Ventral Mesh Hernioplasty : Laparoscopic Versus Open Sublay

November 26, 2023 updated by: ahmed hussein abozeid ahmed, Assiut University
To compare between laparoscopic ventral hernia repair and open sublay technique (recurrence ,operative time ,bleeding ,rate of complication and injury , seroma, post operative pain)

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

A hernia usually happens in abdomen or groin, when one of your organs pushes through the muscle or tissue that contains it. Most hernias eventually will need surgical repair.

sublay mesh repair has the lowest recurrence and surgical site infection in open anterior abdominal hernia repair it is a perfect choice for the repair of ventral abdominal hernia the principles included two main steps: (1) mesh placement deep into the recti muscles and (2) mesh extension beyond the hernia defect.

Laparoscopic ventral hernia repair (LVHR) has established itself as a well-accepted option in the treatment of hernias. Clear benefits have been established regarding the superiority of LVHR in terms of fewer wound infections compared with open repairs. Meticulous technique and appropriate patient selection are critical to obtain the reported results.

• In the laparoscopic technique, a prosthetic mesh is inserted through a trocar into the abdominal cavity and fixed against the abdominal wall. After reducing the hernia contents, the hernia sac is left unresected, and most surgeons do not place additional sutures for closing the hernia orifice. A specific risk of laparoscopic hernia repair lies in freeing adhesions between intestine and abdominal wall, which may result in (sometimes unrecognised) bowel perforation . The mesh should overlap the hernia orifice by at least 5 cm and is anchored to the abdominal wall with tacks, transfascial sutures, or a combination of the two methods. In laparoscopic abdominal hernia repair, mesh placement methods are generally classified into intraperitoneal onlay mesh (IPOM), transabdominal abdominal preperitoneal (TAPP)

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • All cases of midline ventral hernia fit for surgery

Exclusion Criteria:

  1. Surgically unfit cases
  2. Complicated hernia (obstructed ,irreducible, strangulated)
  3. incisional ,massive ,recurrent hernias

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: sublay
patients with ventral hernia operated as sublay mesh repair positioning of mesh under sheath
Procedure: hernioplasty
ventral hernia repair with mesh
Experimental: laparoscopic
patients with ventral hernia operated as laparoscopic repair positioning TAPP mesh
Procedure: hernioplasty
ventral hernia repair with mesh

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recurrence rate
Time Frame: baseline
compare between laparoscopic ventral hernia repair and open sublay technique in how long the hernia take to occur again
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: hisham ryad

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

November 10, 2023

First Submitted That Met QC Criteria

November 26, 2023

First Posted (Actual)

November 29, 2023

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 26, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ventral hernia repair

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ventral Hernia

Clinical Trials on hernioplasty

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo, DR of

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe