IHR: Non-Mesh Versus Mesh Method for Inguinal Hernia Repair

Sponsor

Makerere University (Other)

Overall Status

Unknown status

CT.gov ID

NCT00941941

Collaborator

Mulago Hospital, Uganda (Other)

Enrollment

Location

Arms

Duration (Months)

24.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hernia, Inguinal	Procedure: Non-mesh Hernia Repair Procedure: Mesh Hernia Repair	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

98 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Comparison of Non-mesh (Desarda) and Mesh (Lichtenstein) Methods for Inguinal Hernia Repair at Mulago Hospital: a Double-blind Randomised Controlled Trial

Study Start Date :

May 1, 2009

Anticipated Primary Completion Date :

Aug 1, 2009

Anticipated Study Completion Date :

Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Non-mesh Hernia Repair Reinforcement with a strip of external oblique aponeurosis	Procedure: Non-mesh Hernia 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 Other Names: Desarda repair
Active Comparator: Mesh Hernia Repair Polypropylene mesh placement	Procedure: Mesh Hernia 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. Other Names: Lichtenstein repair

Arm

Intervention/Treatment

Experimental: Non-mesh Hernia Repair

Reinforcement with a strip of external oblique aponeurosis

Procedure: Non-mesh Hernia 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

Other Names:

Desarda repair

Active Comparator: Mesh Hernia Repair

Polypropylene mesh placement

Procedure: Mesh Hernia 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.

Other Names:

Lichtenstein repair

Outcome Measures

Primary Outcome Measures

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

Operative time (in Minutes) [2 hours]
Complications during and after surgery [2 Weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.