A Prospective Observational Study on the Use of a Self Fixating Lightweight Polyester Mesh in Open Inguinal Hernia
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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 |
| 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) |
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 |
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
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| 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 | |
| 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 May 19, 2013