Overview

This trial is active, not recruiting.

Condition hernia, inguinal
Treatments non-mesh hernia repair, mesh hernia repair
Sponsor Makerere University
Collaborator Mulago Hospital, Uganda
Start date May 2009
End date August 2009
Trial size 98 participants
Trial identifier NCT00941941, 2006/HD11/6219U, REC REF 2009-080

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Reinforcement with a strip of external oblique aponeurosis
non-mesh hernia repair Desarda repair
Non-mesh method for treatment of inguinal hernia without the use of a foreign material (mesh). It involves reinforcement of the weakened posterior wall of inguinal canal with a small, undetached strip of aponeurotic tissue of external
(Active Comparator)
Polypropylene mesh placement
mesh hernia repair Lichtenstein repair
Mesh method for treatment of inguinal hernias by use of an implant (mesh) to reinforce the weakened posterior wall of the inguinal canal. The mesh is made of polypropylene material.

Primary Outcomes

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

Secondary Outcomes

Measure
Operative time (in Minutes)
time frame: 2 hours
Complications during and after surgery
time frame: 2 Weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Comparison of Non-mesh (Desarda) and Mesh (Lichtenstein) Methods for Inguinal Hernia Repair at Mulago Hospital: a Double-blind Randomised Controlled Trial
Principal investigator William Manyilirah
Trial information was received from ClinicalTrials.gov and was last updated in July 2009.
Information provided to ClinicalTrials.gov by Makerere University.