Non-Mesh Versus Mesh Method for Inguinal Hernia Repair

Not Applicable

• Conditions: Hernia, Inguinal
• Interventions: Procedure: Mesh Hernia Repair; Procedure: Non-mesh Hernia Repair

• Registration Number: NCT00941941
• Lead Sponsor: Makerere University

Brief Summary

The study aims at establishing the effectiveness of the non-mesh (Desarda) technique for the treatment of primary inguinal hernias at Mulago Hospital in Uganda. First developed and used in India, the Desarda method is reported to offer superior outcomes such as minimal postoperative groin pain and near zero recurrence rates. In comparison to the mesh-based repairs, it is a simple and affordable technique suitable for the resource-constrained communities. It is devoid of complications associated with foreign body implants. Early clinical outcomes which include acute groin pain, time to resumption of normal gait, operative time and complications will be assessed. Participants will be followed at 2 hours, 3 days, 7 days and 14 days postoperatively.

The investigators hypothesize that the mean postoperative acute groin pain score, or the mean postoperative day of return to normal gait is different in adult patients who undergo the non-mesh (Desarda) repair from what it is in those who undergo the mesh (Lichtenstein) technique of hernia repair.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Status Verified: 2009-07
• Study First Submitted: 2009-07-11
• Study First Submitted QC: 2009-07-16
• Last Update Submitted: 2009-07-16
• Study First Posted: 2009-07-20
• Last Update Posted: 2009-07-20
• Primary Completion: 2009-08
• Study Completion: 2009-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

• Aged 18 and above;
• with a primary, reducible inguinal or inguino-scrotal hernia;
• who consent to participate in the study;
• who have a telephone contact.

Exclusion Criteria

• Giant inguino-scrotal hernias;
• Obstructive uropathy or chronic obstructive pulmonary disease;
• Impaired mental state and are unable to give an accurate assessment of the key outcomes of the operation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mesh Hernia Repair	Mesh Hernia Repair	Polypropylene mesh placement
Non-mesh Hernia Repair	Non-mesh Hernia Repair	Reinforcement with a strip of external oblique aponeurosis

Primary Outcome Measures

Name	Time	Method
Acute groin pain after surgery (measured on pain visual analogue scale of 0-10)	2 Weeks
Time (in days) taken to return to normal gait	2 Weeks

Secondary Outcome Measures

Name	Time	Method
Operative time (in Minutes)	2 hours
Complications during and after surgery	2 Weeks

Trial Locations

Locations (1)

Mulago National Referral Hospital; 🇺🇬 Kampala, Central, Uganda