Back to resultsOpen Inguinal Hernia Repair With Mesh,the Use of Absorbable Versus Non Absorbable Fixation Sutures
Primary Purpose
Inguinal Hernia
Status
Withdrawn
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Open Inguinal Hernia Repair With Mesh,the Use of Absorbable Versus Non Absorbable Fixation Sutures
Sponsored by
About this trial
This is an interventional treatment trial for Inguinal Hernia focused on measuring absorbable sutures efficacy, reducing Adverse effect to be caused from surgery, Inguinal Hernia repair with mesh
Eligibility 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.
Sites / Locations
- Rambam Health Care Campus
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
absorbable sutures
non absorbable sutures
Arm Description
patients attributed to that arm, undergoing surgery of Open Inguinal Hernia Repair With Mesh Fixation using 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.
Outcomes
Primary Outcome Measures
Impact of absorbable sutures in inguinal hernia repair on hernia recurrence and post operative outcome
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 Outcome Measures
Full Information
NCT ID
NCT01467830
First Posted
October 30, 2011
Last Updated
July 3, 2014
Sponsor
Rambam Health Care Campus
1. Study Identification
Unique Protocol Identification Number
NCT01467830
Brief Title
Open Inguinal Hernia Repair With Mesh,the Use of Absorbable Versus Non Absorbable Fixation Sutures
Official Title
Open Inguinal Hernia Repair With Mesh,the Use of Absorbable Versus Non Absorbable Fixation Sutures
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Withdrawn
Study Start Date
December 2011 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
March 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rambam Health Care Campus
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the efficacy of mesh fixation using absorbable versus non-absorbable sutures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia
Keywords
absorbable sutures efficacy, reducing Adverse effect to be caused from surgery, Inguinal Hernia repair with mesh
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
absorbable sutures
Arm Type
Experimental
Arm Description
patients attributed to that arm, undergoing surgery of Open Inguinal Hernia Repair With Mesh Fixation using absorbable sutures.
Arm Title
non absorbable sutures
Arm Type
Other
Arm Description
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 Type
Procedure
Intervention Name(s)
Open Inguinal Hernia Repair With Mesh,the Use of Absorbable Versus Non Absorbable Fixation Sutures
Intervention Description
use of absorbable sutures to fixate mesh inguinal hernia repair.
Primary Outcome Measure Information:
Title
Impact of absorbable sutures in inguinal hernia repair on hernia recurrence and post operative outcome
Description
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
Time Frame
two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adel Abu_salih, M.D
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam Health Care Campus
City
Haifa
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Open Inguinal Hernia Repair With Mesh,the Use of Absorbable Versus Non Absorbable Fixation Sutures
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