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A Randomised, Blinded Study on Laparoscopic Mesh Reinforcement for Chronic Groin Pain

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ClinicalTrials.gov Identifier: NCT00934388
Recruitment Status : Unknown
Verified March 2010 by Royal Hobart Hospital.
Recruitment status was:  Not yet recruiting
First Posted : July 8, 2009
Last Update Posted : March 16, 2010
Sponsor:
Information provided by:
Royal Hobart Hospital

Brief Summary:

Chronic groin pain is a frequent cause for referral to general surgeons. In some cases this pain may be due to the presence of a hernia. However, if on clinical examination there is no palpable lump or bulge, the cause of the pain may be difficult to elucidate. Some of these patients may have the diagnosis of sportsman's groin. Other names which have been attached to this condition include Gilmores groin and sportsmans hernia. These conditions are more commonly associated with sportsmen and women but those who do not play sport may also receive this diagnosis. Sportsman's groin is thought to be a syndrome of weakness of the posterior inguinal wall without a clinically recognisable hernia. Differing explanations for sportsman's groin include avulsion of the conjoint tendon from the pubic tubercle, weakening of the transversalis fascia, tears in the internal or external oblique, superficial inguinal ring dilatation and abnormalities of the rectus abdominus insertion.

There is some evidence that pre peritoneal mesh placement in these patients may be beneficial. The theory being that the mesh prevents pressure transmission to the damages structures, allowing them to heal more rapidly.

Aim. To assess the potential benefit of pre peritoneal mesh placement using the TAPP technique in patients with chronic groin pain.


Condition or disease Intervention/treatment Phase
Chronic Groin Pain Procedure: Pre peritoneal mesh placement Procedure: Laparoscopy Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Blinded Study on Laparoscopic Mesh Reinforcement for Chronic Groin Pain.
Study Start Date : January 2011
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Arm Intervention/treatment
Experimental: Mesh placed in pre peritoneal plane Procedure: Pre peritoneal mesh placement
Active Comparator: No mesh placed Procedure: Laparoscopy



Primary Outcome Measures :
  1. Return to normal activities [ Time Frame: 3 months ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Groin pain (unilateral or bilateral) for at least 4 months. In this way, patients with temporary symptoms will be excluded from undergoing unnecessary surgery.
  • Tenderness over pubic tubercle or superficial inguinal ring.

Exclusion Criteria:

  • Aged less than 18 years Aged more than 50 years - due to increased incidence of sacro-iliac and hip pathology.
  • Bulge, lump or cough impulse consistent with inguinal or femoral hernia on clinical examination.
  • Patients unwilling or unable to provide informed consent. Medically unfit for general anaesthetic
  • Pregnant women
  • Diabetes - due to diabetic neuropathy
  • Steroid use
  • QST suggestive of nerve entrapment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00934388


Contacts
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Contact: Stuart R Walker, MBBS DM 61 3 62227064 stuart.walker@dhhs.tas.gov.au

Locations
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Australia, Tasmania
Royal Hobart Hospital
Hobart, Tasmania, Australia, 7000
Contact: Stuart R Walker, MB BS    61 3 62227064    stuart.walker@dhhs.tas.gov.au   
Principal Investigator: Stuart R Walker, MBBS         
Sponsors and Collaborators
Royal Hobart Hospital
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Responsible Party: Mr. Stuart Walker, Royal Hobart Hospital
ClinicalTrials.gov Identifier: NCT00934388    
Other Study ID Numbers: SRW 001
First Posted: July 8, 2009    Key Record Dates
Last Update Posted: March 16, 2010
Last Verified: March 2010
Keywords provided by Royal Hobart Hospital:
Sportsmans groin, Gilmores groin