TEP Versus Open Repair of Sportsman's Hernia (sports hernia)

August 11, 2018 updated by: Hannu Paajanen, Kuopio University Hospital

Total ExtraPeritoneal (TEP) Versus Open Minimal Suture Repair for Treatment of Sportsman's Hernia/Athletic Pubalgia: A Randomized Multi-center Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Finland
      • Kuopio, Finland, 70600
        • Recruiting
        • Hannu Paajanen
        • Contact:
        • Sub-Investigator:
          • Agneta Montgomery, MD, PhD
        • Sub-Investigator:
          • Imre Ilves, MD
        • Sub-Investigator:
          • Melih Paksoy, MD
        • Sub-Investigator:
          • Thomas Simon, MD
        • Sub-Investigator:
          • Majiec Smietanski, MD
        • Sub-Investigator:
          • Aali Sheen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Open repair
Open minimal repair (OMR) of Sportsman's hernia using 2-0 continuous sutures
Procedure: open repair
2-0 sutures
ACTIVE_COMPARATOR: Endoscopic TEP repair
Totally Endoscopic extraperitoneal repair (TEP)using lightweight mesh
Procedure: endoscopic TEP repair
mesh

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain relief
Time Frame: 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.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time to training
Time Frame: 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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kuopio University Hospital

Investigators

  • Principal Investigator: Hannu Paajanen, MD, PhD, Kuopio University Hospital, Kuopio, Finland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (ANTICIPATED)

November 1, 2018

Study Completion (ANTICIPATED)

December 1, 2018

Study Registration Dates

First Submitted

June 9, 2013

First Submitted That Met QC Criteria

June 9, 2013

First Posted (ESTIMATE)

June 12, 2013

Study Record Updates

Last Update Posted (ACTUAL)

August 14, 2018

Last Update Submitted That Met QC Criteria

August 11, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27/2013 (REGISTRY: 27/2013)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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