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1.
Hernia ; 2024 Jun 18.
Article En | MEDLINE | ID: mdl-38890182

PURPOSE: Although intraoperative music is purported to mitigate postoperative pain after some procedures, its application has never been explored in abdominal wall reconstruction (AWR). We sought to determine whether intraoperative music would decrease early postoperative pain following AWR. METHODS: We conducted a placebo-controlled, patient-, surgeon-, and assessor-blinded, randomized controlled trial at a single center between June 2022 and July 2023 including 321 adult patients undergoing open AWR with retromuscular mesh. Patients received noise-canceling headphones and were randomized 1:1 to patient-selected music or silence after induction, stratified by preoperative chronic opioid use. All patients received multimodal pain control. The primary outcome was pain (NRS-11) at 24 ± 3 h. The primary outcome was analyzed by linear regression with pre-specified covariates (chronic opioid use, hernia width, operative time, myofascial release, anxiety disorder diagnosis, and preoperative STAI-6 score). RESULTS: 178 patients were randomized to music, 164 of which were analyzed. 177 were randomized to silence, 157 of which were analyzed. At 24 ± 3 h postoperatively, there was no difference in the primary outcome of NRS-11 scores (5.18 ± 2.62 vs 5.27 ± 2.46, p = 0.75). After adjusting for prespecified covariates, the difference of NRS-11 scores at 24 ± 3 h between the music and silence groups remained insignificant (p = 0.83). There was no difference in NRS-11 or STAI-6 scores at 48 ± 3 and 72 ± 3 h, intraoperative sedation, or postoperative narcotic usage. CONCLUSION: For patients undergoing AWR, there was no benefit of intraoperative music over routine multimodal pain control for early postoperative pain reduction. TRIAL REGISTRATION: ClinicalTrials.gov: NCT05374096.

2.
Surg Endosc ; 2024 Jun 11.
Article En | MEDLINE | ID: mdl-38862822

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.

3.
JAMA Surg ; 2024 Jun 12.
Article En | MEDLINE | ID: mdl-38865142

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.

4.
Hernia ; 2024 Jun 18.
Article En | MEDLINE | ID: mdl-38888837

PURPOSE: The Ventral Hernia Working Group (VHWG) proposed a ventral hernia grading guideline, primarily supported by expert opinion, recommending biologic mesh placement in high-risk patients. We investigated the relationship between this industry-sponsored guideline and discourse around ventral hernia repair (VHR). METHODS: Medline platform from Web of Science's database identified publications "pre-VHWG"(1999-01-01 to 2009-12-31), and "post-VHWG"(2010-01-01 to 2020-12-31) describing VHR and complications or recurrence of VHR with the following comorbidities: COPD, smoking, diabetes, immunosuppression, or obesity. Poisson regression analyzed keyword frequency over time using logarithmically transformed data. RESULTS: Of 1291 VHR publications identified pre-VHWG and 3041 publications identified post-VHWG, 172 (13.3%) and 642 (21.1%) publications respectively included prespecified keywords. The keyword groups "biologic"(IRR 3.39,95%CI1.34-11.4,p = 0.022) and "comorbid"(IRR 1.95, 95%CI1.09-3.74,p = 0.033) significantly increased with frequency after publication of the VHWG. CONCLUSION: The VHWG publication likely contributed to a focus on comorbidities and biologic mesh in the ensuing literature within the field of VHR.

5.
Surg Endosc ; 38(6): 3433-3440, 2024 Jun.
Article En | MEDLINE | ID: mdl-38710888

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.


Absorbable Implants , Chronic Pain , Groin , Hernia, Inguinal , Herniorrhaphy , Laparoscopy , Pain, Postoperative , Surgical Mesh , Humans , Hernia, Inguinal/surgery , Laparoscopy/methods , Laparoscopy/adverse effects , Herniorrhaphy/methods , Herniorrhaphy/adverse effects , Male , Pain, Postoperative/etiology , Middle Aged , Female , Groin/surgery , Chronic Pain/etiology , Aged , Quality of Life , Follow-Up Studies , Adult
6.
Inflamm Bowel Dis ; 30(Supplement_2): S39-S54, 2024 May 23.
Article En | MEDLINE | ID: mdl-38778628

Precision medicine is part of 5 focus areas of the Challenges in IBD Research 2024 research document, which also includes preclinical human IBD mechanisms, environmental triggers, novel technologies, and pragmatic clinical research. Building on Challenges in IBD Research 2019, the current Challenges aims to provide a comprehensive overview of current gaps in inflammatory bowel diseases (IBDs) research and deliver actionable approaches to address them with a focus on how these gaps can lead to advancements in interception, remission, and restoration for these diseases. The document is the result of multidisciplinary input from scientists, clinicians, patients, and funders, and represents a valuable resource for patient-centric research prioritization. In particular, the precision medicine section is focused on the main research gaps in elucidating how to bring the best care to the individual patient in IBD. Research gaps were identified in biomarker discovery and validation for predicting disease progression and choosing the most appropriate treatment for each patient. Other gaps were identified in making the best use of existing patient biosamples and clinical data, developing new technologies to analyze large datasets, and overcoming regulatory and payer hurdles to enable clinical use of biomarkers. To address these gaps, the Workgroup suggests focusing on thoroughly validating existing candidate biomarkers, using best-in-class data generation and analysis tools, and establishing cross-disciplinary teams to tackle regulatory hurdles as early as possible. Altogether, the precision medicine group recognizes the importance of bringing basic scientific biomarker discovery and translating it into the clinic to help improve the lives of IBD patients.


Precision medicine is the practice of getting the most suitable drug or treatment option to each individual patient at the right time. In Crohn's disease and ulcerative colitis, we need to learn more about the diversity of patients to deliver precision medicine.


Inflammatory Bowel Diseases , Precision Medicine , Humans , Precision Medicine/methods , Inflammatory Bowel Diseases/therapy , Biomarkers/analysis , Biomedical Research
7.
Surgery ; 176(1): 148-153, 2024 Jul.
Article En | MEDLINE | ID: mdl-38641542

BACKGROUND: Abdominal wall reconstruction requires extensive dissection of the abdominal wall, exposure of the retroperitoneum, and aggressive chemoprophylaxis to reduce the risk of thromboembolic complications. The need for early anticoagulation puts patients at risk for bleeding. We aimed to quantify postoperative blood loss, incidence of transfusion and reoperation, and associated risk factors in patients undergoing complex abdominal wall reconstruction. METHODS: All patients underwent a posterior component separation with transversus abdominis release and placement of retromuscular mesh for ventral hernias <20 cm wide and were enrolled in a clinical trial assessing the utility of trans-fascial mesh fixation. A post hoc analysis was performed to quantify postoperative hemoglobin drop, blood transfusions, and procedural interventions for ongoing bleeding during the first 30 postoperative days. Multivariate logistic regression was used to identify predictors of transfusion. RESULTS: In 325 patients, hemoglobin decreased by 3.61 (±1.58) g/dL postoperatively. Transfusion incidence was 9.5% (n = 31), and 3.1% (n = 10) required a surgical intervention for bleeding. Initiation of therapeutic anticoagulation postoperatively resulted in a higher likelihood of requiring surgical intervention for bleeding (odds ratio 10.4 [95% confidence interval 2.75-43.8], P < .01). Use of perioperative therapeutic anticoagulation was associated with higher rates of transfusion (odds ratio 3.51 [95% confidence interval 1.34-8.53], P < .01). Neither intraoperative blood loss nor operative times were associated with an increased transfusion requirement or need for operative intervention. CONCLUSION: Patients undergoing transversus abdominis release are at a high risk of postoperative bleeding that can require transfusion and reoperation. Patients requiring postoperative therapeutic anticoagulation are at particularly high risk.


