TEP Versus Open Minimal Suture Repair for the Sportsman's Groin

NCT02297711 | Completed DMC

• 1 other identifier: R03430
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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

Hernia

Outcome Measures

Primary Outcomes (1)

• 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 (3)

• Secondary end-points are time to resume low-level training and full-level training/competing.

  1 year

• One year follow-up of post-surgery complications

  1 year

• Costs of surgery

  1 year

Study Arms (2)

Total ExtraPeritoneal

EXPERIMENTAL

Total ExtraPeritoneal (TEP) technique in general anesthesiacanal from behind

Procedure: Total ExtraPeritoneal

Open minimal suture repair

ACTIVE COMPARATOR

Open minimal repair (OMR) technique in local or spinal anesthesia

Procedure: Open minimal suture repair

Interventions

Total ExtraPeritoneal PROCEDURE

This is a keyhole operation which will use one small incision at the 'belly button' followed by two small incisions of approximately 5mm in diameter below the 'belly button' . A lightweight mesh is then placed over the inguinal ligament to reinforce the weakness. This approach is keyhole in nature with visualisation of the inguinal canal from behind - posteriorly.

Total ExtraPeritoneal

Open minimal suture repair PROCEDURE

This is best described as open minimal repair and involves a small incision into the groin of the affected side. Once the inguinal canal is exposed the back wall is repaired using a simple suture to reinforce the weakness. This approach is open surgery in nature with visualisation of the inguinal canal from in front - anteriorly.

Also known as: Open technique (OMR)

Open minimal suture repair

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• both males and females either professional or non-professional athletes or physically active adults
• age 18-50 years
• unilateral or bilateral complains (in bilateral pain both sides are to be operated and the randomization is on patient level and not hernia level)
• chronic dull, diffuse groin pain lasting \> 6weeks
• history, physical examination and MRI indicating sportsman's hernia/athletic pubalgia
• pain above inguinal ligament in the deep inguinal ring, may radiate inner thigh, scrotum or pubic bone
• minor radiating pain can be at adductor origin or symphysis pubis
• grade I-II edema at pubic symphysis on MRI scan is allowed (can be secondary after groin disruption)

You may not qualify if:

• patients not willing to participate
• inguinal or femoral hernia
• MRI reveals other major pathology (bursitis, hip injury, stress fracture etc)
• isolated adductor tendonitis with groin pain below inguinal ligament
• femoro-acetabular impingement (FAI)
• isolated severe osteitis pubis (marked x-ray changes; grade III edema in MRI)
• former surgery to the actual groin
• allergy to polypropylene or other contra-indication to surgery

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead

Study Sites (1)

Central Manchester University Hospitals NHS Foundation Trust

Manchester, Manchester (Manchester Borough), M13 9WL, United Kingdom

Location

Related Publications (1)

• Sheen AJ, Montgomery A, Simon T, Ilves I, Paajanen H. Randomized clinical trial of open suture repair versus totally extraperitoneal repair for treatment of sportsman's hernia. Br J Surg. 2019 Jun;106(7):837-844. doi: 10.1002/bjs.11226.

  PMID: 31162653 DERIVED

MeSH Terms

Conditions

Hernia

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Aali Sheen

  Manchester University NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2014
• First Posted: November 21, 2014
• Study Start: December 3, 2014
• Primary Completion: September 14, 2017
• Study Completion: September 14, 2017
• Last Updated: March 18, 2020

Record last verified: 2020-03

Locations

GB (1)