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

NCT ID: NCT01719718

Last Updated: 2024-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ventral Hernia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Closure

Group Type ACTIVE_COMPARATOR

Closure of hernia defect.

Intervention Type PROCEDURE

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

Non-Closure

Group Type SHAM_COMPARATOR

No closure of the hernia defect.

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Closure of hernia defect.

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

Intervention Type PROCEDURE

No closure of the hernia defect.

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Frederik Berrevoet, MD, PhD, FACS

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Algemeen Stedelijk Ziekenhuis

Aalst, , Belgium

Site Status

Imelda Hospital

Bonheiden, , Belgium

Site Status

St Vincentius Hospital

Deinze, , Belgium

Site Status

Ghent University Hospital

Ghent, , Belgium

Site Status

Maria Middelares

Ghent, , Belgium

Site Status

Hôpital Mont Godinne

Namur, , Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2012/075

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.