TEP Versus Open Repair of Sportsman's Hernia

Not Applicable

• Conditions: Chronic Pain; Bone Marrow Oedema

• Registration Number: NCT01876342
• Lead Sponsor: Kuopio University Hospital

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.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-09
• Study First Submitted QC: 2013-06-09
• Study First Posted: 2013-06-12
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-11
• Last Update Posted: 2018-08-14
• Primary Completion: 2018-11
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
pain relief	4 weeks	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

Name	Time	Method
time to training	3 months	Secondary end-points are time to resume low-level training and full-level training/competing, complications, one year follow-up and costs of surgery

Trial Locations

Locations (1)

Hannu Paajanen; 🇫🇮 Kuopio, Finland