Open Inguinal Hernia Repair With Mesh,the Use of Absorbable Versus Non Absorbable Fixation Sutures
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Rambam Health Care Campus
- Locations
- 1
- Primary Endpoint
- Impact of absorbable sutures in inguinal hernia repair on hernia recurrence and post operative outcome
Study Overview
Brief Summary
The purpose of this study is to determine the efficacy of mesh fixation using absorbable versus non-absorbable sutures.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
absorbable sutures
patients attributed to that arm, undergoing surgery of Open Inguinal Hernia Repair With Mesh Fixation using absorbable sutures.
Intervention: Open Inguinal Hernia Repair With Mesh,the Use of Absorbable Versus Non Absorbable Fixation Sutures (Procedure)
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.
Intervention: Open Inguinal Hernia Repair With Mesh,the Use of Absorbable Versus Non Absorbable Fixation Sutures (Procedure)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported