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

Terminated

• Conditions: Primary Inguinal Hernia; Unilateral Hernia; Open Surgery
• Interventions: Device: Self-fixating Mesh

• Registration Number: NCT01596049
• Lead Sponsor: Rambam Health Care Campus

Brief Summary

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).

Detailed 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.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-09
• Study First Submitted QC: 2012-05-09
• Study First Posted: 2012-05-10
• Status Verified: 2017-08
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Last Update Submitted: 2017-08-17
• Last Update Posted: 2017-08-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 7

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Percentage of post operative inguinal Hernia recurrence.	2 weeks, 3,6,12,24 months post-operative
Post-operative patient quality of life will be assessed using a validated questionnaire.	2 weeks, 3,6,12,24 months post-operative
Pain will be assessed by NRS (Numerical Rating Scale)	2 weeks, 3,6,12,24 months post-operative
Post-operative complications will be assessed using a validated questionnaire.	2 weeks, 3,6,12,24 months post-operative

Trial Locations

Locations (2)

Rambam Health Care Campus; 🇮🇱 Haifa, Israel

Rambam health care campus; 🇮🇱 Hifa, Israel