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Prospective cohort study on mesh shrinkage measured with MRI after laparoscopic ventral hernia repair with an intraperitoneal iron oxide-loaded PVDF mesh.

ABSTRACT: BACKGROUND:Current data on shrinkage of intraperitoneal meshes come mainly from animal studies. High-quality human data in prospective studies are scarce. METHODS:We used the ability to visualize intraperitoneal PVDF meshes enhanced with iron particles (DynaMesh IPOM visible) with magnetic resonance imaging (MRI) to determine the amount of shrinkage between 1 and 13 months postoperatively. All measurements of the width, length, and surface area of the mesh were performed with a standardized methodology independently by four radiologists blinded for the timing of the MRI. RESULTS:Of the 15 patients undergoing laparoscopic ventral hernia repair, 13 patients received an MRI both at 1 and at 13 months. Evaluation of inter-rater reliability between the radiologists showed intra-class correlations of 0.95 (95% CI 0.92-0.98) for the width, 0.96 (95% CI 0.93-0.98) for the length, and 0.99 (90% CI 0.99-1.00) for the surface area of the mesh. The change between measurement at implantation and 1-month MRI was -?0.7 cm (P?=?0.023; -?3.6%) for the width and -?1.9 cm (P?=?0.001; -?7.2%) for the length. The change between 1 and 13 months was -?0.06 cm (P?=?0.74; shrinkage?=?0.3%) for the width, -?0.12 cm (P?=?0.56; shrinkage?=?0.5%) for the length, and -?4.0 cm2 (P?=?0.20; shrinkage?=?1.0%) for the surface area of the mesh. CONCLUSION:There is excellent inter-rater reliability between radiologists when measuring width, length, and surface area of visible intraperitoneal PVDF mesh with MRI. There is no significant shrinkage between 1 and 13 months of intraperitoneal PVDF mesh after laparoscopic ventral hernia repair.

SUBMITTER: Muysoms F

PROVIDER: S-EPMC5956096 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

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Prospective cohort study on mesh shrinkage measured with MRI after laparoscopic ventral hernia repair with an intraperitoneal iron oxide-loaded PVDF mesh.

Muysoms Filip F Beckers Roel R Kyle-Leinhase Iris I

Surgical endoscopy 20171221 6

<h4>Background</h4>Current data on shrinkage of intraperitoneal meshes come mainly from animal studies. High-quality human data in prospective studies are scarce.<h4>Methods</h4>We used the ability to visualize intraperitoneal PVDF meshes enhanced with iron particles (DynaMesh IPOM visible) with magnetic resonance imaging (MRI) to determine the amount of shrinkage between 1 and 13 months postoperatively. All measurements of the width, length, and surface area of the mesh were performed with a st ...[more]

PMID: 29270800

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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

Prospective cohort study on mesh shrinkage measured with MRI after laparoscopic ventral hernia repair with an intraperitoneal iron oxide-loaded PVDF mesh.

Publications

Prospective cohort study on mesh shrinkage measured with MRI after laparoscopic ventral hernia repair with an intraperitoneal iron oxide-loaded PVDF mesh.

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