Comparison of Whole Mesh and Split Mesh Use in Laparoscopic Inguinal Hernia Repair

July 19, 2022 updated by: Erol Aydın, Istanbul Training and Research Hospital

Prospective Comparison of Whole Mesh and Split Mesh Use in Patient Groups Undergoing Laparoscopic Inguinal Hernia Repair

At least 80 patients who will undergo laparoscopic inguinal hernia repair surgery will be randomized into 2 groups. For the patients in the first group, the whole mesh will be laid on the area without being fixed. The patients in the second group will be given a mesh of the same size, but partially divided horizontally and wrapped around the spermatic cord. Demographic data of patients in both groups, quality of life data(Carolinas Comfort Scale) at postoperative 1st, 7th, 30th, 3rd and 6th months, postoperative pain (VAS values), clinical seroma rate, recurrence and other complications will be monitored. When the desired number of patients and follow-up period are reached, the data in the 2 groups will be compared.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

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 Locations

  • Turkey
      • Istanbul, Turkey
        • Recruiting
        • Istanbul Training and Research Hospital
        • 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical or/and radiological diagnosed primary inguinal hernia
  • TEP or TAPP surgical methods

Exclusion Criteria:

  • Recurrent hernias
  • Patients with previous groin operations on same side
  • Pregnant women
  • Patients who did not accept to participate in the study
  • ASA score of 3 or higher,

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Whole Mesh
For the patients in the first group, the whole patch will be laid on the area without being fixed.
Procedure: Split Mesh
TEP repair of inguinal hernias using either split or whole mesh
Other Names:
  • Whole mesh
Active Comparator: Split Mesh
The patients in the second group will be given a patch of the same size, but partially divided horizontally and wrapped around the spermatic cord.
Procedure: Split Mesh
TEP repair of inguinal hernias using either split or whole mesh
Other Names:
  • Whole mesh

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Carolinas Comfort Scale values
Time Frame: 6 month
Differences in postoperative pain and quality of life(Carolinas Comfort Scale at first month) in patients who use whole meshes and those who use split meshes.
6 month
Recurrence rates
Time Frame: 6 month
Differences in recurrence rates in patients who use whole meshes and those who use split meshes.
6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence rates
Time Frame: 6 month
Difference in recurrence rates at 6 months in patients who use whole meshes and those who use split meshes.
6 month

Collaborators and Investigators

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

Sponsor

Istanbul Training and Research Hospital

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 (Actual)

June 16, 2022

Primary Completion (Anticipated)

May 16, 2023

Study Completion (Anticipated)

June 16, 2023

Study Registration Dates

First Submitted

May 20, 2022

First Submitted That Met QC Criteria

June 11, 2022

First Posted (Actual)

June 15, 2022

Study Record Updates

Last Update Posted (Actual)

July 20, 2022

Last Update Submitted That Met QC Criteria

July 19, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 569874

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.

Clinical Trials on Hernia, Inguinal

Clinical Trials on Split Mesh

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Singapore

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe