Onlay Versus Sublay Mesh in Incisional Hernia

December 26, 2023 updated by: Mark Awny Albeir Saad, Assiut University

Onlay Versus Sublay Hernioplasty in Management of Incisional Hernia

Onlay versus Sublay Mesh hernioplasty in management of incisional Hernia Comparative prospective study (Short term outcomes)

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Comparison between Short term outcomes (advantages and disadvantages) of sublay and onlay techniques in management of incisional hernia regarding :

  • Short term complications (superficial skin infection, seroma formation , recurrence and chronic abdominal discomfort.)
  • operative time , hospital stay , difficulty of technique.

Study Type

Observational

Enrollment (Estimated)

40

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

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

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Any patient presenting with incisional hernia for elective hernioplasty that is Surgically Fit and match inclusion critiria

Description

Inclusion Criteria:

  • Surgically Fit patients
  • Patients presented with incisional Hernias
  • Age between 18 to 60 years
  • Cicatrized incisional hernia involving both muscle cutting and muscle splitting incisions

Exclusion Criteria:

  • Surgically unfit patients
  • Irreducible, obstructed, strangulated hernias
  • Other Ventral hernias that not related to surgical incision.
  • Huge hernias with wide abdominal wall defect and retracted abdominal wall muscles.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Sublay hernioplasty in incisional hernia
Group that will undergo Sublay hernioplasty in management of incisional hernia
Procedure: Hernioplasty
Surgical hernioplasty
Onlay Hernioplasty in incisional hernia
Group that will undergo Onlay hernioplasty in management of incisional hernia
Procedure: Hernioplasty
Surgical hernioplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short term complications
Time Frame: 1 month
(Recurrence, Post operative Pain, seroma and skin infection.)
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post operative complications
Time Frame: 1 month
Superficial skin infection, seroma formation, recurrence and chronic abdominal discomfort.
1 month

Collaborators and Investigators

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

Sponsor

Assiut University

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)

January 1, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

December 26, 2023

First Submitted That Met QC Criteria

December 26, 2023

First Posted (Actual)

January 9, 2024

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

December 26, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mesh in incisional hernia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

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