TEP Versus Open Minimal Suture Repair for the Sportsman's Groin
Condition: Hernia
MeSH terms: Hernia
Study type: Interventional

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.
    

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.
    

Intervention name(s): Total ExtraPeritoneal; Open minimal suture repair
Intervention type(s): Procedure; Procedure
Intervention description(s): 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.; 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.
Other intervention name(s): Open technique (OMR)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment