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

Chronic Groin Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00934388
• Other study ID #: SRW 001
• Status: Not yet recruiting
• Phase: Phase 3
• First received: July 7, 2009
• Last updated: March 15, 2010
• Start date: January 2011
• Est. completion date: December 2015

Study information

• Verified date: March 2010
• Source: Royal Hobart Hospital
• Contact: Stuart R Walker, MBBS DM
• Phone: 61 3 62227064
• Email: stuart.walker[@]dhhs.tas.gov.au
• Is FDA regulated: No
• Health authority: Australia: Human Research and Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Groin Pain

Intervention

Procedure:
• Pre peritoneal mesh placement

• Laparoscopy

Locations

Country	Name	City	State
Australia	Royal Hobart Hospital	Hobart	Tasmania

Sponsors (1)

Lead Sponsor	Collaborator
Royal Hobart Hospital

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Return to normal activities		3 months	Yes