Open Inguinal Hernia Repair With Mesh,the Use of Absorbable Versus Non Absorbable Fixation Sutures

Inguinal Hernia Clinical Trial

Official title:

Open Inguinal Hernia Repair With Mesh,the Use of Absorbable Versus Non Absorbable Fixation Sutures

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01467830
• Other study ID #: absorbable suturesCTIL
• Status: Withdrawn
• Phase: N/A
• First received: October 30, 2011
• Last updated: July 3, 2014
• Start date: December 2011
• Est. completion date: March 2014

Study information

• Verified date: December 2011
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the efficacy of mesh fixation using absorbable versus non-absorbable sutures.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• all patients undergoing initial unilateral Open Inguinal Hernia Repair surgery.

Exclusion Criteria:

• patients having repeated Inguinal Hernia or bilateral Hernia

• patients undergoing laparoscopic surgery.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Intervention

Procedure:
• Open Inguinal Hernia Repair With Mesh,the Use of Absorbable Versus Non Absorbable Fixation Sutures
use of absorbable sutures to fixate mesh inguinal hernia repair.

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa

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	Impact of absorbable sutures in inguinal hernia repair on hernia recurrence and post operative outcome	Absorbable sutures efficacy will be assessed according to:severity of post surgical pain(using NRS-Numerical Rating Scale measure),hernia recurrence (assessed by physical examination during the follow-up period) and other post surgical complications such as nerve entrapment,hematoma and stich granuloma	two years	Yes