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

K

Kuopio University Hospital

Status

Unknown

Conditions

Bone Marrow Oedema
Chronic Pain

Treatments

Procedure: open repair
Procedure: endoscopic TEP repair

Study type

Interventional

Funder types

Other

Identifiers

NCT01876342
27/2013 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

Open repair
Experimental group
Description:
Open minimal repair (OMR) of Sportsman's hernia using 2-0 continuous sutures
Treatment:
Procedure: open repair
Endoscopic TEP repair
Active Comparator group
Description:
Totally Endoscopic extraperitoneal repair (TEP)using lightweight mesh
Treatment:
Procedure: endoscopic TEP repair

Trial contacts and locations

1

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Central trial contact

Hannu EK Paajanen, MD, PhD

Data sourced from clinicaltrials.gov

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