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HerniaSPORTNCT02297711

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

A study testing Total ExtraPeritoneal and Open minimal suture repair in people with Hernia, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Hernia
What is being tested?
Total ExtraPeritoneal and Open minimal suture repair
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
1 siteUnited Kingdom
Study dates
3 Dec 2014to 14 Sep 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Central Manchester University Hospitals NHS Foundation Trust

    Manchester, Manchester (Manchester Borough), M13 9WL

Other trials in United Kingdom

About this study

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

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.

Read the detailed description

The prevalence of chronic groin pain in athletes and physically active adults is between 5 and 10 % (1-3). The groin area is vulnerable in contact sports such as soccer, ice hockey, and rugby that require sudden muscle contraction around the hip and lower abdomen, repetitive kicking and side-to-side motion. Common causes for chronic groin pain in such sports include adductor tendonitis, musculus rectus abdominis tendopathy, osteitis pubis (edema on MRI scans at pubic symphysis) or disruption of the posterior wall of inguinal canal, which are all referred to as athletic pubalgia (1-3). No exact pathophysiological mechanism for pain has so far been identified in sportsman's hernia (posterior inguinal wall deficiency). A tear of the abdominal wall in posterior inguinal canal or conjoined tendon (tendinopathy), with or without bulging of a hernia, is suggested to be typical for a sportsman's hernia (4-6). The tissue damage is similar as in an incipient direct inguinal hernia with or without bulge. Diagnosis of a sportsman's hernia can only be set in patients having a typical history and having a suspected posterior inguinal wall deficiency on careful clinical examination. Magnetic resonance imaging (MRI) should be performed to exclude other injuries in the groin area. Sometimes also ultrasonography (US) would be added in the diagnostic work-up. Although presenting with similarly symptoms, the clinical entity of ''sportsman's hernia'' is exclusively distinct from athletic pubalgia (7), which includes a more wide range of groin injuries, such as adductor tendonitis and/or inflammation of the pubic symphysis (8,9).

Treatment of chronic groin pain is aimed toward its specific pathology (1-3). The first line of management includes rest, muscle strengthening and stretching exercises, physiotherapy, anti-inflammatory analgesics, as well as local anesthetic and/or corticosteroid injections. In resistant cases, operative treatment might be considered. Various operative approaches in athlete's pubalgia have been proposed depending on the suspected nature of injury. These operative approaches include open (5,10) and laparoscopic methods of hernia repair (11-12), tenotomies of muscle tendons close to the pubic bone (13,14), as well as release or neurectomies of nearby nerves (6-7). The results of operative treatment are good to excellent in 70 to 90% of patients (1-3). There is no evidence-based consensus available to guide surgeons for choosing between various operative treatments of sportsman's hernia/athletic pubalgia (1). Both conventional open and laparoscopic repairs produce good results, although the latter may allow the patient to an earlier return to full sports activity.

Open minimal repair (OMR) technique in local or spinal anesthesia seems to be a promising surgical approach in the treatment of posterior inguinal wall deficiency (10). Recent one-center analysis of this technique reported full freedom of pain in 91% four weeks after operation, full recovery to sports after 2 weeks and good patient's satisfaction in 100%. The laparoscopic techniques are reported to give an excellent outcome in 80-90% of patients. These methods are more expensive and need to be performed under general anesthesia. The studies are also heterogeneous concerning the use of different types of mesh and fixation techniques (11-12). Comparative studies between the OMR technique and laparoscopic treatment of sportsman's hernia/athletic pubalgia are lacking. The OMR technique is developed solely to strengthen the posterior inguinal wall weakness using non-absorbable sutures, but theoretically the TEP technique may heal a wider area in groin utilizing a 10x15 cm mesh placed in the preperitoneal space behind the pubic symphysis and posterior inguinal canal (11).

The aim of this randomized study is to compare the effectiveness of OMR technique in local or spinal anesthesia to TEP technique in general anesthesia for treatment of Sportsman´s hernia/athletic pubalgia with the primary endpoint; patients being totally free from groin pain during sports activity four weeks after surgery.

Conditions
Hernia
Being tested
Total ExtraPeritoneal, Open minimal suture repair
Medical subject headings
Hernia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Total ExtraPeritonealProcedure or surgery

    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.

  • Open minimal suture repairProcedure or surgery

    Also called Open technique (OMR)

    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.

Study groups in NCT02297711
Study groupRoleWhat they receive
Total ExtraPeritonealExperimentalTotal ExtraPeritoneal (TEP) technique in general anesthesiacanal from behind
Receives: Procedure: Total ExtraPeritoneal
Open minimal suture repairActive comparatorOpen minimal repair (OMR) technique in local or spinal anesthesia
Receives: Procedure: Open minimal suture repair

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 4 weeks

Secondary outcomes (3)
  1. Secondary end-points are time to resume low-level training and full-level training/competing.

    Measured: 1 year

  2. One year follow-up of post-surgery complications

    Measured: 1 year

  3. Costs of surgery

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2014 (estimated)
  2. Study start3 Dec 2014
  3. Primary completion14 Sep 2017
  4. Study completion14 Sep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02297711
Sponsor's protocol ID
R03430
Acronym
SPORT
Status last verified
Mar 2020
First submitted
25 Sep 2014
Last updated
18 Mar 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 31162653

Questions about this trial

What is this clinical trial studying?

A study testing Total ExtraPeritoneal and Open minimal suture repair in people with Hernia, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02297711, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2020.

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