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1.
Surg Endosc ; 38(6): 3433-3440, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38710888

ABSTRACT

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.


Subject(s)
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
2.
Surgery ; 176(1): 148-153, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38641542

ABSTRACT

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.


Subject(s)
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
4.
J Am Coll Surg ; 238(6): 1115-1120, 2024 Jun 01.
Article in English | MEDLINE | ID: mdl-38372372

ABSTRACT

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.


Subject(s)
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
5.
Am J Surg ; 232: 68-74, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38199871

ABSTRACT

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.


Subject(s)
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
6.
Surgery ; 175(3): 799-805, 2024 Mar.
Article in English | MEDLINE | ID: mdl-37716868

ABSTRACT

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.


Subject(s)
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
7.
Surgery ; 175(3): 806-812, 2024 Mar.
Article in English | MEDLINE | ID: mdl-37741776

ABSTRACT

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.


Subject(s)
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
8.
Am J Surg ; 229: 52-56, 2024 Mar.
Article in English | MEDLINE | ID: mdl-37833195

ABSTRACT

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.


Subject(s)
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
9.
Surgery ; 175(3): 813-821, 2024 Mar.
Article in English | MEDLINE | ID: mdl-37770344

ABSTRACT

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.


Subject(s)
Hernia, Ventral , Incisional Hernia , Laparoscopy , Surgical Stomas , Adult , Humans , Herniorrhaphy/adverse effects , Surgical Mesh/adverse effects , Incisional Hernia/surgery , Incisional Hernia/complications , Surgical Stomas/adverse effects , Colostomy/adverse effects , Hernia, Ventral/etiology , Hernia, Ventral/surgery , Laparoscopy/adverse effects
10.
JAMA Surg ; 158(12): 1321-1326, 2023 Dec 01.
Article in English | MEDLINE | ID: mdl-37792324

ABSTRACT

Importance: Posterior components separation (PCS) is a commonly used myofascial release technique in ventral hernia repairs. The contribution of each release with anterior and posterior fascial advancement has not yet been characterized in patients with ventral hernias. Objective: To quantitatively assess the changes in tension on the anterior and posterior fascial elements of the abdominal wall during PCS to inform surgeons regarding the technical contribution of each step with those changes, which may help to guide intraoperative decision-making. Design, Setting, and Participants: This case series enrolled patients from December 2, 2021, to August 2, 2022, and was conducted at the Cleveland Clinic Center for Abdominal Core Health. The participants included adult patients with European Hernia Society classification M1 to M5 ventral hernias undergoing abdominal wall reconstruction with PCS. Intervention: A proprietary, sterilizable tensiometer measured the force needed to bring the fascial edge of the abdominal wall to the midline after each step of a PCS (retrorectus dissection, division of the posterior lamella of the internal oblique aponeurosis, and transversus abdominis muscle release [TAR]). Main Outcome: The primary study outcome was the percentage change in tension on the anterior and posterior fascia associated with each step of PCS with TAR. Results: The study included 100 patients (median [IQR] age, 60 [54-68] years; 52 [52%] male). The median (IQR) hernia width was 13.0 (10.0-15.2) cm. After complete PCS, the mean (SD) percentage changes in tension on the anterior and posterior fascia were -53.27% (0.53%) and -98.47% (0.08%), respectively. Of the total change in anterior fascial tension, retrorectus dissection was associated with a mean (SD) percentage change of -82.56% (0.68%), incision of the posterior lamella of the internal oblique with a change of -17.67% (0.41%), and TAR with no change. Of the total change in posterior fascial tension, retrorectus dissection was associated with a mean (SD) percentage change of -3.04% (2.42%), incision of the posterior lamella of the internal oblique with a change of -58.78% (0.39%), and TAR with a change of -38.17% (0.39%). Conclusions and Relevance: In this case series, retrorectus dissection but not TAR was associated with reduced tension on the anterior fascia, suggesting that it should be performed if anterior fascial advancement is needed. Dividing the posterior lamella of the internal oblique aponeurosis and TAR was associated with reduced tension on the posterior fascia, suggesting that it should be performed for posterior fascial advancement.


Subject(s)
Abdominal Wall , Abdominoplasty , Hernia, Ventral , Surgical Wound , Adult , Humans , Male , Middle Aged , Female , Abdominal Wall/surgery , Abdominal Muscles/surgery , Hernia, Ventral/surgery , Fascia , Herniorrhaphy/methods , Surgical Mesh
11.
Surg Clin North Am ; 103(5): 889-900, 2023 Oct.
Article in English | MEDLINE | ID: mdl-37709394

ABSTRACT

Chronic postoperative inguinal pain, CPIP, afflicts 10% to 15% of the nearly 700,000 Americans who have inguinal hernia surgery every year. CPIP is challenging to manage because it poses many diagnostic dilemmas that can be overcome with a thorough history, examination, differential diagnosis, and imaging. The initial treatment of CPIP should explore all nonsurgical therapies including medications, physical therapy, interventional pain management and cognitive therapy. When nonoperative methods fail, surgical interventions including neurectomy and hernia mesh removal have proven to be beneficial for patients with CPIP.


Subject(s)
Hernia, Inguinal , Humans , Diagnosis, Differential , Hernia, Inguinal/diagnosis , Hernia, Inguinal/surgery , Inositol Phosphates , Pain
12.
Surg Clin North Am ; 103(5): xv-xvi, 2023 10.
Article in English | MEDLINE | ID: mdl-37709403
13.
JAMA Surg ; 158(8): 789-795, 2023 08 01.
Article in English | MEDLINE | ID: mdl-37342018

ABSTRACT

Importance: Transfascial (TF) mesh fixation in open retromuscular ventral hernia repair (RVHR) has been advocated to reduce hernia recurrence. However, TF sutures may cause increased pain, and, to date, the purported advantages have never been objectively measured. Objective: To determine whether abandonment of TF mesh fixation would result in a noninferior hernia recurrence rate at 1 year compared with TF mesh fixation in open RVHR. Design, Setting, and Participants: In this prospective, registry-based, double-blinded, noninferiority, parallel-group, randomized clinical trial, a total of 325 patients with a ventral hernia defect width of 20 cm or less with fascial closure were enrolled at a single center from November 29, 2019, to September 24, 2021. Follow-up was completed December 18, 2022. Interventions: Eligible patients were randomized to mesh fixation with percutaneous TF sutures or no mesh fixation with sham incisions. Main Outcome and Measures: The primary outcome was to determine whether no TF suture fixation was noninferior to TF suture fixation for open RVHR with regard to recurrence at 1 year. A 10% noninferior margin was set. The secondary outcomes were postoperative pain and quality of life. Results: A total of 325 adults (185 women [56.9%]; median age, 59 [IQR, 50-67] years) with similar baseline characteristics were randomized; 269 patients (82.8%) were followed up at 1 year. Median hernia width was similar in the TF fixation and no fixation groups (15.0 [IQR, 12.0-17.0] cm for both). Hernia recurrence rates at 1 year were similar between the groups (TF fixation, 12 of 162 [7.4%]; no fixation, 15 of 163 [9.2%]; P = .70). Recurrence-adjusted risk difference was found to be -0.02 (95% CI, -0.07 to 0.04). There were no differences in immediate postoperative pain or quality of life. Conclusions and Relevance: The absence of TF suture fixation was noninferior to TF suture fixation for open RVHR with synthetic mesh. Transfascial fixation for open RVRH can be safely abandoned in this population. Trial Registration: ClinicalTrials.gov Identifier: NCT03938688.


Subject(s)
Hernia, Ventral , Quality of Life , Adult , Humans , Female , Middle Aged , Prospective Studies , Surgical Mesh/adverse effects , Hernia, Ventral/surgery , Pain, Postoperative/etiology , Herniorrhaphy/adverse effects
14.
J Am Coll Surg ; 237(3): 525-532, 2023 09 01.
Article in English | MEDLINE | ID: mdl-37171090

ABSTRACT

BACKGROUND: Patient-reported outcomes in clinical research allow for a more comprehensive and meaningful assessment of interventions but are subjective and difficult to interpret. European Registry for Abdominal Wall Hernias-Quality of Life (EuraHS-QoL) is a tool designed to assess perioperative quality of life for patients undergoing inguinal hernia repair, one of the most performed operations worldwide. Defining the minimum clinically important difference (MCID) for EuraHS-QoL tool can help standardize its interpretation for research purposes and facilitate improved shared decision making in clinical settings. STUDY DESIGN: A combination of 3 approaches for estimating MCIDs was used in this study. First, 2 distribution-based approaches were used that based estimates on statistical parameters of the data. The SEM provided a minimum value for the MCID, and one-half of the SD provided a point estimate of the MCID. Second, anchor-based approaches integrated patient perceptions of their overall well-being before and after surgery to provide benchmarks for the MCID. Last, iterative surveys of expert hernia surgeons were used to yield the final MCIDs for each domain and the composite EuraHS-QoL score. RESULTS: The overall range of EuraHS-QoL is 0 to 90, with subdomain ranges of 0 to 30 for the pain domain, 0 to 40 for the restriction of activities domain, and 0 to 20 for the cosmesis domain, with higher scores representing worse outcomes. The overall MCID for EuraHS-QoL is 10. Domain-specific MCIDs are 3 for the pain domain, 5 for the restriction of activities domain, and 2 for the cosmesis domain. CONCLUSIONS: In this study, we define overall and domain-specific MCIDs for the EuraHS-QoL instrument using statistical methods, patient-based methods, and clinical expertise, providing estimates that are both statistically and clinically significant.


