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

This study is currently recruiting participants.
Verified December 2011 by Rambam Health Care Campus
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01467830
First received: October 30, 2011
Last updated: December 12, 2011
Last verified: December 2011
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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:

MedlinePlus related topics: Hernia
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 60
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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01467830

Contacts
Contact: Adel Abu_Salih, M.D 972-4-8541308 a_abu_salih@rambam.health.gov.il
Contact: Haim Gilshtein, M.D h_gilshtein@rambam.health.gov.il

Locations
Israel
Rambam Health Care Campus Recruiting
Haifa, Israel
Contact: Adel Abu_Salih, M.D     972-4-8541308     a_abu_salih@rambam.health.gov.il    
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Adel Abu_salih, M.D Rambam Health Care Campus
  More Information

No publications provided

Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01467830     History of Changes
Other Study ID Numbers: absorbable suturesCTIL
Study First Received: October 30, 2011
Last Updated: December 12, 2011
Health Authority: Israel: Ethics Commission

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

ClinicalTrials.gov processed this record on May 16, 2013