TEP Versus Open Repair of Sportsman's Hernia (sports hernia)
Primary Purpose
Chronic Pain, Bone Marrow Oedema
Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
open repair
endoscopic TEP repair
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring sports hernia, sportsman's hernia, chronic groin pain, open minimal repair, totally extraperitoneal endoscopic technique
Eligibility Criteria
Inclusion Criteria:
- males/females professional or non-professional athletes
- age 18-50 years
- unilateral or bilateral groin pain lasting > 6 weeks
- physical examination and MRI indicating sportsman's hernia
- pain above inguinal ligament in the deep inguinal ring
- grade I-II edema at pubic symphysis on MRI scan is allowed
Exclusion Criteria:
- patients not willing to participate
- inguinal or femoral hernia
- MRI reveals other major pathology
- former surgery to the actual groin
- allergy to polypropylene or other contra-indication to surgery
Sites / Locations
- Hannu PaajanenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Open repair
Endoscopic TEP repair
Arm Description
Open minimal repair (OMR) of Sportsman's hernia using 2-0 continuous sutures
Totally Endoscopic extraperitoneal repair (TEP)using lightweight mesh
Outcomes
Primary Outcome Measures
pain relief
The primary endpoint is number of patients having relief of pain during sports activity (VAS scores 0-20, range 0-100) at four weeks after surgery.
Secondary Outcome Measures
time to training
Secondary end-points are time to resume low-level training and full-level training/competing, complications, one year follow-up and costs of surgery
Full Information
NCT ID
NCT01876342
First Posted
June 9, 2013
Last Updated
August 11, 2018
Sponsor
Kuopio University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01876342
Brief Title
TEP Versus Open Repair of Sportsman's Hernia
Acronym
sports hernia
Official Title
Total ExtraPeritoneal (TEP) Versus Open Minimal Suture Repair for Treatment of Sportsman's Hernia/Athletic Pubalgia: A Randomized Multi-center Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kuopio University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Sportsman's hernia causes chronic groin pain in physically active adults. Open hernia repair without mesh or laparoscopic technique with mesh have been advocated in the treatment of sportsman's hernia. The aim of this randomized study is to compare the effectiveness of open technique to laparoscopic technique for the treatment of Sportsman´s hernia. The hypothesis is that laparoscopic technique is less painfull than open surgery for repair of sportsman's hernia.
Detailed Description
Sportsman's hernia is defined as a weakness or disruption of the posterior wall of the inguinal canal. Open hernia repair with or without mesh or laparoscopic techniques with mesh have been advocated in the treatment of sportsman's hernia and associated athletic pubalgia. The results of the operative treatment from single centers are reported to be good to excellent in between 70 - 90% of patients with the most promising results reported using an open minimal repair (OMR) technique. There are no randomized trials comparing open versus laparoscopic techniques regarding time for recovery and relief of pain. The aim of this randomized study is to compare the effectiveness of OMR technique in local or spinal anesthesia to endoscopic Total ExtraPeritoneal (TEP) technique in general anesthesia for the treatment of Sportsman´s hernia/athletic pubalgia. The primary endpoint is patient being free from intractable groin pain during sports activity or daily work four weeks after surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Bone Marrow Oedema
Keywords
sports hernia, sportsman's hernia, chronic groin pain, open minimal repair, totally extraperitoneal endoscopic technique
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Open repair
Arm Type
Experimental
Arm Description
Open minimal repair (OMR) of Sportsman's hernia using 2-0 continuous sutures
Arm Title
Endoscopic TEP repair
Arm Type
Active Comparator
Arm Description
Totally Endoscopic extraperitoneal repair (TEP)using lightweight mesh
Intervention Type
Procedure
Intervention Name(s)
open repair
Intervention Description
2-0 sutures
Intervention Type
Procedure
Intervention Name(s)
endoscopic TEP repair
Intervention Description
mesh
Primary Outcome Measure Information:
Title
pain relief
Description
The primary endpoint is number of patients having relief of pain during sports activity (VAS scores 0-20, range 0-100) at four weeks after surgery.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
time to training
Description
Secondary end-points are time to resume low-level training and full-level training/competing, complications, one year follow-up and costs of surgery
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
males/females professional or non-professional athletes
age 18-50 years
unilateral or bilateral groin pain lasting > 6 weeks
physical examination and MRI indicating sportsman's hernia
pain above inguinal ligament in the deep inguinal ring
grade I-II edema at pubic symphysis on MRI scan is allowed
Exclusion Criteria:
patients not willing to participate
inguinal or femoral hernia
MRI reveals other major pathology
former surgery to the actual groin
allergy to polypropylene or other contra-indication to surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hannu EK Paajanen, MD, PhD
Phone
+358-40-5263101
Ext
+358
Email
hannu.paajanen@kuh.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hannu Paajanen, MD, PhD
Organizational Affiliation
Kuopio University Hospital, Kuopio, Finland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hannu Paajanen
City
Kuopio
ZIP/Postal Code
70600
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hannu EK Paajanen, MD, PhD
Phone
+358-40-5263101
Ext
+358
Email
hannu.paajanen@kuh.fi
First Name & Middle Initial & Last Name & Degree
Hannu EK Paajanen, MD, PhD
First Name & Middle Initial & Last Name & Degree
Agneta Montgomery, MD, PhD
First Name & Middle Initial & Last Name & Degree
Imre Ilves, MD
First Name & Middle Initial & Last Name & Degree
Melih Paksoy, MD
First Name & Middle Initial & Last Name & Degree
Thomas Simon, MD
First Name & Middle Initial & Last Name & Degree
Majiec Smietanski, MD
First Name & Middle Initial & Last Name & Degree
Aali Sheen, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
21549403
Citation
Paajanen H, Brinck T, Hermunen H, Airo I. Laparoscopic surgery for chronic groin pain in athletes is more effective than nonoperative treatment: a randomized clinical trial with magnetic resonance imaging of 60 patients with sportsman's hernia (athletic pubalgia). Surgery. 2011 Jul;150(1):99-107. doi: 10.1016/j.surg.2011.02.016. Epub 2011 May 5.
Results Reference
background
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TEP Versus Open Repair of Sportsman's Hernia
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