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

This study is currently recruiting participants.
Verified September 2011 by De La Salle University Medical Center
Sponsor:
Information provided by (Responsible Party):
Michael M. Lawenko MD, DPBS, De La Salle University Medical Center
ClinicalTrials.gov Identifier:
NCT01421602
First received: August 22, 2011
Last updated: September 21, 2011
Last verified: September 2011
  Purpose

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
Hernia, Inguinal

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Study on the Use of a Self Fixating Lightweight Polyester Mesh in Open Inguinal Hernia

Resource links provided by NLM:


Further study details as provided by De La Salle University Medical Center:

Estimated Enrollment: 100
Study Start Date: September 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Detailed 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).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01421602

Locations
Philippines
De La Salle University Medical Center Recruiting
Dasmarinas, Cavite, Philippines, 4114
Contact: Melchor Victor G Frias, MD    63464818000    mgfrias@dlshsi.edu.ph   
Principal Investigator: Michael M Lawenko, MD         
Sub-Investigator: Jesus Versoza, MD         
Sub-Investigator: Renato CA Ocampo, MD         
Sub-Investigator: Mabel Yuga, MD         
Sponsors and Collaborators
De La Salle University Medical Center
Investigators
Principal Investigator: Michael M Lawenko, MD De La Salle University Medical Center - Department of Surgery
  More Information

Publications:
Responsible Party: Michael M. Lawenko MD, DPBS, Assistant Professor, De La Salle University Medical Center
ClinicalTrials.gov Identifier: NCT01421602     History of Changes
Other Study ID Numbers: AKMRC-11-001
Study First Received: August 22, 2011
Last Updated: September 21, 2011
Health Authority: Philippines: National Health Research System

Keywords provided by De La Salle University Medical Center:
Inguinal Hernia
Self-fixating mesh
Progrip
Hernia Recurrence
Mesh, Surgical
Recurrence

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on April 17, 2014