The Efficacy of a Self-fixating Mesh in Unilateral Open Inguinal Hernia Repair

Rambam Health Care Campus

Status: Terminated

Conditions: Unilateral Hernia; Primary Inguinal Hernia; Open Surgery

Treatments: Device: Self-fixating Mesh

Study type: Observational

Funder types: Other

Identifiers

NCT01596049

hernia313-11-RMBCTIL

Details and patient eligibility

About

This study's objective is to assess the efficacy of a Self-fixating mesh in the surgical repair of unilateral inguinal hernia, which is becoming the new standard of care in open surgical repair of inguinal hernia.

The study design is interventional, enrolling 300 patients above 18 years of age, admitted for elective repair in the surgical department of Rambam Medical Health Care Campus, an academic medical center.

The study will assess several outcomes including post-surgical pain, recurrence, quality of life and post surgical complications (e.g. wound infection, the formation of hematoma or seroma, etc).

Full description

This study's objective is to assess the efficacy of a Self-fixating mesh in the surgical repair of unilateral inguinal hernia, which is becoming the new standard of care in open surgical repair of inguinal hernia.

The study design is interventional, enrolling 300 patients above 18 years of age, admitted for elective repair in the surgical department of Rambam Medical Health Care Campus, an academic medical center.

The study will assess several outcomes including post-surgical pain, recurrence, quality of life and post surgical complications (e.g. wound infection, the formation of hematoma or seroma, etc).

The data will be compared to the literature and will be statistically analysed. The follow-up for each patient will be two years.

Enrollment: 7 patients

Sex: Male

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients undergoing primary unilateral open Inguinal Hernia Repair .
• patients undergoing elective surgery.
• above the age of 18 years old

Exclusion criteria

• patients having repeated Inguinal Hernia.
• patients having bilateral Hernia.
• patients undergoing laparoscopic surgery.
• patients undergoing non-elective surgery.

Trial design

7 participants in 1 patient group

Self-fixating Mesh

Description:

patients attributed to that arm, undergoing surgery of open inguinal unilateral hernia repair, using Self-fixating Mesh which is acceptable in the literature.

Treatment:

Device: Self-fixating Mesh