A Prospective Observational Study on the Use of a Self Fixating Lightweight Polyester Mesh in Open Inguinal Hernia

Hernia, Inguinal Clinical Trial

Official title:

A Prospective Observational Study on the Use of a Self Fixating Lightweight Polyester Mesh in Open Inguinal Hernia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01421602
• Other study ID #: AKMRC-11-001
• Status: Completed
• Start date: September 2011
• Est. completion date: December 2015

Study information

• Verified date: July 2018
• Source: De La Salle University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will hypothesize that the use of a self fixating lightweight mesh in open inguinal repair is feasible in the Philippine setting. It will result in a comparable recurrence rate as published for the traditional Lichtenstein approach.

Description:

The specific aim of this study is to assess the feasibility of using a self fixating lightweight mesh in open inguinal hernia under both under regional and local anesthesia in the Philippines. The primary endpoint of which is to assess the recurrence rate at 2 years (with an interim analysis 1 year after the procedure). Secondary endpoints would be to gather data with regards to postoperative pain, post operative surgical complications, wound healing complications, operating factors (mesh deployment time, total operating time), hernia factors (type and size of inguinal hernia).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: December 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age 18-80 years

• Informed consent

• Primary inguinal hernia suitable for open inguinal repair

• Reducible hernia

Exclusion Criteria:

• Incarcerated non reducible hernias

• Bleeding disorders

• Patients below 18 (lower age limit) and above 80 (upper age limit) years old

• Hernia defects of greater than 4 cm

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal

Locations

Country	Name	City	State
Philippines	De La Salle University Medical Center	Dasmarinas	Cavite

Sponsors (1)

Lead Sponsor	Collaborator
De La Salle University Medical Center

Country where clinical trial is conducted

Philippines, 

References & Publications (1)

Chastan P. Tension-free open hernia repair using an innovative self-gripping semi-resorbable mesh. Hernia. 2009 Apr;13(2):137-42. doi: 10.1007/s10029-008-0451-4. Epub 2008 Nov 13. — View Citation