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

The Efficacy of a Self-fixating Mesh in Unilateral Open Inguinal Hernia Repair, in Comparison to the Standard Treatment in the Literature

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).

Study Overview

• Status: Terminated
• Conditions: Open Surgery; Primary Inguinal Hernia; Unilateral Hernia
• Intervention / Treatment: Device: Self-fixating Mesh

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 Type: Observational
• Enrollment (Actual): 7

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Rambam Health Care Campus
  • Hifa, Israel
    • Rambam Health Care Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

patients who are undergoing Inguinal Hernia Repair Surgery.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: Self-fixating Mesh; Using Self-fixating Mesh for Inguinal Hernia Repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus
• Investigators: Principal Investigator: Adel Abu_Salih, M.D, Rambam Health Care Campus, Haifa, Israel

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: May 9, 2012
• First Submitted That Met QC Criteria: May 9, 2012
• First Posted (Estimate): May 10, 2012

Study Record Updates

• Last Update Posted (Actual): August 22, 2017
• Last Update Submitted That Met QC Criteria: August 17, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: hernia313-11-RMBCTIL