Ventral Mesh Hernioplasty : Laparoscopic Versus Open Sublay

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06149858
Collaborator
(none)
30
2
27

Study Details

Study Description

Brief Summary

To compare between laparoscopic ventral hernia repair and open sublay technique (recurrence ,operative time ,bleeding ,rate of complication and injury , seroma, post operative pain)

Condition or Disease Intervention/Treatment Phase
  • Procedure: hernioplasty
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Ventral Mesh Hernioplasty : Laparoscopic Versus Open Sublay
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Dec 30, 2025
Anticipated Study Completion Date :
Mar 1, 2026

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. recurrence rate [baseline]

    compare between laparoscopic ventral hernia repair and open sublay technique in how long the hernia take to occur again

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

  • Study Director: hisham ryad,

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
ahmed hussein abozeid ahmed, resident doctor, Assiut University
ClinicalTrials.gov Identifier:
NCT06149858
Other Study ID Numbers:
  • ventral hernia repair
First Posted:
Nov 29, 2023
Last Update Posted:
Nov 29, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 29, 2023