Repair of Inguinal Hernia

July 17, 2024 updated by: Abdelaziz Mohamed Abdelaziz, Sohag University

Outcomes of Laparoscopic Versus Open Repair of Inguinal Hernia

The aim of this study is to compare the outcomes of open versus laparoscopic approaches for inguinal hernia surgery and provide evidence-based guidance to the selection of the most appropriate operative technique.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

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

  • Name: Alaa A Redwan, Prof
  • Phone Number: 01001988455

Study Locations

  • Egypt
      • Sohag, Egypt
        • Recruiting
        • Sohag University Hospital
        • Contact:
          • Magdy M Amin

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

No

Description

Inclusion Criteria:

Male patient > 18 years of age

• Primary groin hernias requiring surgical intervention that are eligible for both open and laparoscopic repair.

Exclusion Criteria:

  • Emergency procedures .

    • ASA score > 2.
    • Irreducible inguinoscrotal hernia .
    • Local or systemic infection .
    • Other abdominal hernias being operated at the same time or planned operated during Follow up.

Previous surgery which has impaired the sensation in the groin area .

  • BMI > 40 kg/m2.
  • Known disease which Impairs central or peripheral nerve function .
  • Concurrent malignant Disease .
  • Chronic pain which requires daily medication . • Mental disorder which requires daily medication .

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Laparoscopic repair of inguinal hernia
Procedure: Laparoscopic repair of inguinal hernia
Laparoscopic repair of inguinal hernia
Active Comparator: Open repair of inguinal hernia
Procedure: Open repair of inguinal hernia
Repair of inguinal hernia by open technique-mesh hernioplasty -

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence in management of inguinal hernia
Time Frame: 6 months after operation
Rate of recurrence in both open and laparoscopic repair of inguinal hernia
6 months after operation

Collaborators and Investigators

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

Sponsor

Sohag 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 (Actual)

June 10, 2024

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

July 17, 2024

First Submitted That Met QC Criteria

July 17, 2024

First Posted (Actual)

July 23, 2024

Study Record Updates

Last Update Posted (Actual)

July 23, 2024

Last Update Submitted That Met QC Criteria

July 17, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-24-06-07MS

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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