Abdominal Wall , Blood Transfusion , Hernia, Ventral , Postoperative Hemorrhage , Humans , Male , Female , Middle Aged , Postoperative Hemorrhage/etiology , Postoperative Hemorrhage/epidemiology , Postoperative Hemorrhage/prevention & control , Postoperative Hemorrhage/therapy , Blood Transfusion/statistics & numerical data , Abdominal Wall/surgery , Aged , Hernia, Ventral/surgery , Surgical Mesh/adverse effects , Anticoagulants/therapeutic use , Herniorrhaphy/adverse effects , Herniorrhaphy/methods , Reoperation/statistics & numerical data , Risk Factors , Adult , Plastic Surgery Procedures/adverse effects , Plastic Surgery Procedures/methods , Incidence , Logistic Models
8.
Cancer Discov ; 14(6): 994-1017, 2024 Jun 03.
Article En | MEDLINE | ID: mdl-38593348

RAS-driven cancers comprise up to 30% of human cancers. RMC-6236 is a RAS(ON) multi-selective noncovalent inhibitor of the active, GTP-bound state of both mutant and wild-type variants of canonical RAS isoforms with broad therapeutic potential for the aforementioned unmet medical need. RMC-6236 exhibited potent anticancer activity across RAS-addicted cell lines, particularly those harboring mutations at codon 12 of KRAS. Notably, oral administration of RMC-6236 was tolerated in vivo and drove profound tumor regressions across multiple tumor types in a mouse clinical trial with KRASG12X xenograft models. Translational PK/efficacy and PK/PD modeling predicted that daily doses of 100 mg and 300 mg would achieve tumor control and objective responses, respectively, in patients with RAS-driven tumors. Consistent with this, we describe here objective responses in two patients (at 300 mg daily) with advanced KRASG12X lung and pancreatic adenocarcinoma, respectively, demonstrating the initial activity of RMC-6236 in an ongoing phase I/Ib clinical trial (NCT05379985). SIGNIFICANCE: The discovery of RMC-6236 enables the first-ever therapeutic evaluation of targeted and concurrent inhibition of canonical mutant and wild-type RAS-GTP in RAS-driven cancers. We demonstrate that broad-spectrum RAS-GTP inhibition is tolerable at exposures that induce profound tumor regressions in preclinical models of, and in patients with, such tumors. This article is featured in Selected Articles from This Issue, p. 897.


Xenograft Model Antitumor Assays , Humans , Animals , Mice , Cell Line, Tumor , Proto-Oncogene Proteins p21(ras)/genetics , Female , Antineoplastic Agents/therapeutic use , Antineoplastic Agents/pharmacology , Guanosine Triphosphate/metabolism , Neoplasms/drug therapy , Neoplasms/genetics , Neoplasms/metabolism , Lung Neoplasms/drug therapy , Lung Neoplasms/genetics , Lung Neoplasms/metabolism , Mutation , Pancreatic Neoplasms/drug therapy , Pancreatic Neoplasms/genetics , Pancreatic Neoplasms/pathology , Pancreatic Neoplasms/metabolism , Male
9.
Am J Surg ; 2024 Mar 27.
Article En | MEDLINE | ID: mdl-38580567

