Non-Mesh Versus Mesh Method for Inguinal Hernia Repair

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2009-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Hernia, Inguinal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Non-mesh Hernia Repair

Reinforcement with a strip of external oblique aponeurosis

Group Type EXPERIMENTAL

Non-mesh Hernia Repair

Intervention Type PROCEDURE

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

Mesh Hernia Repair

Polypropylene mesh placement

Group Type ACTIVE_COMPARATOR

Mesh Hernia Repair

Intervention Type PROCEDURE

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.

Interventions

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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

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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Desarda repair Lichtenstein repair

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No