Open Inguinal Hernia Repair With Mesh,the Use of Absorbable Versus Non Absorbable Fixation Sutures
Overview
The purpose of this study is to determine the efficacy of mesh fixation using absorbable versus non-absorbable sutures.
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Single (Participant)
- Study Primary Completion Date: December 2013
Interventions
- 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.
Arms, Groups and Cohorts
- Experimental: absorbable sutures
- patients attributed to that arm, undergoing surgery of Open Inguinal Hernia Repair With Mesh Fixation using absorbable sutures.
- Other: non absorbable 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.
Clinical Trial Outcome Measures
Primary Measures
- Impact of absorbable sutures in inguinal hernia repair on hernia recurrence and post operative outcome
- Time Frame: 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
Participating in This Clinical Trial
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.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 90 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Rambam Health Care Campus
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Adel Abu_salih, M.D, Principal Investigator, Rambam Health Care Campus
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