INTRODUCTION: Abdominal surgery following transversus abdominis release (TAR) procedure commonly involves incisions through the previously implanted mesh, potentially creating vulnerabilities for hernia recurrence. Despite the popularity of the TAR procedure, current literature regarding post-AWR surgeries is limited. This study aims to reveal the incidence and outcomes of post-TAR non-hernia-related abdominal surgeries of any kind. METHODS: Adult patients who underwent non-hernia-related abdominal surgery following ventral hernia repair with concurrent TAR procedure and permanent synthetic mesh in the Cleveland Clinic Center for Abdominal Core Health between January 2014 and January 2022 were queried from a prospectively collected database in the Abdominal Core Health Quality Collaborative. We evaluated 30-day wound morbidity, perioperative complications, and long-term hernia recurrence. RESULTS: A total of 1137 patients who underwent TAR procedure were identified, with 53 patients (4.7%) undergoing subsequent non-hernia-related abdominal surgery post-TAR. Small bowel obstruction was the primary indication for reoperation (22.6%), and bowel resection was the most frequent procedure (24.5%). 49.1% of the patients required urgent or emergent surgery, with the majority (70%) having open procedures. Fascia closure was achieved by absorbable sutures in 50.9%, and of the open cases, fascia closure was achieved by running sutures technique in 35.8%. 20.8% experienced SSO, the SSOPI rate was 11.3%, and 26.4% required more than a single reoperation. A total of 88.7% were available for extended follow-up, spanning 17-30 months, resulting in a 36.1% recurrent hernia diagnosis rate. CONCLUSIONS: Abdominal surgery following TAR surgery is associated with significant comorbidities and significantly impacts hernia recurrence rates. Our study findings underscore the significance of making all efforts to minimize reoperations after TAR procedure and offers suggestions on managing the abdominal wall of these complex cases.

10.
J Pediatr Gastroenterol Nutr ; 78(5): 1126-1134, 2024 May.
Article En | MEDLINE | ID: mdl-38482890

OBJECTIVES: Vedolizumab (VDZ) and ustekinumab (UST) are second-line treatments in pediatric patients with ulcerative colitis (UC) refractory to antitumor necrosis factor (anti-TNF) therapy. Pediatric studies comparing the effectiveness of these medications are lacking. Using a registry from ImproveCareNow (ICN), a global research network in pediatric inflammatory bowel disease, we compared the effectiveness of UST and VDZ in anti-TNF refractory UC. METHODS: We performed a propensity-score weighted regression analysis to compare corticosteroid-free clinical remission (CFCR) at 6 months from starting second-line therapy. Sensitivity analyses tested the robustness of our findings to different ways of handling missing outcome data. Secondary analyses evaluated alternative proxies of response and infection risk. RESULTS: Our cohort included 262 patients on VDZ and 74 patients on UST. At baseline, the two groups differed on their mean pediatric UC activity index (PUCAI) (p = 0.03) but were otherwise similar. At Month 6, 28.3% of patients on VDZ and 25.8% of those on UST achieved CFCR (p = 0.76). Our primary model showed no difference in CFCR (odds ratio: 0.81; 95% confidence interval [CI]: 0.41-1.59) (p = 0.54). The time to biologic discontinuation was similar in both groups (hazard ratio: 1.26; 95% CI: 0.76-2.08) (p = 0.36), with the reference group being VDZ, and we found no differences in clinical response, growth parameters, hospitalizations, surgeries, infections, or malignancy risk. Sensitivity analyses supported these findings of similar effectiveness. CONCLUSIONS: UST and VDZ are similarly effective for inducing clinical remission in anti-TNF refractory UC in pediatric patients. Providers should consider safety, tolerability, cost, and comorbidities when deciding between these therapies.


Antibodies, Monoclonal, Humanized , Colitis, Ulcerative , Gastrointestinal Agents , Ustekinumab , Humans , Colitis, Ulcerative/drug therapy , Ustekinumab/therapeutic use , Female , Male , Child , Antibodies, Monoclonal, Humanized/therapeutic use , Adolescent , Gastrointestinal Agents/therapeutic use , Treatment Outcome , Tumor Necrosis Factor-alpha/antagonists & inhibitors , Remission Induction/methods , Propensity Score , Registries
12.
Surg Endosc ; 38(4): 2019-2026, 2024 Apr.
Article En | MEDLINE | ID: mdl-38424284

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.


Digestive System Surgical Procedures , Hernia, Ventral , Incisional Hernia , Intestinal Obstruction , Laparoscopy , Adult , Humans , Surgical Mesh/adverse effects , Hernia, Ventral/surgery , Herniorrhaphy/adverse effects , Prostheses and Implants , Intestinal Obstruction/surgery , Incisional Hernia/surgery , Recurrence
13.
J Am Coll Surg ; 238(6): 1115-1120, 2024 Jun 01.
Article En | MEDLINE | ID: mdl-38372372

BACKGROUND: Ventral hernias result in fibrosis of the lateral abdominal wall muscles, increasing tension on fascial closure. Little is known about the effect of abdominal wall tension on outcomes after abdominal wall reconstruction. We aimed to identify an association between abdominal wall tension and early postoperative outcomes in patients who underwent posterior component separation (PCS) with transversus abdominis release (TAR). STUDY DESIGN: Using a proprietary, sterilizable tensiometer, the tension needed to bring the anterior fascial elements to the midline of the abdominal wall during PCS with TAR was recorded. Tensiometer measurements, in pounds (lb), were calibrated by accounting for the acceleration of Earth's gravity. Baseline fascial tension, change in fascial tension, and fascial tension at closure were evaluated with respect to 30-day outcomes, including wound morbidity, hospital readmission, reoperation, ileus, bleeding, and pulmonary complications. RESULTS: A total of 100 patients underwent bilateral abdominal wall tensiometry, for a total of 200 measurements (left and right side for each patient). Mean baseline anterior fascial tension was 6.78 lb (SD 4.55) on each side. At abdominal closure, the mean anterior fascial tension was 3.12 (SD 3.21) lb on each side. Baseline fascial tension and fascial tension after PCS with TAR at abdominal closure were not associated with surgical site infection, surgical site occurrence, readmission, ileus, and bleeding requiring transfusion. The event rates for all other complications were too infrequent for statistical analysis. CONCLUSIONS: Baseline and residual fascial tension of the anterior abdominal wall do not correlate with early postoperative morbidity in patients undergoing PCS with TAR. Further work is needed to determine if abdominal wall tension in this context is associated with long-term outcomes, such as hernia recurrence.


Abdominal Muscles , Abdominal Wall , Hernia, Ventral , Herniorrhaphy , Humans , Female , Male , Hernia, Ventral/surgery , Middle Aged , Abdominal Wall/surgery , Abdominal Muscles/surgery , Herniorrhaphy/methods , Treatment Outcome , Aged , Postoperative Complications/etiology , Postoperative Complications/epidemiology , Adult , Abdominal Wound Closure Techniques , Retrospective Studies
14.
Am J Surg ; 232: 68-74, 2024 Jun.
Article En | MEDLINE | ID: mdl-38199871

BACKGROUND: The clinical and financial impact of surgical site infection after ventral hernia repair is significant. Here we investigate the impact of dual antibiotic irrigation on SSI after VHR. METHODS: This was a multicenter, prospective randomized control trial of open retromuscular VHR with mesh. Patients were randomized to gentamicin â€‹+ â€‹clindamycin (G â€‹+ â€‹C) (n â€‹= â€‹125) vs saline (n â€‹= â€‹125) irrigation at time of mesh placement. Primary outcome was 30-day SSI. RESULTS: No significant difference was seen in SSI between control and antibiotic irrigation (9.91 vs 9.09 â€‹%; p â€‹= â€‹0.836). No differences were seen in secondary outcomes: SSO (11.71 vs 13.64 â€‹%; p â€‹= â€‹0.667); 90-day SSO (11.1 vs 13.9 â€‹%; p â€‹= â€‹0.603); 90-day SSI (6.9 vs 3.8 â€‹%; p â€‹= â€‹0.389); SSIPI (7.21 vs 7.27 â€‹%, p â€‹= â€‹0.985); SSOPI (3.6 vs 3.64 â€‹%; p â€‹= â€‹0.990); 30-day readmission (9.91 vs 6.36 â€‹%; p â€‹= â€‹0.335); reoperation (5.41 vs 0.91 â€‹%; p â€‹= â€‹0.056). CONCLUSION: Dual antibiotic irrigation with G â€‹+ â€‹C did not reduce the risk of surgical site infection during open retromuscular ventral hernia repair.


