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

Open Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01596049
• Other study ID #: hernia313-11-RMBCTIL
• Status: Terminated
• Phase: N/A
• First received: May 9, 2012
• Last updated: August 17, 2017
• Start date: May 2012
• Est. completion date: August 2017

Study information

• Verified date: August 2017
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Open Surgery
• Primary Inguinal Hernia
• Unilateral Hernia

Intervention

Device:
• Self-fixating Mesh
Using Self-fixating Mesh for Inguinal Hernia Repair

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa
Israel	Rambam health care campus	Hifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

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