Non-Mesh Versus Mesh Method for Inguinal Hernia Repair (IHR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00941941
Recruitment Status : Unknown
Verified July 2009 by Makerere University.
Recruitment status was:  Active, not recruiting
First Posted : July 20, 2009
Last Update Posted : July 20, 2009
Mulago Hospital, Uganda
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Hernia, Inguinal Procedure: Non-mesh Hernia Repair Procedure: Mesh Hernia Repair Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated 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 2009
Estimated Primary Completion Date : August 2009
Estimated Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

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 Name: 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 Name: Lichtenstein repair

Primary Outcome Measures :
  1. Acute groin pain after surgery (measured on pain visual analogue scale of 0-10) [ Time Frame: 2 Weeks ]
  2. Time (in days) taken to return to normal gait [ Time Frame: 2 Weeks ]

Secondary Outcome Measures :
  1. Operative time (in Minutes) [ Time Frame: 2 hours ]
  2. Complications during and after surgery [ Time Frame: 2 Weeks ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00941941

Mulago National Referral Hospital
Kampala, Central, Uganda
Sponsors and Collaborators
Makerere University
Mulago Hospital, Uganda
Principal Investigator: William Manyilirah Makerere University
Study Chair: Alex Upoki Makerere University

Responsible Party: William Manyilirah, Makerere University Identifier: NCT00941941     History of Changes
Other Study ID Numbers: 2006/HD11/6219U
REC REF 2009-080
First Posted: July 20, 2009    Key Record Dates
Last Update Posted: July 20, 2009
Last Verified: July 2009

Keywords provided by Makerere University:

Additional relevant MeSH terms:
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal