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

Not Applicable

Withdrawn

• Conditions: Inguinal Hernia
• Interventions: Procedure: Open Inguinal Hernia Repair With Mesh,the Use of Absorbable Versus Non Absorbable Fixation Sutures

• Registration Number: NCT01467830
• Lead Sponsor: Rambam Health Care Campus

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-30
• Study First Submitted QC: 2011-11-08
• Study First Posted: 2011-11-09
• Status Verified: 2011-12
• Study Start: 2011-12
• Primary Completion: 2013-12
• Study Completion: 2014-03
• Last Update Submitted: 2014-07-03
• Last Update Posted: 2014-07-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
absorbable sutures	Open Inguinal Hernia Repair With Mesh,the Use of Absorbable Versus Non Absorbable Fixation Sutures	patients attributed to that arm, undergoing surgery of Open Inguinal Hernia Repair With Mesh Fixation using absorbable sutures.
non absorbable sutures	Open Inguinal Hernia Repair With Mesh,the Use of Absorbable Versus Non Absorbable Fixation Sutures	patients attributed to that arm, undergoing surgery of Open Inguinal Hernia Repair With Mesh Fixation using non absorbable sutures,this is the method being considered the standard of care thus far.

Primary Outcome Measures

Name	Time	Method
Impact of absorbable sutures in inguinal hernia repair on hernia recurrence and post operative outcome	two years	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

Trial Locations

Locations (1)

Rambam Health Care Campus; 🇮🇱 Haifa, Israel