Anti-Bacterial Agents , Gentamicins , Hernia, Ventral , Herniorrhaphy , Surgical Wound Infection , Therapeutic Irrigation , Humans , Hernia, Ventral/surgery , Surgical Wound Infection/prevention & control , Surgical Wound Infection/epidemiology , Male , Female , Middle Aged , Prospective Studies , Herniorrhaphy/adverse effects , Anti-Bacterial Agents/therapeutic use , Anti-Bacterial Agents/administration & dosage , Gentamicins/administration & dosage , Gentamicins/therapeutic use , Incidence , Therapeutic Irrigation/methods , Clindamycin/therapeutic use , Clindamycin/administration & dosage , Aged , Surgical Mesh , Treatment Outcome , Adult
15.
Surgery ; 175(3): 799-805, 2024 Mar.
Article En | MEDLINE | ID: mdl-37716868

BACKGROUND: Mesh has been the acceptable standard for incisional hernia repair regardless of hernia size. It is not clear whether there is a size of incisional hernias in whom repair would be best performed without mesh. This study aims to compare outcomes of mesh versus suture repairs for incisional hernias <2 cm in size. METHODS: Incisional hernia repairs from 2012 to 2021 for hernias ≤2 cm in width were queried from the Abdominal Core Health Quality Collaborative. Those with 1-year follow up were considered. Hernia recurrence was defined using composite hernia recurrence, which combines both clinical and patient reported outcomes. Propensity score matching was performed between mesh and non-mesh using body mass index, smoking, diabetes, and drains as covariates. RESULTS: A total of 352 patients met inclusion criteria. After propensity score matching, there were 132 repairs with mesh and 71 without. There was no difference in recurrence rates at 1 year between mesh and non-mesh repairs (15% vs 24%, P = .12). Mesh was associated with a higher rate of 30-day postoperative complications (11% vs 1%, P = .017). There were no differences in 1-year quality of life scores. CONCLUSION: The repair of incisional hernias ≤2 cm without mesh results in similar recurrence rates, similar quality of life scores, and lower postoperative early complications compared with repairs with mesh. Our findings suggest that there may be select patients with small incisional hernias that could reasonably undergo incisional hernia repair without mesh. Longer-term follow-up is needed to confirm ideal candidates and durability of these repairs.


Hernia, Ventral , Incisional Hernia , Humans , Incisional Hernia/surgery , Incisional Hernia/complications , Surgical Mesh/adverse effects , Propensity Score , Quality of Life , Herniorrhaphy/adverse effects , Herniorrhaphy/methods , Hernia, Ventral/surgery , Hernia, Ventral/etiology , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Postoperative Complications/surgery , Abdominal Core , Sutures/adverse effects , Recurrence
16.
Surgery ; 175(3): 806-812, 2024 Mar.
Article En | MEDLINE | ID: mdl-37741776

BACKGROUND: Morbid obesity, with a body mass index 35 kg/m2, is a commonly used cutoff for denying elective transversus abdominis release. Although obesity is linked to short-term wound morbidity, its effect on long-term outcomes remains unknown, calling into question if a cutoff is justified. We sought to compare 1-year recurrence rates after transversus abdominis release based on body mass index and to evaluate short- and long-term outcomes. METHODS: Patients undergoing open, clean transversus abdominis release from August 2014 to January 2022 at our institution with 1-year follow-up completed were identified. Univariate and multivariable analyses were performed to determine the association of body mass index with 90-day wound events, 1-year hernia recurrence, and hernia-specific quality of life. Covariates included body mass index, diabetes, recurrent hernia, hernia width, fascial closure, surgical site occurrence requiring procedural intervention, previous abdominal wall surgical site infection, inflammatory bowel disease, mesh weight, and mesh-to-hernia size ratio. RESULTS: A total of 1,089 patients were included. Increasing body mass index was associated with surgical site infection (adjusted odds ratio = 1.59; 95% confidence interval, 1.14-1.77; P < .01) and surgical site occurrence (adjusted odds ratio = 1.42; 95% confidence interval, 1.13-1.74; P < .01) but was not associated with surgical site occurrence requiring procedural intervention. Hernia width was associated with surgical site occurrence (adjusted odds ratio = 1.4; 95% confidence interval, 1.08-1.82; P < .01) and surgical site occurrence requiring procedural intervention (adjusted odds ratio = 1.4; 95% confidence interval, 1.08-1.82; P = .01). Hernia recurrence rate at 1 year was lower for the body mass index ≥35 kg/m2 group (7% vs 12%; P = .02). Hernia width (odds ratio = 1.33; 95% confidence interval, 1.02-1.74; P = .04) was associated with recurrence; body mass index was not (P = .11). Both groups experienced significant improvement in hernia-specific quality of life at 1 year. CONCLUSION: Morbid obesity is associated with 90-day wound morbidity; however, short-term complications did not translate to higher reoperation or long-term recurrence rates. The impact of body mass index on hernia recurrence is likely overstated. An arbitrary body mass index cutoff of 35 kg/m2 should not be used to deny symptomatic patients abdominal wall reconstruction.


Abdominal Wall , Hernia, Ventral , Obesity, Morbid , Humans , Abdominal Wall/surgery , Hernia, Ventral/surgery , Hernia, Ventral/etiology , Surgical Wound Infection/etiology , Body Mass Index , Quality of Life , Obesity, Morbid/complications , Obesity, Morbid/surgery , Treatment Outcome , Herniorrhaphy/adverse effects , Surgical Mesh/adverse effects , Recurrence , Retrospective Studies
17.
Am J Surg ; 230: 21-25, 2024 Apr.
Article En | MEDLINE | ID: mdl-37914661

INTRODUCTION: Guidelines recommend MIS repairs for females with inguinal hernias, despite limited evidence. We investigated rates of femoral hernias intraoperatively noted during MIS and Lichtenstein repairs in females. METHODS: ACHQC was queried for adult females undergoing inguinal hernia repair between January 2014-November 2022. Outcomes included identified femoral hernia and size, hernia recurrence, quality of life, and sex-based recurrence. RESULTS: 1357 and 316 females underwent MIS and Lichtenstein inguinal repair respectively. Femoral hernias were identified more frequently in MIS than open repairs (27%vs12%; (p â€‹< â€‹0.001). Most femoral hernias in MIS (61%) and Lichtenstein repairs (62%) were <1.5 â€‹cm(p â€‹< â€‹0.001). Identification rates of femoral hernias >3 â€‹cm were 1% overall(p â€‹= â€‹0.09). Surgeon and patient-reported recurrences were similar between approaches at 1-5-years for females(p â€‹> â€‹0.05 for all) and similar between sexes(p â€‹> â€‹0.05). CONCLUSION: Most incidental femoral hernias are small and both repair approaches demonstrated similar outcomes. The recommendation for MIS inguinal hernia repairs in females is potentially overstated.


Hernia, Femoral , Hernia, Inguinal , Laparoscopy , Adult , Female , Humans , Hernia, Inguinal/diagnosis , Hernia, Inguinal/surgery , Hernia, Femoral/diagnosis , Hernia, Femoral/surgery , Quality of Life , Recurrence , Herniorrhaphy , Surgical Mesh
19.
Am J Surg ; 229: 52-56, 2024 Mar.
Article En | MEDLINE | ID: mdl-37833195

