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CompletedNCT01421602Updated Jul 26, 2018

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

An observational study in Hernia, Inguinal, sponsored by De La Salle University Medical Center. Completed at 1 site in Philippines. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-07-26.

Sponsored by De La Salle University Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
99
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Hernia, Inguinal

Keywords

  • Inguinal Hernia
  • Self-fixating mesh
  • Progrip
  • Hernia Recurrence
  • Mesh, Surgical
  • Recurrence
03

In context

Hernia

1,096 studies on the registry are indexed under Hernia; 132 are open to participants now.

This study's enrollment of 99 is below the median of 120 across 327 observational studies indexed under Hernia.

Browse Hernia studies →

Lead sponsor

De La Salle University Medical Center is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
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

Inclusion criteria

  • Age 18-80 years
  • Informed consent
  • Primary inguinal hernia suitable for open inguinal repair
  • Reducible hernia

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
99 participants (actual)
06

Study locations

1 site
  • De La Salle University Medical Center
    Dasmarinas, Cavite 4114, Philippines
07

References and documents

Publications

  • 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. PubMed 19005611 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 26, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01421602
Lead sponsor
De La Salle University Medical Center
Responsible party
Michael M. Lawenko MD, FPCS (Assistant Professor, De La Salle University Medical Center) — Principal investigator
First posted
Aug 23, 2011
Start date
Sep 2011
Primary completion
Jan 2015
Completion
Dec 2015
Last update
Jul 26, 2018

Study contacts

Michael M Lawenko, MD
principal investigator · De La Salle University Medical Center - Department of Surgery

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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