Dataset Information

Peritoneal bridging versus fascial closure in laparoscopic intraperitoneal onlay ventral hernia mesh repair: a randomized clinical trial.

ABSTRACT:

Background

Many patients develop seroma after laparoscopic ventral hernia repair. It was hypothesized that leaving the hernial sac in situ may cause this complication.

Methods

In this patient- and outcome assessor-blinded, parallel-design single-centre trial, patients undergoing laparoscopic intraperitoneal onlay mesh ventral hernia repair were randomized (1 : 1) to either conventional fascial closure or peritoneal bridging. The primary endpoint was the incidence of seroma 12 months after index surgery detected by CT, evaluated in an intention-to-treat analysis.

Results

Between September 2017 and May 2018, 62 patients were assessed for eligibility, of whom 25 were randomized to conventional closure and 25 to peritoneal bridging. At 3 months, one patient was lost to follow-up in the conventional and peritoneal bridging groups respectively. No seroma was detected at 6 or 12 months in either group. The prevalence of clinical seroma was four of 25 (16 (95 per cent c.i. 2 to 30) per cent) versus none of 25 patients in the conventional fascial closure and peritoneal bridging groups respectively at 1 month after surgery (P = 0·110), and two of 24 (8 (0 to 19) per cent) versus none of 25 at 3 months (P = 0·235). There were no significant differences between the groups in other postoperative complications (one of 25 versus 0 of 25), rate of recurrent hernia within 1 year (none in either group) or postoperative pain.

Conclusion

Conventional fascial closure and peritoneal bridging did not differ with regard to seroma formation after laparoscopic ventral hernia repair.

Trial registration

ClinicalTrials.gov (NCT03344575).

SUBMITTER: Ali F

PROVIDER: S-EPMC7397363 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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Publications

Peritoneal bridging versus fascial closure in laparoscopic intraperitoneal onlay ventral hernia mesh repair: a randomized clinical trial.

Ali F F Wallin G G Fathalla B B Sandblom G G

BJS open 20200528 4

<h4>Background</h4>Many patients develop seroma after laparoscopic ventral hernia repair. It was hypothesized that leaving the hernial sac in situ may cause this complication.<h4>Methods</h4>In this patient- and outcome assessor-blinded, parallel-design single-centre trial, patients undergoing laparoscopic intraperitoneal onlay mesh ventral hernia repair were randomized (1 : 1) to either conventional fascial closure or peritoneal bridging. The primary endpoint was the incidence of seroma 12 mont ...[more]

PMID: 32463163

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Project description:Ventral hernias pose a prevalent challenge in abdominal wall surgery, with ongoing advancements in repair techniques designed to enhance patient outcomes. This study evaluates the efficacy, safety, and socio-economic impact of Totally Extraperitoneal Sublay Repair (TES) versus Laparoscopic Intraperitoneal Onlay Mesh Repair (IPOM) for small to medium-sized ventral hernias, with a particular focus on postoperative quality of life and patient satisfaction. A retrospective cohort study was conducted, encompassing 125 patients who underwent ventral hernia repair between May 2018 and November 2023. The cohort included 55 patients treated with TES and 70 with Laparoscopic IPOM. Baseline characteristics, including age, gender, BMI, operative time, postoperative pain, hospitalization costs, and patient satisfaction score, were compared. Postoperative quality of life was evaluated through outpatient visits or telephone follow-ups. The propensity score matching (PSM) technique was applied in a 1:1 ratio to balance the significant differences in general characteristics between the two groups. Out of 125 patients, 70 cases were successfully matched using the PSM method, resulting in 35 cases in each group. The baseline characteristics of patients in groups were well-matched (P > 0.05). The TES group exhibited a significantly longer operative duration (P < 0.001); however, this group also experienced markedly reduced postoperative pain, decreased hospitalization costs, and diminished postoperative drainage (all P < 0.001). The length of hospital stay and the incidence of long-term complications were similar between the two groups. Follow-up evaluations at 3 and 6 months showed a significantly improved quality of life and higher patient satisfaction in the TES group. Both TES and IPOM demonstrate comparable safety and efficacy in the repair of ventral hernias. Although TES is associated with a longer operative duration, it provides significant advantages in postoperative quality of life, patient satisfaction, and cost-effectiveness, thereby supporting its broader clinical adoption.

Project description:ImportanceDespite rapid adoption of the robotic platform for ventral hernia repair with intraperitoneal mesh in the United States, there is no level I evidence comparing it with the traditional laparoscopic approach. This randomized clinical trial sought to demonstrate a clinical benefit to the robotic approach.ObjectiveTo determine whether robotic approach to ventral hernia repair with intraperitoneal mesh would result in less postoperative pain.Design, setting, and participantsA registry-based, single-blinded, prospective randomized clinical trial at the Cleveland Clinic Center for Abdominal Core Health, Cleveland, Ohio, completed between September 2017 and January 2020, with a minimum follow-up duration of 30 days. Two surgeons at 1 academic tertiary care hospital. Patients with primary or incisional midline ventral hernias of an anticipated width of 7 cm or less presenting in the elective setting and able to tolerate a minimally invasive repair.InterventionsPatients were randomized to a standardized laparoscopic or robotic ventral hernia repair with fascial closure and intraperitoneal mesh.Main outcomes and measuresThe trial was powered to detect a 30% difference in the Numerical Rating Scale (NRS-11) on the first postoperative day. Secondary end points included the Patient-Reported Outcomes Measurement Information System Pain Intensity short form (3a), hernia-specific quality of life, operative time, wound morbidity, recurrence, length of stay, and cost.ResultsSeventy-five patients completed their minimally invasive hernia repair: 36 laparoscopic and 39 robotic. Baseline demographics and hernia characteristics were comparable. Robotic operations had a longer median operative time (146 vs 94 minutes; P < .001). There were 2 visceral injuries in each cohort but no full-thickness enterotomies or unplanned reoperations. There were no significant differences in NRS-11 scores preoperatively or on postoperative days 0, 1, 7, or 30. Specifically, median NRS-11 scores on the first postoperative day were the same (5 vs 5; P = .61). Likewise, postoperative Patient-Reported Outcomes Measurement Information System 3a and hernia-specific quality-of-life scores, as well as length of stay and complication rates, were similar. The robotic platform adds cost (total cost ratio, 1.13 vs 0.97; P = .03), driven by the cost of additional operating room time (1.25 vs 0.85; P < .001).Conclusions and relevanceLaparoscopic and robotic ventral hernia repair with intraperitoneal mesh have comparable outcomes. The increased operative time and proportional cost of the robotic approach are not offset by a measurable clinical benefit.Trial registrationClinicalTrials.gov Identifier: NCT03283982.

Dataset Information

Peritoneal bridging versus fascial closure in laparoscopic intraperitoneal onlay ventral hernia mesh repair: a randomized clinical trial.

Background

Methods

Results

Conclusion

Trial registration

Publications

Peritoneal bridging versus fascial closure in laparoscopic intraperitoneal onlay ventral hernia mesh repair: a randomized clinical trial.

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