with absorbable tacks. Prospective trials are needed to further evaluate this relationship.

Long-term Clinical and Patient-Reported Outcomes After Transversus Abdominis Release With Permanent Synthetic Mesh: A Single Center Analysis of 1203 Patients.

OBJECTIVE: We aimed to report long-term clinical and patient-reported outcomes of transversus abdominis release (TAR) with permanent synthetic mesh performed in a high-volume abdominal wall reconstruction practice. SUMMARY BACKGROUND DATA: Despite increasing utilization of TAR in abdominal wall reconstruction, long-term clinical and patient-reported outcomes remain uncertain. METHODS: Prospectively collected registry data from the Cleveland Clinic Center for Abdominal Core Health were analyzed retrospectively. Patients undergoing elective, open VHR with TAR and permanent synthetic mesh implantation between August 2014 and March 2020 with 30-day clinical and ≥1 year clinical or patient-reported outcome follow-up were included. Outcomes included composite hernia recurrence, characterized by patient-reported bulges and recurrent hernias noted on physical exam or imaging, as well as hernia-specific quality of life and pain. RESULTS: A total of 1203 patients were included. Median age was 60 years [interquartile range (IQR): 52-67], median body mass index was 32 kg/m 2 (IQR: 28-36), median hernia width was 15 cm (IQR: 12-19), and 57% of hernias were recurrent. Fascial reapproximation was achieved in 92%. At a median follow-up of 2 years (IQR: 1-4), the overall composite hernia recurrence rate was 26%, with sensitivity analysis yielding best-case and worst-case estimates of 5% and 28%, respectively. Patients experienced improved hernia-specific quality of life and pain regardless of recurrence outcome; however, those who did not recur experienced more substantial improvement. CONCLUSIONS: TAR with permanent synthetic mesh remains a valuable, versatile technique; however, surgeon and patient expectations should be tempered regarding long-term durability. Despite a high rate of recurrence, patients experience measurable improvements in quality of life.

Injuries incurred from minimally invasive access for abdominal surgery.

BACKGROUND: Injuries during initial port placement in minimally invasive abdominal surgery are rare but can cause major morbidity. We aimed to characterize the incidence, consequence, and risk factors for injury occurring on initial port placement. METHODS: This is a retrospective review of a General Surgery quality collaborative database with supplementary input from the Morbidity and Mortality conference database at our institution between 6/25/2018 and 6/30/2022. Patient characteristics, operative details, and postoperative course were assessed. Cases with an injury on entry were compared to cases without an injury to identify risk factors for injury. RESULTS: 8844 minimally invasive cases were present between the two databases. Thirty-four injuries (0.38%) occurred during initial port placement. Seventy-one percent of injuries were bowel injuries (full or partial thickness) and the majority (79%) of injuries were recognized during the index operation. Median surgeon experience for the cases with an injury was 9 years (IQR 4.25-14.5) compared to 12 years of experience for all surgeons contributing to the database (p = 0.004). Previous laparotomy was also significantly correlated with the rate of injury on entry (p = 0.012). There was no significant difference in the rate of injury based on method of entry (cut-down: 19 (55.9%), optical entry without Veress: 10 (29.4%), Veress followed by optical entry: 5 (14.7%), p = 0.11). BMI > 30 kg/m2 (injury: 16/34 vs no injury: 2538/8844, p = 0.847) was not associated with an injury. Fifty-six percent (19/34) of patients with an injury on initial port placement required laparotomy at some point in their hospital course. CONCLUSIONS: Injuries are rare during initial port placement for minimally invasive abdominal surgery. In our database, history of a previous laparotomy was a significant risk factor for an injury and appears to be more consequential than commonly implicated factors such as technique, patient body habitus, or surgeon experience.

Surgical approaches for core abdominal injuries: a review of the Abdominal Core Health Quality Collaborative database.

