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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
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease
Hernia, Inguinal

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).

Study Design

Study Type : Observational
Estimated Enrollment : 100 participants
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
Study Start Date : September 2011
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: August 23, 2011    Key Record Dates
Last Update Posted: September 23, 2011
Last Verified: September 2011

Keywords provided by Michael M. Lawenko MD, DPBS, 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