NCT00941941

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2009

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 20, 2009

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

July 20, 2009

Status Verified

July 1, 2009

Enrollment Period

3 months

First QC Date

July 11, 2009

Last Update Submit

July 16, 2009

Conditions

Hernia, Inguinal

Keywords

InguinalHerniaHernia-repairNon-meshMeshDesardaLichtenstein

Outcome Measures

Primary Outcomes (2)

  • Acute groin pain after surgery (measured on pain visual analogue scale of 0-10)

    2 Weeks

  • Time (in days) taken to return to normal gait

    2 Weeks

Secondary Outcomes (2)

  • Operative time (in Minutes)

    2 hours

  • Complications during and after surgery

    2 Weeks

Study Arms (2)

Non-mesh Hernia Repair

EXPERIMENTAL

Reinforcement with a strip of external oblique aponeurosis

Procedure: Non-mesh Hernia Repair

Mesh Hernia Repair

ACTIVE COMPARATOR

Polypropylene mesh placement

Procedure: Mesh Hernia Repair

Interventions

Non-mesh Hernia RepairPROCEDURE

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

Also known as: Desarda repair
Non-mesh Hernia Repair
Mesh Hernia RepairPROCEDURE

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.

Also known as: Lichtenstein repair
Mesh Hernia Repair

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mulago National Referral Hospital

Kampala, Central Region, Uganda

Location

MeSH Terms

Conditions

Hernia, InguinalHernia

Condition Hierarchy (Ancestors)

Hernia, AbdominalPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • William Manyilirah

    Makerere University

    PRINCIPAL INVESTIGATOR

  • Alex Upoki

    Makerere University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 11, 2009

First Posted

July 20, 2009

Study Start

May 1, 2009

Primary Completion

August 1, 2009

Study Completion

September 1, 2009

Last Updated

July 20, 2009

Record last verified: 2009-07

Locations

UG(1)