INTRODUCTION: Core abdominal injury (CAI) is a broad term that describes injuries resulting from repetitive loading of the pubis that leads to inflammation, rupture, or destabilization of the core muscles from the pubic bone. There is no clear recommendation on the surgical approach to CAI. We aimed to describe how hernia surgeons within the Abdominal Core Health Quality Collaborative (ACHQC) address this problem surgically and the short-term outcomes. METHODS: We queried the ACHQC registry for patients undergoing surgery for isolated CAI and concomitant inguinal hernias (IH) and CAI. Operative approach and quality of life (using EuraHS survey scores) was abstracted. RESULTS: A total of 29,451 patients underwent surgery for IHs, CAIs, or both within the registry. Twenty patients underwent surgery for isolated CAI (median age 29, 90% males). Eleven patients (55%) underwent surgery with mesh (four Lichtenstein, three TAPP, and four TEP). Nine patients (45%) underwent tissue-based repairs (four closure of floor, one Bassini, one McVay, one Shouldice, one femoral exploration, and one laparoscopic-to-open conversion). There were no postoperative complications or reoperations within 30 days. EuraHS scores showed improvement at 30 days from baseline (median 29 [6.75-41.75] from 42 [29.42-57.61]). Sixty patients had both IHs and CAIs (median age 31, 97% males). All patients received mesh. Thirty-one patients (52%) underwent open surgery (23 Lichtenstein, 1 plug, 7 TREPP) and 29 underwent minimally invasive repairs (23 TAPP, 6 TEP). There was one seroma at 30 days. EuraHS scores showed improvement at 30 days from baseline (median 16 [5.17-27.33] from 37.5 [26.44-46.58]). CONCLUSIONS: Despite technical variability, CAIs with or without concomitant IH generally undergo operations commonly used for IH repairs. Within our series, there was inconsistency with approach and mesh placement. Future work should be focused on standardizing the approach to CAI and capturing long-term data within the ACHQC.

Mediumweight polypropylene mesh fractures after open retromuscular ventral hernia repair: incidence and associated risk factors.

PURPOSE: Mediumweight (MW) and heavyweight (HW) polypropylene have demonstrated similar clinical and patient-reported outcomes in the setting of open retromuscular ventral hernia repair (VHR). While MW mesh has an anecdotal risk of central mesh fracture, that phenomenon is not well-characterized. We sought to assess the incidence of and risk factors for MW polypropylene mesh fractures after VHR. METHODS: The ACHQC registry was queried for patients with CT-documented hernia recurrence after open retromuscular VHR with MW polypropylene mesh at our institution with 1-year follow-up between January 2014 and April 2022. Images were reviewed by five blinded surgeons at Cleveland Clinic to reach consensus that hernia recurrence mechanism was central mesh fracture. Patients without clinical recurrence or patient-reported bulge were used as a comparator group. RESULTS: Eighty patients were identified with radiographically documented recurrence; 28 had recurrence from mesh fractures and these were compared to 644 patients without recurrence. Incidence of MW fracture was 4.2%. Bridging of anterior fascia was more common in the group with the central mesh fracture (33.3% vs 3.3%, p < 0.001); the incidence of fracture was 30% (9/30) in patients requiring a bridged closure. Mesh fracture was associated with larger hernias (median width: 20 cm [16-26] vs 15 cm [12-18], p < 0.001,), length (25 cm [23-30] vs 23 cm [19-26], p = 0.004). CONCLUSION: MW polypropylene mechanical failures are surprisingly common, particularly in settings of bridged fascial closure and larger hernias. Use of HW polypropylene should be considered in this setting, and industry should be encouraged to create larger pieces of HW polypropylene mesh.

Single-staged retromuscular abdominal wall reconstruction with mesh at the time of ostomy reversal: are we crossing the line? An ACHQC Analysis.

INTRODUCTION: The most appropriate method of reconstructing the abdominal wall at the site of a simultaneous stoma takedown is controversial. The contaminated field, concomitant GI procedure being performed and presence of a hernia all complicate decision-making. We sought to describe the surgical approaches, mesh type and outcomes of concomitant abdominal wall reconstruction during stoma takedown in a large hernia registry. METHODS AND PROCEDURES: All patients who underwent stoma takedown with simultaneous hernia repair with retromuscular mesh placement from January 2014 to May 2022 were identified within the Abdominal Core Health Quality Collaborative (ACHQC). Patients were stratified by mesh type including permanent synthetic (PS), resorbable synthetic (RS) and biologic mesh. Association of mesh type with 30-day wound events and other complications and 1-year outcomes were evaluated. RESULTS: There were 368 patients who met inclusion criteria. Eighty-nine patients had ileostomies, 276 colostomies and 3 had both. Two hundred and seventy-nine (75.8%) patients received PS mesh, 46 (12.5%) biologic, and 43 (11.7%) RS. Seventy percent (259/368) had a parastomal hernia, 75% (285/368) had a midline incisional hernia, and 48% (178/368) had both. All groups had similar preoperative comorbidities and the majority had a transversus abdominus release. All mesh groups had similar thirty-day SSI (13.2-14.3%), SSO (10.5-17.8%) and SSOPI (7.9-14.1%), p = 0.6. Three patients with PS mesh developed infected synthetic mesh and one PS mesh required excision. Four patients with PS developed an enterocutaneous fistula. Of these, only one patient was recorded as having both an enterocutaneous fistula and mesh infection. Thirty-day reoperation and readmission were similar across all mesh groups. Recurrence at 1-year was similar between mesh groups. Quality of life measured using HerQLes scores were higher at one year compared to baseline in all groups indicating improvement in hernia-specific quality of life. CONCLUSION: Early complication rates associated with simultaneous stoma takedown and abdominal wall reconstruction are significant, regardless of mesh type utilized. Concomitant surgery should be weighed heavily and tailored to individual patients.

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.

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.

Clinical and surgical outcomes of splenectomy for autoimmune hemolytic anemia.

INTRODUCTION: We investigated short and long-term remission rates after splenectomy in patients with primary and secondary autoimmune hemolytic anemia (AIHA). METHODS: All adults who underwent splenectomy for primary or secondary AIHA at a single center (2004-2018) were retrospectively reviewed. Short-term response was determined at 30-day postoperatively and long-term at one year. Complete response was defined as hemoglobin > 10 g/dL without hemolysis, transfusions, or need for additional medical therapy for > 6 months. RESULTS: Short-term complete response was attained in 22 of 36 patients (61%), partial response in 3 (8%), no response in 11 (31%). The response rate at 1 year was complete in 14/36 (39%), partial in 14 (39%), and 8 non-response (22%). At last available follow-up (median 33.1 months (IQR 19-59), 16/37 patients had experienced a complete response (43%), 14 partial response (38%), 7 non-response (19%). 80% of partial responders with primary AIHA required maintenance therapy compared to 100% with secondary AIHA. CONCLUSION: Splenectomy is associated with short- and long-term improvement in anemia and hemolysis in the majority of patients with AIHA. Immunosuppressants remain important supplemental therapy.

Registry-Based Trainee Assessments: Leveraging a Quality Collaborative for Surgical Education.

INTRODUCTION: We present our experience developing and embedding a registry-based module for resident feedback. METHODS: At our institution, entering operative data into the institutional quality collaborative registry is standard practice. In February 2019, a surgical education module was embedded into the registry to capture procedure-specific resident operative assessments. Faculty engagement with the sugical education module was assessed during its first year in existence (February 2019-February 2020). RESULTS: In total, 1074 of 1269 (85%) operative assessments were completed by 27 faculty via the surgical education registry module. Median faculty engagement rate with the module following resident-assisted procedures was 91% [IQR 76%-100%]. Residents received a median of 7 operative assessments [IQR 2-19] over the study period. CONCLUSION: By embedding a surgical education module into an existing surgical quality collaborative registry, procedure-specific operative assessments can be routinely captured.

Effect modification of resident autonomy and seniority on perioperative outcomes in laparoscopic cholecystectomy.

BACKGROUND: Resident operative involvement is an integral aspect of general surgery residency training. However, current data examining the effect of resident autonomy on perioperative outcomes remain limited. METHODS: Patient and operator-specific data were collected from 344 adult laparoscopic cholecystectomies at a tertiary academic institution and its regional affiliates between 2018 and 2019. Multivariate modeling compared postoperative outcomes between cases completed with or without resident involvement and its effect modification by resident seniority and autonomy per Zwisch scale. Outcomes include 30-day postoperative complications, hospital readmission rate, and operative time. RESULTS: Multivariate analysis revealed resident involvement in laparoscopic cholecystectomy did not significantly change odds of 30-day postoperative complications (OR 2.52, p = 0.185, 95% CI 0.64-9.92) or hospital readmission (OR 1.61, p = 0.538, 95% CI 0.36-7.23). Operative time is significantly increased compared to faculty-only cases (IRR 1.37, p < 0.001, 95% CI 1.26-1.48). While accounting for case difficulty and resident performance evaluated by SIMPL criteria, stratification by resident autonomy measured by Zwisch scale or seniority reveal no effect modification on 30-day postoperative complications, readmissions, or operative time. The effect of resident involvement on longer relative rates of operative time loses its significance in supervision-only cases (IRR 1.18, p = 0.069, 95% CI 0.99-1.41). CONCLUSION: While resident involvement and autonomy are associated with significantly longer operative times in laparoscopic cholecystectomy, their lack of significant effect on postoperative outcomes argues strongly for continued resident involvement and supervised operative independence.

