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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01719718

Acronym

CLOSURE

Enrollment

Registered

2012-11-01

Start date

2012-10-31

Completion date

2023-12-31

Last updated

2024-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventral Hernia

Keywords

ventral hernia

Brief summary

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.

Interventions

PROCEDUREClosure of hernia defect.

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

PROCEDURENo closure of the hernia defect.

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Seroma formation after 4 weeks.	4 weeks after surgery.	The seroma formation is checked by clinical evaluation.

Secondary

Measure	Time frame	Description
Pain, discomfort and esthetic evaluation after 4 weeks.	4 weeks after surgery.	Pain, discomfort and esthetic evaluation is performed after 4 weeks by clinical evaluation and the Visual Analogue Scale.
Pain, discomfort and esthetic evaluation after 1 year.	1 year after surgery.	Pain, discomfort and esthetic evaluation is performed after 1 year by clinical evaluation and the Visual Analogue Scale.
Pain, discomfort and esthetic evaluation after 2 years.	2 years after surgery.	Pain, discomfort and esthetic evaluation is performed after 2 years by clinical evaluation and the Visual Analogue Scale.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026