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

July 3, 2014 updated by: Rambam Health Care Campus
The purpose of this study is to determine the efficacy of mesh fixation using absorbable versus non-absorbable sutures.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel
        • Rambam Health Care Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: absorbable sutures
patients attributed to that arm, undergoing surgery of Open Inguinal Hernia Repair With Mesh Fixation using absorbable sutures.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Investigators

  • Principal Investigator: Adel Abu_salih, M.D, Rambam Health Care Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

March 1, 2014

Study Registration Dates

First Submitted

October 30, 2011

First Submitted That Met QC Criteria

November 8, 2011

First Posted (Estimate)

November 9, 2011

Study Record Updates

Last Update Posted (Estimate)

July 4, 2014

Last Update Submitted That Met QC Criteria

July 3, 2014

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • absorbable suturesCTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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