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

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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Groin Pain
• Intervention / Treatment: Procedure: Pre peritoneal mesh placement; Procedure: Laparoscopy

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Stuart R Walker, MBBS DM; Phone Number: 61 3 62227064; Email: stuart.walker@dhhs.tas.gov.au

Study Locations

• Australia
  • Tasmania
    • Hobart, Tasmania, Australia, 7000
      • Royal Hobart Hospital
      • Contact: Stuart R Walker, MB BS; Phone Number: 61 3 62227064; Email: stuart.walker@dhhs.tas.gov.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Return to normal activities	3 months

Collaborators and Investigators

• Sponsor: Royal Hobart Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: July 7, 2009
• First Submitted That Met QC Criteria: July 7, 2009
• First Posted (Estimate): July 8, 2009

Study Record Updates

• Last Update Posted (Estimate): March 16, 2010
• Last Update Submitted That Met QC Criteria: March 15, 2010
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: Sportsmans groin, Gilmores groin
• Other Study ID Numbers: SRW 001