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

M

Makerere University

Status

Unknown

Conditions

Hernia, Inguinal

Treatments

Procedure: Non-mesh Hernia Repair
Procedure: Mesh Hernia Repair

Study type

Interventional

Funder types

Other

Identifiers

NCT00941941
2006/HD11/6219U
REC REF 2009-080

Details and patient eligibility

About

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.

Enrollment

98 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

98 participants in 2 patient groups

Non-mesh Hernia Repair
Experimental group
Description:
Reinforcement with a strip of external oblique aponeurosis
Treatment:
Procedure: Non-mesh Hernia Repair
Mesh Hernia Repair
Active Comparator group
Description:
Polypropylene mesh placement
Treatment:
Procedure: Mesh Hernia Repair

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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