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

NCT00934388 | Unknown Phase 3

• 1 other identifier: SRW 001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

Sportsmans groin, Gilmores groin

Outcome Measures

Primary Outcomes (1)

• Return to normal activities

  3 months

Study Arms (2)

Mesh placed in pre peritoneal plane

EXPERIMENTAL

Procedure: Pre peritoneal mesh placement

No mesh placed

ACTIVE COMPARATOR

Procedure: Laparoscopy

Interventions

Pre peritoneal mesh placement PROCEDURE

Mesh placed in pre peritoneal plane

Laparoscopy PROCEDURE

No mesh placed

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Royal Hobart Hospital: lead

Study Sites (1)

Royal Hobart Hospital

Hobart, Tasmania, 7000, Australia

Location

MeSH Terms

Interventions

Laparoscopy

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Stuart R Walker, MBBS DM

CONTACT

61 3 62227064; stuart.walker@dhhs.tas.gov.au

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: July 7, 2009
• First Posted: July 8, 2009
• Study Start: January 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 16, 2010

Record last verified: 2010-03

Locations

AU (1)