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

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.

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Key information

Conditions

Hernia, Inguinal Disease Attributes Hernia Hernia, Abdominal Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

De La Salle University Medical Center

Dasmariñas, Cavite, 4114, Philippines

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

De La Salle University Medical Center

Other

Registry information

Important dates

Study start: 2011
Primary completion: 2015
Study completion: 2015
First posted: Aug 23, 2011
Registry last updated: Jul 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed