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

Primary Purpose

Hernia, Inguinal

Status
Unknown status
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
Non-mesh Hernia Repair
Mesh Hernia Repair
Sponsored by
Makerere University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia, Inguinal focused on measuring Inguinal, Hernia, Hernia-repair, Non-mesh, Mesh, Desarda, Lichtenstein

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Mulago National Referral Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Non-mesh Hernia Repair

Mesh Hernia Repair

Arm Description

Reinforcement with a strip of external oblique aponeurosis

Polypropylene mesh placement

Outcomes

Primary Outcome Measures

Acute groin pain after surgery (measured on pain visual analogue scale of 0-10)
Time (in days) taken to return to normal gait

Secondary Outcome Measures

Operative time (in Minutes)
Complications during and after surgery

Full Information

First Posted
July 11, 2009
Last Updated
July 16, 2009
Sponsor
Makerere University
Collaborators
Mulago Hospital, Uganda
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1. Study Identification

Unique Protocol Identification Number
NCT00941941
Brief Title
Non-Mesh Versus Mesh Method for Inguinal Hernia Repair
Acronym
IHR
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 Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
May 2009 (undefined)
Primary Completion Date
August 2009 (Anticipated)
Study Completion Date
September 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Makerere University
Collaborators
Mulago Hospital, Uganda

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Inguinal
Keywords
Inguinal, Hernia, Hernia-repair, Non-mesh, Mesh, Desarda, Lichtenstein

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
98 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Non-mesh Hernia Repair
Arm Type
Experimental
Arm Description
Reinforcement with a strip of external oblique aponeurosis
Arm Title
Mesh Hernia Repair
Arm Type
Active Comparator
Arm Description
Polypropylene mesh placement
Intervention Type
Procedure
Intervention Name(s)
Non-mesh Hernia Repair
Other Intervention Name(s)
Desarda repair
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Mesh Hernia Repair
Other Intervention Name(s)
Lichtenstein repair
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acute groin pain after surgery (measured on pain visual analogue scale of 0-10)
Time Frame
2 Weeks
Title
Time (in days) taken to return to normal gait
Time Frame
2 Weeks
Secondary Outcome Measure Information:
Title
Operative time (in Minutes)
Time Frame
2 hours
Title
Complications during and after surgery
Time Frame
2 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Manyilirah
Organizational Affiliation
Makerere University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alex Upoki
Organizational Affiliation
Makerere University
Official's Role
Study Chair
Facility Information:
Facility Name
Mulago National Referral Hospital
City
Kampala
State/Province
Central
Country
Uganda

12. IPD Sharing Statement

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Non-Mesh Versus Mesh Method for Inguinal Hernia Repair

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