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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01421602
Other study ID # AKMRC-11-001
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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

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