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

NCT ID: NCT00934388

Last Updated: 2010-03-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2015-12-31

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.

Conditions

Chronic Groin Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Mesh placed in pre peritoneal plane

Group Type: EXPERIMENTAL

Pre peritoneal mesh placement

Intervention Type: PROCEDURE

No mesh placed

Group Type: ACTIVE_COMPARATOR

Laparoscopy

Intervention Type: PROCEDURE

Interventions

Pre peritoneal mesh placement

Intervention Type: PROCEDURE

Laparoscopy

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Royal Hobart Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Royal Hobart Hospital

Locations

Royal Hobart Hospital

Hobart, Tasmania, Australia

Countries

Australia

Central Contacts

Stuart R Walker, MBBS DM

Role: CONTACT

stuart.walker@dhhs.tas.gov.au

61 3 62227064

Facility Contacts

Stuart R Walker, MB BS

Role: primary

stuart.walker@dhhs.tas.gov.au

61 3 62227064

Other Identifiers

SRW 001

Identifier Type: -

Identifier Source: org_study_id