Non-Mesh Versus Mesh Method for Inguinal Hernia Repair

Hernia, Inguinal Clinical Trial

— 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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00941941
• Other study ID #: 2006/HD11/6219U
• Secondary ID: REC REF 2009-080
• Status: Unknown status
• Phase: N/A
• First received: July 11, 2009
• Last updated: July 16, 2009
• Start date: May 2009
• Est. completion date: September 2009

Study information

• Verified date: July 2009
• Source: Makerere University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 98
• Est. completion date: September 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal

Intervention

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
• 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.

Locations

Country	Name	City	State
Uganda	Mulago National Referral Hospital	Kampala	Central

Sponsors (2)

Lead Sponsor	Collaborator
Makerere University	Mulago Hospital, Uganda

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute groin pain after surgery (measured on pain visual analogue scale of 0-10)		2 Weeks
Primary	Time (in days) taken to return to normal gait		2 Weeks
Secondary	Operative time (in Minutes)		2 hours
Secondary	Complications during and after surgery		2 Weeks