NCT01421602

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 23, 2011

Completed
9 days until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

July 26, 2018

Status Verified

July 1, 2018

Enrollment Period

3.3 years

First QC Date

August 22, 2011

Last Update Submit

July 25, 2018

Conditions

Hernia, Inguinal

Keywords

Inguinal HerniaSelf-fixating meshProgripHernia RecurrenceMesh, SurgicalRecurrence

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

De La Salle University Medical Center

Dasmariñas, Cavite, 4114, Philippines

Location

Related Publications (1)

  • 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.

    PMID: 19005611RESULT

MeSH Terms

Conditions

Hernia, InguinalRecurrence

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Study Officials

  • Michael M Lawenko, MD

    De La Salle University Medical Center - Department of Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 22, 2011

First Posted

August 23, 2011

Study Start

September 1, 2011

Primary Completion

January 1, 2015

Study Completion

December 1, 2015

Last Updated

July 26, 2018

Record last verified: 2018-07

Locations

PH(1)