The Influence of Closing the Gap on Postoperative Seroma and Recurrences in Laparoscopic Ventral Hernia Repair

N/ACompletedNCT01719718

University Hospital, Ghent93 enrolled

Overview

A multicenter prospective randomized controlled trial comparing closure versus non-closure of the hernia defect between 2 and 5 cm in width using a tissue separating mesh (Physiomesh™) in laparoscopic ventral hernia repair.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ventral Hernia

Interventions

Closure of hernia defect.PROCEDURE

Laparoscopic ventral hernia repair with closure of the hernia defect (mesh augmentation technique).

No closure of the hernia defect.PROCEDURE

Conventional laparoscopic ventral hernia repair without closure of the hernia defect (defect bridging technique).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Written informed consent from the patient or his/her legal representative * Ventral or incisional hernia requiring elective surgical repair * Diameter between 2 and 5cm in width * Midline and flank hernias are eligible Exclusion Criteria: * No written informed consent * 'Hostile' abdomen, open abdomen treatment * Contraindication to pneumoperitoneum * Emergency surgery (incarcerated hernia) * Parastomal hernia * Subxiphoidal hernia * Subcostal hernia * Suprapubic hernia * Clean-contaminated or contaminated field * Hernia diameter \>5cm in width * Pregnancy * Non-compliance

Locations (6)

Algemeen Stedelijk Ziekenhuis

Aalst, Belgium

Imelda Hospital

Bonheiden, Belgium

St Vincentius Hospital

Deinze, Belgium

Ghent University Hospital

Ghent, Belgium

Maria Middelares

Outcomes

Primary Outcomes

Seroma formation after 4 weeks.

The seroma formation is checked by clinical evaluation.

Time frame: 4 weeks after surgery.

Secondary Outcomes

Pain, discomfort and esthetic evaluation after 4 weeks.

Pain, discomfort and esthetic evaluation is performed after 4 weeks by clinical evaluation and the Visual Analogue Scale.

Time frame: 4 weeks after surgery.

Pain, discomfort and esthetic evaluation after 1 year.

Pain, discomfort and esthetic evaluation is performed after 1 year by clinical evaluation and the Visual Analogue Scale.

Time frame: 1 year after surgery.

Pain, discomfort and esthetic evaluation after 2 years.

Pain, discomfort and esthetic evaluation is performed after 2 years by clinical evaluation and the Visual Analogue Scale.

Time frame: 2 years after surgery.

Data from ClinicalTrials.gov

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