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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01467830
First Posted: November 9, 2011
Last Update Posted: July 4, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rambam Health Care Campus
  Purpose
The purpose of this study is to determine the efficacy of mesh fixation using absorbable versus non-absorbable sutures.

Condition Intervention
Inguinal Hernia Procedure: Open Inguinal Hernia Repair With Mesh,the Use of Absorbable Versus Non Absorbable Fixation Sutures

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Open Inguinal Hernia Repair With Mesh,the Use of Absorbable Versus Non Absorbable Fixation Sutures

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome 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


Enrollment: 0
Study Start Date: December 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01467830


Locations
Israel
Rambam Health Care Campus
Haifa, Israel
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Adel Abu_salih, M.D Rambam Health Care Campus
  More Information

Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01467830     History of Changes
Other Study ID Numbers: absorbable suturesCTIL
First Submitted: October 30, 2011
First Posted: November 9, 2011
Last Update Posted: July 4, 2014
Last Verified: December 2011

Keywords provided by Rambam Health Care Campus:
absorbable sutures efficacy
reducing Adverse effect to be caused from surgery
Inguinal Hernia repair with mesh

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal