Mesh Fixation Versus Non Fixation in Laparoscopic Inguinal Hernioplasty

February 12, 2024 updated by: Mina Makram George, Assiut University

Inguinal hernia is one of the most common types of abdominal hernias. Laparoscopic hernioplasty of inguinal hernia is a good alternative to traditional open repairs even in simple unilateral primary inguinal hernia in terms of decrease post operative pain and complications with comparable recurrence rates.Two techniques are described in laparoscopic hernioplasty and have been extensively studied in randomised trials. The totally extraperitoneal (TEP) approach is more widely used than the transabdominal preperitoneal (TAPP) approach.

In this study we will compare between the results of mesh fixation and non fixation as regard operative and postoperative data.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

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:

  • Any male or female above 18 years old that has uncomplicated inguinal hernia

Exclusion Criteria:

  • Patients with contraindications to use laparoscopy as cardiac or immunocompromised patients.
  • Patients who are difficult to follow up.

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: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mesh fixation
Procedure/Surgery: fixation of conventional polypropylene mesh. This group includes patients with fixation of conventional polypropylene mesh.
Procedure: fixation of conventional polypropylene mesh

By fixation of the polyprolene mesh,patients will be divided into two groups:

Group 1 includes patients with fixation of conventional polypropylene mesh. Group 2 includes patients without fixation of the mesh.
Experimental: Non-mesh fixation
Procedure/Surgery: non-fixation of the mesh. This group includes patients without fixation of the mesh.
Procedure: fixation of conventional polypropylene mesh

By fixation of the polyprolene mesh,patients will be divided into two groups:

Group 1 includes patients with fixation of conventional polypropylene mesh. Group 2 includes patients without fixation of the mesh.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparing fixation of conventional polypropylene mesh versus non fixation of 3D max mesh (anatomically oriented mesh) in laparoscopic trans-abdominal properitoneal (TAPP) inguinal hernia repair
Time Frame: Baseline
Comparing fixation of conventional polypropylene mesh versus non fixation of 3D max mesh (anatomically oriented mesh) in laparoscopic transabdominal properitoneal (TAPP) inguinal hernia repair as regard operative and postoperative data.By following-up the patient while admitted post-operatively to check scrotal swelling by examination.After discharge contacting the patient 10 days, 20 days, one month, 2 months, 3 months, 6 months, one year, 2 years to check incidence of recurrence of hernia and return to normal life activities.
Baseline

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Principal Investigator: Mohamed A Rizk, 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)

February 1, 2024

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

December 22, 2023

First Submitted That Met QC Criteria

February 12, 2024

First Posted (Actual)

February 14, 2024

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 12, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • inguinal hernioplasty

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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