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 May

REPOSITORIES: biostudies-literature

ACCESS DATA

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

Similar Datasets

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.

Publications

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

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets