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

• Sponsor: Royal Hobart Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00934388
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Duration (Months): 59
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• Anticipated 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: Jan 1, 2011
• Anticipated Primary Completion Date: Dec 1, 2015
• Anticipated Study Completion Date: Dec 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Return to normal activities [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Royal Hobart Hospital	Hobart	Tasmania	Australia	7000

Sponsors and Collaborators

• Royal Hobart Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00934388
• Other Study ID Numbers: SRW 001
• First Posted: Jul 8, 2009
• Last Update Posted: Mar 16, 2010
• Last Verified: Mar 1, 2010

• Keywords provided by , ,: Sportsmans groin, Gilmores groin

Study Results

No Results Posted as of Mar 16, 2010