Registry-Based Randomized Controlled Trials: A New Paradigm for Surgical Research.

BACKGROUND: Randomized controlled trials (RCTs) are the gold standard to establish evidence for surgical practice but can be hindered by high costs, complexity, and time requirements. Recently, observational registries have been leveraged as platforms for clinical trials to address these limitations, though few registry-based surgical RCTs have been conducted. Here, we present our group's approach to surgical registry-based RCTs and early results. MATERIALS AND METHODS: To facilitate these trials, we focused on registry integration into surgeons' workflows, routine collection of patient-reported outcomes at clinic visits, and pragmatic trial design featuring broad inclusion criteria and standard of care follow-up. These features maximize generalizability and facilitate follow-up by minimizing visits and tests outside of normal practice. RESULTS: Since 2017, our group has completed enrollment in 4 registry-based RCTs with another 5 trials ongoing. Of these, 4 trials have been multicenter. Over 1000 patients have been enrolled in these studies, with follow-up rates of 90% or greater. Most of these trials are on track to complete enrollment in approximately 2 y from their start date. Beyond salary support, resource utilization is low. None of our trials has been terminated due to lack of resources or futility. CONCLUSIONS: Registry-based RCTs allow for efficient conduct of pragmatic surgical trials. Thoughtful study design, registry integration into surgeons' routines, and a team culture embracing research are paramount. We believe registry-based trials are the future of affordable, high-level, prospective surgical research.

Correction to: Bariatric efficiency at an academic tertiary care center.

This article was updated to correct Adel Alhaj Saleh's name, incorrectly displayed as Adel A. Saleh. It is correct as displayed here: Adel (first name) Alhaj Saleh (last name).

Bariatric efficiency at an academic tertiary care center.

BACKGROUND: Operating room (OR) efficiency requires coordinated teamwork between the staff surgeon, anesthesia team, circulating nurse, surgical technician, and surgical trainee or assistant. Bariatric cases present unique challenges including difficult airways, challenging intravenous access, use of specialized surgical equipment, and synchronized exchange of orogastric tubes. The high contribution margin of these complex bariatric procedures rests on OR efficiency. OBJECTIVE: To compare the efficiency of bariatric surgeries performed by a single surgeon at a tertiary academic medical center with its inherent variability of OR staff to that of a private hospital with a standardized surgical team. METHODS: All laparoscopic Roux-en-Y gastric bypasses (LRYGB) performed by a single surgeon at University Hospitals Cleveland Medical Center (UHCMC) and a Community Affiliate (CA) from 2013 to 2015 were retrospectively reviewed. Patient demographics and preoperative comorbidities were compared. The variability of OR staff at each site was described. Four primary endpoints of the different OR phases were measured at the 2 locations and analyzed using standard statistical methods. RESULTS: The OR data of 74 cases of LRYGB at UHCMC and 106 cases at the CA were analyzed. Patient cohorts were comparable by age (45 ± 12 vs. 45 ± 10; p = 0.88), sex (82% vs. 79% female; p = 0.62), BMI (47.16 ± 7.33 vs. 45.91 ± 6.85; p = 0.25), and comorbidities. At CA, the teams who participated in LRYGB cases were fairly constant (8 circulating and scrub nurses, 4 anesthetists, 3 anesthesiologists), whereas at UHCMC there was great variability in the number of staff with 108 staff (39 circulating nurses, 57 scrub nurses/technicians, 59 anesthetists or anesthesia residents, 24 anesthesiologists) participated in LRYGB cases. There was no statistical difference between the total mean OR time and surgical time of the cases performed at the 2 sites (203 ± 59 min vs. 188 ± 39 min; p = 0.06; 152 ± 56 min; 145 ± 37 min; p = 0.36). However, the pre- and post-case times were longer at UHCMC compared to the CA (38 ± 9 min vs. 33 ± 6 min; p < 0.0001; 13 ± 6 min vs. 10 ± 3 min; p = 0.01). CONCLUSION: The academic center has much greater variability in staff for these complex bariatric procedures. There was a trend toward longer OR times at the tertiary center as demonstrated by the difference in pre- and post-case times, but the consistent surgeon and assistant allowed for consistent surgical case time regardless of the setting. The implication of variability in OR staff can be overcome by the surgeon directing the procedure itself. The opportunity for improving the efficiency of bariatric surgery should focus on the perioperative care of the patient in OR that requires everyone to be familiar with the procedure.

The Diagnostic Utility of Splenectomy in Idiopathic Splenomegaly.

INTRODUCTION: With increasing frequency, patients with idiopathic splenomegaly are referred to surgeons for splenectomy. We evaluated the diagnostic utility of splenectomy and feasibility of a minimally invasive approach in the face of idiopathic splenomegaly. METHODS: We retrospectively reviewed 68 patients who underwent splenectomy for idiopathic splenomegaly. The primary endpoint was the rate of definitive diagnosis based on final surgical pathology of the removed spleen. RESULTS: Preoperative workup included a bone marrow biopsy and peripheral blood smear in 93% and 100% of patients, respectively, with none having lymphadenopathy warranting biopsy. Splenectomy provided a definitive diagnosis for 44 (64.7%) patients. Of these, 34 (50%) patients had an underlying malignancy, of which more than half were splenic marginal zone lymphoma. There were 33 (48.5%) laparoscopic, 23 (33.8%) open, 10 (14.7%) laparoscopic converted to open, and two (2.9%) laparoscopic hand-assist cases. Conversion to open was due to splenic size [median craniocaudal length 21.8 cm (cm)] in eight and staple line bleeding at the splenic hilum in two patients. Overall, the laparoscopic approach was completed in patients with a smaller splenic size compared to open (median craniocaudal length 15.2 vs. 26.0 cm, p < 0.0001). The open group had one (1.5%) intra-operative mortality due to uncontrollable hemorrhage. Thirty-day complication rates were similar for laparoscopic and open approaches (p = 0.10). CONCLUSION: Splenectomy is an effective diagnostic modality in determining a pathologic cause for splenomegaly in this patient population. Laparoscopic splenectomy can be performed safely in appropriate cases with craniocaudal splenic size having the largest influence on surgical approach.

Laparoscopic splenectomy for immune thrombocytopenia (ITP): long-term outcomes of a modern cohort.

BACKGROUND: The advent of newer second-line medical therapies (SLMT) for immune thrombocytopenia (ITP) has contributed to decreased rates of splenectomy, following a trend to avoid or delay surgery. We aimed to characterize the long-term outcomes of laparoscopic splenectomy (LS) for ITP at our institution, examining differences in LS efficiency when performed before or after SLMTs. METHODS: Adults with primary ITP who underwent LS between 2002 and 2016 were identified. Retrospective review of electronic medical records was supplemented with telephone interviews. Treatment response was defined according to current guidelines as complete responders (CR), responders (R), and non-responders (NR). Kaplan-Meier estimates assessed relapse-free rates, and predictors of long-term response were investigated using logistic regression. RESULTS: 109 patients met inclusion criteria, from which 42% were treated with an SLMT before referral to LS. LS was completed in all cases, with no conversions or intraoperative complications. The perioperative morbidity was 7.3%, including 3 deep vein and 2 portal vein thrombosis, one reoperation for bleeding, and no mortalities. Splenectomy was initially effective in 99 patients (CR + R = 90.8%), and 10 patients were NR. At a median 62-month follow-up, 25 patients relapsed, resulting in a 68% CR + R rate. Proportion of CR + R was similar in patients who previously received SLMT and those who did not (61 vs. 76.7%, p = 0.08). CR + R patients were younger (45 vs. 53, p = 0.03), had higher preoperative platelet counts (36 vs. 19, p = 0.01), and experienced a higher increment in platelet counts during hospital stay (117 vs. 38, p < 0.001) as well as 30-days postoperatively (329 vs. 124, p < 0.001). Only a robust response in platelet count at 30-days postoperatively was independently associated with long-term response (OR 1.005, p = 0.006). CONCLUSION: LS was curative in 68% of patients, with no statistically significant difference when performed before or after SLMTs. Outcomes remain challenging to predict preoperatively, with only a robust increase in platelet counts on short term being associated with long-term response.