Prophylactic Ilioinguinal Neurectomy During Open Tension-Free Inguinal Hernia Repair

March 22, 2024 updated by: Yasser Ali Orban, Zagazig University

Prophylactic Ilioinguinal Neurectomy During Open Tension-Free Inguinal Hernia Repair for Prevention of Chronic Postoperative Pain

postoperative chronic inguinal pain is a common postoperative complication after open inguinal hernia repair.

Chronic inguinal pain is a common complication following open inguinal hernia repair. Ilioinguinal nerve entrapment is a common cause of this chronic pain which may adversely affect the patients' life. Ilioinguinal neurectomy seems to be beneficial in preventing such pain, but it carries the risk for numbness and hypoesthesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

196

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 Locations

  • Egypt
      • Zagazig, Egypt, 7120730
        • yasmine Hegab

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

- the study included all adult patients operated on for unilateral inguinal hernia by Lichtenstein tension-free mesh hernioplasty with or without ilioinguinal neurectomy.

Exclusion Criteria:

  • patients with recurrent inguinal hernia, bilateral inguinal hernia repair, or huge inguinoscrotal hernia were excluded. Diabetic patients as well as, patients with suspected inguinal hernia recurrence at the time of the questionnaire were excluded.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: inguinal hernioplasty with ilioinguinal nerve preservation
Experimental: inguinal hernioplasty with ilioinguinal nerve section
Procedure: ilioinguinal nerve section
patients operated on by open inguinal hernioplasty with ilioinguinal neurectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
detect postoperative pain using short form inguinal pain questionnaire
Time Frame: 3 months following operation then continous
ask the patient for presence of postoperative pain using short form inguinal pain questionnaire
3 months following operation then continous

Collaborators and Investigators

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

Sponsor

Zagazig University

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)

January 1, 2022

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

March 16, 2024

First Submitted That Met QC Criteria

March 22, 2024

First Posted (Actual)

March 25, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2024

Last Update Submitted That Met QC Criteria

March 22, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ilioinguinal Neurectomy

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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