Clinical trial NCT01876342: TEP Versus Open Repair of Sportsman's 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
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain
Bone Marrow Oedema
Keywords: sports hernia
sportsman's hernia
chronic groin pain
open minimal repair
totally extraperitoneal endoscopic technique
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
First posted: 2013-06-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: pain relief
timeFrame: 4 weeks
Secondary outcomes:
measure: time to training
timeFrame: 3 months
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Hannu Paajanen
Study officials:
affiliation: Kuopio University Hospital, Kuopio, Finland
name: Hannu Paajanen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.