TEP Versus Open Repair of Sportsman's Hernia

NCT ID: NCT01876342

Last Updated: 2018-08-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2018-12-31

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.

Conditions

Chronic Pain; Bone Marrow Oedema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Open repair

Open minimal repair (OMR) of Sportsman's hernia using 2-0 continuous sutures

Group Type: EXPERIMENTAL

open repair

Intervention Type: PROCEDURE

2-0 sutures

Endoscopic TEP repair

Totally Endoscopic extraperitoneal repair (TEP)using lightweight mesh

Group Type: ACTIVE_COMPARATOR

endoscopic TEP repair

Intervention Type: PROCEDURE

mesh

Interventions

open repair

2-0 sutures

Intervention Type: PROCEDURE

endoscopic TEP repair

mesh

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kuopio University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hannu Paajanen

Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hannu Paajanen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Kuopio University Hospital, Kuopio, Finland

Locations

Hannu Paajanen

Kuopio, , Finland

Site Status: RECRUITING

Countries

Finland

Central Contacts

Hannu EK Paajanen, MD, PhD

Role: CONTACT

hannu.paajanen@kuh.fi

+358-40-5263101 ext. +358

Facility Contacts

Hannu EK Paajanen, MD, PhD

Role: primary

hannu.paajanen@kuh.fi

+358-40-5263101 ext. +358

References

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.

Reference Type: BACKGROUND

PMID: 21549403 (View on PubMed)

Other Identifiers

27/2013

Identifier Type: REGISTRY

Identifier Source: secondary_id

27/2013

Identifier Type: -

Identifier Source: org_study_id