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

De La Salle University Medical Center

Status: Completed

Conditions: Hernia, Inguinal

Study type: Observational

Funder types: Other

Identifiers

NCT01421602

AKMRC-11-001

Details and patient eligibility

About

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.

Full 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).

Enrollment: 99 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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