TEP Versus Open Repair of Sportsman's Hernia
sports hernia
Total ExtraPeritoneal (TEP) Versus Open Minimal Suture Repair for Treatment of Sportsman's Hernia/Athletic Pubalgia: A Randomized Multi-center Trial
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable chronic-pain
Started Jun 2013
Longer than P75 for not_applicable chronic-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 9, 2013
CompletedFirst Posted
Study publicly available on registry
June 12, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedAugust 14, 2018
August 1, 2018
5.4 years
June 9, 2013
August 11, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
4 weeks
Secondary Outcomes (1)
time to training
3 months
Study Arms (2)
Open repair
EXPERIMENTALOpen minimal repair (OMR) of Sportsman's hernia using 2-0 continuous sutures
Endoscopic TEP repair
ACTIVE COMPARATORTotally Endoscopic extraperitoneal repair (TEP)using lightweight mesh
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hannu Paajanen
Kuopio, 70600, Finland
Related Publications (1)
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.
PMID: 21549403BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hannu Paajanen, MD, PhD
Kuopio University Hospital, Kuopio, Finland
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Surgery
Study Record Dates
First Submitted
June 9, 2013
First Posted
June 12, 2013
Study Start
June 1, 2013
Primary Completion
November 1, 2018
Study Completion
December 1, 2018
Last Updated
August 14, 2018
Record last verified: 2018-08