Back to resultsIsolation of the Spermatic Cord in Mesh Inguinal Hernia Repair
Primary Purpose
Inguinal Hernia
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Isolation of the spermatic cord from mesh
Sponsored by
About this trial
This is an interventional prevention trial for Inguinal Hernia focused on measuring Inguinal hernia repair, Mesh, Groin pain, Testicular pain
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of a primary unilateral inguinal hernia
Exclusion Criteria:
- Medically unfit for surgical repair
Sites / Locations
- Chatham Kent Health AllianceRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Spermatic Cord in contact with mesh
Spermatic Cord is isolated from the mesh
Arm Description
Where the spermatic cord has been allowed to remain in contact with the mesh.
The inguinal ligament is interposed between the cord and the mesh and then repaired. This isolates the cord from the mesh and the splinting function of the overlying inguinal ligament.
Outcomes
Primary Outcome Measures
Evaluation of groin or testicular pain lasting longer than 3 months postoperatively.
All patients will be evaluated using the Carolina's Comfort Scale
Secondary Outcome Measures
Number of patients with adverse events.
Full Information
NCT ID
NCT01391455
First Posted
July 6, 2011
Last Updated
July 11, 2011
Sponsor
Chatham Kent Health Alliance
1. Study Identification
Unique Protocol Identification Number
NCT01391455
Brief Title
Isolation of the Spermatic Cord in Mesh Inguinal Hernia Repair
Official Title
Isolation of the Spermatic Cord Following Mesh Inguinal Hernia Repair
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
August 2012 (Anticipated)
Study Completion Date
August 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Chatham Kent Health Alliance
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
There are in excess of 1 million operations performed annually to repair inguinal hernias, mostly in the male population. Unfortunately, some patients continue to suffer both groin or testicular pain for varying lengths of time postoperatively. This can lead to a severe degradation of the patient's lifestyle, work habits and sexual function. The origin of the pain is felt to be secondary to the inflammatory reaction caused by the mesh. This also involves the spermatic cord and its structures, leading to orchidinia and possibly azospermia.
Detailed Description
In this prospective randomized trial, male patients with a primary symptomatic unilateral inguinal hernia will be admitted to the trial. All patients must be over 21 years of age. In order to avoid inguinal nerve entrapment or damage by mesh fixation sutures Covidien Parietene ProGrip mesh will be employed. This mesh does not require fixation. Standard open inguinal hernia repair will take place with nerve preservation, as day surgery cases. In the randomized portion of the study, the mesh will be placed as usual along the posterior wall of the inguinal canal, however the inguinal ligament will be interposed between the mesh and the spermatic cord, thus isolating the cord from intimate contact with the mesh, and a reduction in postoperative inflammatory changes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia
Keywords
Inguinal hernia repair, Mesh, Groin pain, Testicular pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Spermatic Cord in contact with mesh
Arm Type
No Intervention
Arm Description
Where the spermatic cord has been allowed to remain in contact with the mesh.
Arm Title
Spermatic Cord is isolated from the mesh
Arm Type
Experimental
Arm Description
The inguinal ligament is interposed between the cord and the mesh and then repaired. This isolates the cord from the mesh and the splinting function of the overlying inguinal ligament.
Intervention Type
Procedure
Intervention Name(s)
Isolation of the spermatic cord from mesh
Intervention Description
The spermatic cord is isolated from the mesh employed to repair an inguinal hernia following standard open repair.
Primary Outcome Measure Information:
Title
Evaluation of groin or testicular pain lasting longer than 3 months postoperatively.
Description
All patients will be evaluated using the Carolina's Comfort Scale
Time Frame
1 year postoperatively
Secondary Outcome Measure Information:
Title
Number of patients with adverse events.
Time Frame
1 year
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of a primary unilateral inguinal hernia
Exclusion Criteria:
Medically unfit for surgical repair
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John A Morrison, MD; FRCS(C)
Phone
519 352 0503
Email
hernia@johnmorrisonmd.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John A Morrison, MD;FRCS(C)
Organizational Affiliation
Chatham Kent Health Alliance
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chatham Kent Health Alliance
City
Chatham
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John A Morrison, MD;FRCS(C)
Phone
519 352 0503
Email
hernia@johnmorrisonmd.com
First Name & Middle Initial & Last Name & Degree
Gary Tithecott, MD;FRCP(C)
Phone
519 3526400
Email
gtithecott@ckha.on.ca
First Name & Middle Initial & Last Name & Degree
John A Morrison, MD;FRSC(C)
12. IPD Sharing Statement
Learn more about this trial
Isolation of the Spermatic Cord in Mesh Inguinal Hernia Repair
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