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.
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
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 group | Role | What they receive |
|---|---|---|
| Total ExtraPeritoneal | Experimental | Total ExtraPeritoneal (TEP) technique in general anesthesiacanal from behind Receives: Procedure: Total ExtraPeritoneal |
| Open minimal suture repair | Active comparator | Open 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.
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)
Secondary end-points are time to resume low-level training and full-level training/competing.
Measured: 1 year
One year follow-up of post-surgery complications
Measured: 1 year
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.
- First posted21 Nov 2014 (estimated)
- Study start3 Dec 2014
- Primary completion14 Sep 2017
- Study completion14 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Aali Sheen, Principal investigator, Manchester University NHS Foundation Trust
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total ExtraPeritoneal (TEP) Versus Open Minimal Suture Repair for Treatment of Sportsman's Hernia/Athletic Pubalgia: A Randomized Multi-center Trial.
- ClinicalTrials.gov ID
- NCT02297711
- Acronym / sponsor ID
- SPORT / R03430
- Conditions
- Hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Study start
- 3 Dec 2014 (actual)
- Primary completion
- 14 Sep 2017 (actual)
- Study completion
- 14 Sep 2017 (actual)
- First posted
- 21 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total ExtraPeritoneal | Experimental | Procedure: Total ExtraPeritonealTotal ExtraPeritoneal (TEP) technique in general anesthesiacanal from behind |
| Open minimal suture repair | Active comparator | Procedure: Open minimal suture repairOpen minimal repair (OMR) technique in local or spinal anesthesia |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total ExtraPeritonealThis 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. | Procedure or surgery | Total ExtraPeritoneal |
| Open minimal suture repairAlso: 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. | Procedure or surgery | Open minimal suture repair |
Primary outcome
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
3 secondary outcomes
Secondary end-points are time to resume low-level training and full-level training/competing.
Time frame: 1 year
One year follow-up of post-surgery complications
Time frame: 1 year
Costs of surgery
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Derived from this study: PubMed 31162653Sheen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aali Sheen principal investigator
Manchester University NHS Foundation Trust
1 site in 1 country: see every site and its status.
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; AzTrials last refreshed its copy on 8 Nov 2026.