TEP Versus Open Repair of Sportsman's Hernia

Chronic Pain Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01876342
• Other study ID #: 27/2013
• Secondary ID: 27/2013
• Status: Recruiting
• Phase: N/A
• Start date: June 2013
• Est. completion date: December 2018

Study information

• Verified date: August 2018
• Source: Kuopio University Hospital
• Contact: Hannu EK Paajanen, MD, PhD
• Phone: +358-40-5263101
• Email: hannu.paajanen[@]kuh.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Marrow Oedema
• Chronic Pain
• Hernia

Intervention

Procedure:
• open repair
2-0 sutures
• endoscopic TEP repair
mesh

Locations

Country	Name	City	State
Finland	Hannu Paajanen	Kuopio

Sponsors (1)

Lead Sponsor	Collaborator
Kuopio University Hospital

Country where clinical trial is conducted

Finland, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	3 months