A Prospective Observational Study on the Use of a Self Fixating Lightweight Polyester Mesh in Open Inguinal Hernia
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ClinicalTrials.gov Identifier: NCT01421602
Recruitment Status : Unknown
Verified September 2011 by Michael M. Lawenko MD, DPBS, De La Salle University Medical Center. Recruitment status was: Recruiting
First Posted : August 23, 2011
Last Update Posted : September 23, 2011
De La Salle University Medical Center
Information provided by (Responsible Party):
Michael M. Lawenko MD, DPBS, De La Salle University Medical Center
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.
Condition or disease
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).
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Ages Eligible for Study:
18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Potential study subjects will be patients who are:
18 - 80 years old; Has confirmed with the informed consent; Has a primary inguinal hernia (either unilateral or bilateral) which is reducible and amenable to local or regional hernia repair
Age 18-80 years
Primary inguinal hernia suitable for open inguinal repair
Incarcerated non reducible hernias
Patients below 18 (lower age limit) and above 80 (upper age limit) years old