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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Makerere University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Mulago Hospital, Uganda
Information provided by:
Makerere University
ClinicalTrials.gov Identifier:
NCT00941941
First received: July 11, 2009
Last updated: July 16, 2009
Last verified: July 2009
History of Changes
  Purpose

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 Intervention
Hernia, Inguinal
 Procedure: Non-mesh Hernia Repair
Procedure: Mesh Hernia Repair

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Hernia
U.S. FDA Resources

Further study details as provided by Makerere University:

Primary Outcome Measures:
  • Acute groin pain after surgery (measured on pain visual analogue scale of 0-10) [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
  • Time (in days) taken to return to normal gait [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Operative time (in Minutes) [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
  • Complications during and after surgery [ Time Frame: 2 Weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 98
Study Start Date: May 2009
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00941941

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

No publications provided

Responsible Party: William Manyilirah, Makerere University
ClinicalTrials.gov Identifier: NCT00941941     History of Changes
Other Study ID Numbers: 2006/HD11/6219U, REC REF 2009-080
Study First Received: July 11, 2009
Last Updated: July 16, 2009
Health Authority: Uganda: National Council for Science and Technology

Keywords provided by Makerere University:
Inguinal
Hernia
Hernia-repair
Non-mesh
 Mesh
Desarda
Lichtenstein

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

ClinicalTrials.gov processed this record on May 16, 2013