Subject(s)
Hernia, Inguinal , Humans , Hernia, Inguinal/surgery , Quality of Life , Patient Reported Outcome Measures , Surveys and Questionnaires , Pain
15.
Ann Surg ; 277(4): e900-e906, 2023 04 01.
Article in English | MEDLINE | ID: mdl-35793810

ABSTRACT

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.


Subject(s)
Abdominal Wall , Hernia, Ventral , Humans , Middle Aged , Hernia, Ventral/surgery , Retrospective Studies , Surgical Mesh , Quality of Life , Treatment Outcome , Herniorrhaphy/methods , Abdominal Muscles/surgery , Patient Reported Outcome Measures , Pain , Recurrence , Abdominal Wall/surgery
16.
Surg Endosc ; 37(1): 723-728, 2023 01.
Article in English | MEDLINE | ID: mdl-35578051

ABSTRACT

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.


Subject(s)
Hernia, Inguinal , Laparoscopy , Neuralgia , Robotic Surgical Procedures , Humans , Hernia, Inguinal/surgery , Quality of Life , Herniorrhaphy , Neuralgia/surgery , Surgical Mesh
17.
Surg Endosc ; 37(3): 2143-2153, 2023 03.
Article in English | MEDLINE | ID: mdl-36323978

ABSTRACT

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.


Subject(s)
Hernia, Ventral , Incisional Hernia , Laparoscopy , Robotic Surgical Procedures , Humans , Robotic Surgical Procedures/methods , Quality of Life , Analgesics, Opioid , Surgical Mesh , Herniorrhaphy/methods , Hernia, Ventral/surgery , Pain, Postoperative/etiology , Pain, Postoperative/prevention & control , Pain, Postoperative/surgery , Laparoscopy/methods , Incisional Hernia/surgery
18.
J Am Coll Surg ; 236(1): 220-234, 2023 01 01.
Article in English | MEDLINE | ID: mdl-36106747

ABSTRACT

BACKGROUND: Lateral abdominal wall hernias are relatively rare and present unique challenges to repair. Our group has developed an algorithm for repair based on several anatomic characteristics identified on preoperative imaging. Herein, we report our algorithm and outcomes of a large series of open retromuscular lateral abdominal wall hernia repairs. STUDY DESIGN: Open retromuscular lateral abdominal wall hernia repairs performed at our institution from August 2014 through April 2021 were identified in the Abdominal Core Health Quality Collaborative. Hernia characteristics, etiology, operative techniques, postoperative outcomes, and long-term patient-reported outcomes were extracted from the Abdominal Core Health Quality Collaborative database, chart review, and telephone follow-up. RESULTS: Of 464 patients who underwent hernia repair, 121 with isolated lateral abdominal wall hernias (L1-4) and mean follow-up of 34 ± 24 months had a clinical recurrence rate of 0.9% (n = 1) and bulge rate of 37% (n = 42). The median Hernia-Related Quality of Life Survey and PROMIS pain intensity scores improved 37 and 9 points, respectively. Another 343 patients with lateral (L1-4) and midline (M1-5) abdominal wall hernias and mean follow-up of 29 ± 21 months had a clinical recurrence rate of 6% (n = 20) and bulge rate of 35% (n = 117). The median Hernia-Related Quality of Life Survey and PROMIS pain intensity scores improved by 43 and 16 points, respectively. CONCLUSION: We present an algorithm for open retromuscular lateral abdominal wall hernia repair with relatively low anatomic recurrence rates and substantial improvement in patient-reported quality of life and pain. Notably, postoperative bulging is commonly reported by patients, likely due to underlying denervation injuries from the original incision.


Subject(s)
Abdominal Wall , Hernia, Ventral , Incisional Hernia , Humans , Herniorrhaphy/methods , Quality of Life , Surgical Mesh , Hernia, Ventral/surgery , Abdominal Wall/surgery , Recurrence , Incisional Hernia/surgery
19.
J Am Coll Surg ; 234(6): 1160-1165, 2022 06 01.
Article in English | MEDLINE | ID: mdl-35703814

ABSTRACT

BACKGROUND: Laparoscopic and robotic ventral hernia repair with intraperitoneal mesh have been demonstrated previously to have comparable 30-day outcomes in the PROVE-IT randomized clinical trial. Here we report our 1-year follow-up of enrolled patients to examine exploratory outcomes. STUDY DESIGN: All patients enrolled in a previously published, registry-based, randomized trial investigating laparoscopic vs robotic ventral hernia repair with intraperitoneal mesh were reviewed. Several exploratory secondary outcomes were assessed: pain intensity (Patient-Reported Outcomes Measurement Information System [PROMIS 3a]), hernia-specific quality of life (Hernia-Specific Quality of Life Survey [HerQLes]), composite hernia recurrence, and reoperations. RESULTS: A total of 95% (71 of 75) follow-up was achieved: 33 laparoscopic repairs and 38 robotic repairs. Median follow-up time was 12 months [interquartile range 10 to 12 months]. Following regression analysis adjusting for baseline scores, there was no difference in postoperative pain intensity at 1 year (p = 0.94). However, HerQLes scores increased by 12.0 more points following robotic repairs compared to laparoscopic counterparts (95% CI 1.3 to 22.7, p = 0.03). Composite hernia recurrence was 6% (2 of 33) for the laparoscopic cohort and 24% (9 of 38) for the robotic group (p = 0.04). There was no difference in rates of reoperation (p = 0.61). CONCLUSIONS: Our exploratory analyses have identified potential differences in quality of life and recurrence, favoring the robotic and laparoscopic approaches, respectively. These findings warrant further study with larger patient cohorts to verify their potential significance.


Subject(s)
Hernia, Ventral , Laparoscopy , Robotic Surgical Procedures , Hernia, Ventral/etiology , Hernia, Ventral/surgery , Herniorrhaphy/adverse effects , Humans , Laparoscopy/adverse effects , Quality of Life , Recurrence , Surgical Mesh
20.
JAMA Surg ; 157(8): 667-674, 2022 08 01.
Article in English | MEDLINE | ID: mdl-35704302

ABSTRACT

Importance: Urinary catheters are commonly placed during laparoscopic inguinal hernia repair as a presumed protection against postoperative urinary retention (PUR), one of the most common complications following this operation. Data from randomized clinical trials evaluating the effect of catheters on PUR are lacking. Objective: To investigate the effect of intraoperative catheters on PUR after laparoscopic inguinal hernia repair. Design, Setting, and Participants: This 2-arm registry-based single-blinded randomized clinical trial was conducted at 6 academic and community hospitals in the US from March 2019 to March 2021 with a 30-day follow-up period following surgery. All patients who presented with inguinal hernias were assessed for eligibility, 534 in total. Inclusion criteria were adult patients undergoing laparoscopic, elective, unilateral, or bilateral inguinal hernia repair. Exclusion criteria were inability to tolerate general anesthesia and failure to understand and sign the written consent form. A total of 43 patients were excluded prior to intervention. Interventions: Patients in the treatment arm had placement of a urinary catheter after induction of general anesthesia and removal at the end of procedure. Those in the control arm had no urinary catheter placement. Main Outcomes and Measures: PUR rate. Results: Of the 491 patients enrolled, 241 were randomized to catheter placement, and 250 were randomized to no catheter placement. The median (IQR) age was 61 (51-68) years, and 465 participants (94.7%) were male. Overall, 44 patients (9.1%) developed PUR. There was no difference in the rate of PUR between the catheter and no-catheter groups (23 patients [9.6%] vs 21 patients [8.5%], respectively; P = .79). There were no intraoperative bladder injuries. In the catheter group, there was 1 incident of postoperative urethral trauma in a patient who presented to the emergency department with PUR leading to a suprapubic catheter placement. Conclusions and Relevance: Intraoperative urinary catheters did not reduce the risk of PUR after laparoscopic inguinal hernia repair. While their use did not appear to be associated with a high rate of iatrogenic complications, there may be a low rate of catastrophic complications. In patients who voided urine preoperatively, catheter placement did not appear to confer any advantage and thus their use may be reconsidered. Trial Registration: ClinicalTrials.gov Identifier: NCT03835351.


Subject(s)
Hernia, Inguinal , Laparoscopy , Urinary Retention , Adult , Aged , Female , Hernia, Inguinal/complications , Hernia, Inguinal/surgery , Herniorrhaphy/methods , Humans , Laparoscopy/adverse effects , Laparoscopy/methods , Male , Middle Aged , Postoperative Complications/etiology , Postoperative Complications/prevention & control , Postoperative Complications/surgery , Urinary Retention/etiology , Urinary Retention/prevention & control , Urinary Retention/surgery
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