INTRODUCTION: Many studies identify active smoking as a significant risk factor for postoperative wound and mesh complications in patients undergoing abdominal wall reconstruction surgery. However, our group conducted an analysis using data from the ACHQC database, which revealed similar rates of surgical site infection (SSI) and surgical site occurrence requiring procedural intervention (SSOPI) between active smokers and non-smokers As a result, the Cl eveland Clinic Center for Abdominal Core Health instituted a policy change where active smokers were no longer subject to surgical delay. Our study aims to evaluate the impact of active smoking on the outcomes of these patients. METHODS: We identified active smoking patients who had undergone open, elective, clean ventral hernia repair (VHR) with transversus abdominis release (TAR) and permanent synthetic mesh at Cleveland Clinic Foundation. Propensity matching was performed to create a 1:3 ratio of "current-smokers" and "never-smokers" and compared wound complications and all 30-day morbidity between the two groups. RESULTS: 106 current-smokers and 304 never-smokers were matched. Demographics were similar between the two groups after matching, with the exception of chronic obstructive pulmonary disease (COPD) (22.1% vs. 13.4%, p â€‹< â€‹.001) and body mass index (BMI) (31.1 vs. 32.6, p â€‹= â€‹.02). Rates of SSI (12.2% vs. 6.9%, p â€‹= â€‹.13), SSO (21.7% vs. 13.2%, p â€‹= â€‹.052), SSOPI (11.3% vs. 6.3%, p â€‹= â€‹.13), and reoperation (1.9% vs. 3.9%, p â€‹= â€‹.53) were not significantly different between active smokers and never-smokers correspondingly. One case (0.3%) of partial mesh excision was observed in the never-smokers group (p â€‹= â€‹1). The current-smokers group exhibited a significantly higher incidence of pneumonia compared to the never-smokers group (5.7% vs. 0.7%, p â€‹= â€‹.005). CONCLUSION: Our study revealed that operating on active smokers did result in a slight increase in wound morbidity, although it did not reach statistical significance. Additionally, pulmonary complications were higher in the smoking group. Notably, we did not see any mesh infections in the smoking group during early follow up. We believe that this data is important for shared decision making on patients that are actively smoking contemplating elective hernia repair.


Abdominal Wall , Hernia, Ventral , Smoking Cessation , Humans , Abdominal Wall/surgery , Lifting , Surgical Wound Infection/epidemiology , Surgical Wound Infection/prevention & control , Surgical Wound Infection/etiology , Hernia, Ventral/complications , Herniorrhaphy/adverse effects , Surgical Mesh/adverse effects , Retrospective Studies , Treatment Outcome
20.
Inflamm Bowel Dis ; 30(3): 357-369, 2024 Mar 01.
Article En | MEDLINE | ID: mdl-37524088

BACKGROUND: Perianal fistulas and abscesses occur commonly as complications of pediatric Crohn's disease (CD). A validated imaging assessment tool for quantification of perianal disease severity and activity is needed to evaluate treatment response. We aimed to identify magnetic resonance imaging (MRI)-based measures of perianal fistulizing disease activity and study design features appropriate for pediatric patients. METHODS: Seventy-nine statements relevant to MRI-based assessment of pediatric perianal fistulizing CD activity and clinical trial design were generated from literature review and expert opinion. Statement appropriateness was rated by a panel (N = 15) of gastroenterologists, radiologists, and surgeons using modified RAND/University of California Los Angeles appropriateness methodology. RESULTS: The modified Van Assche Index (mVAI) and the Magnetic Resonance Novel Index for Fistula Imaging in CD (MAGNIFI-CD) were considered appropriate instruments for use in pediatric perianal fistulizing disease clinical trials. Although there was concern regarding the use of intravascular contrast material in pediatric patients, its use in clinical trials was considered appropriate. A clinically evident fistula tract and radiologic disease defined as at least 1 fistula or abscess on pelvic MRI were considered appropriate trial inclusion criteria. A coprimary clinical and radiologic end point and inclusion of a patient-reported outcome were also considered appropriate. CONCLUSION: Outcomes of treatment of perianal fistulizing disease in children must include MRI. Existing multi-item measures, specifically the mVAI and MAGNIFI-CD, can be adapted and used for children. Further research to assess the operating properties of the indices when used in a pediatric patient population is ongoing.


Crohn Disease , Fistula , Child , Humans , Abscess , Crohn Disease/complications , Crohn Disease/diagnostic imaging , Magnetic Resonance Imaging , Clinical Trials as Topic
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