Clinical Trial: Non-Mesh Versus Mesh Method for Inguinal Hernia Repair

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

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

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 Summary:
Sponsor: Makerere University

Current Primary Outcome:

  • 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 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Makerere University

Dates:
Date Received: July 11, 2009
Date Started: May 2009
Date Completion: September 2009
Last Updated: July 16, 2009
Last Verified: July 2009