Clinical Trials Directory

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UnknownNCT00941941

Non-Mesh Versus Mesh Method for Inguinal Hernia Repair

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
98 (estimated)
Sponsor
Makerere University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURENon-mesh Hernia RepairNon-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
PROCEDUREMesh Hernia RepairMesh 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.

Timeline

Start date
2009-05-01
Primary completion
2009-08-01
Completion
2009-09-01
First posted
2009-07-20
Last updated
2009-07-20

Locations

1 site across 1 country: Uganda

Source: ClinicalTrials.gov record NCT00941941. Inclusion in this directory is not an endorsement.