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

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00934388
Enrollment
80
Registered
2009-07-08
Start date
2011-01-31
Completion date
2015-12-31
Last updated
2010-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Groin Pain

Keywords

Sportsmans groin, Gilmores groin

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.

Interventions

PROCEDUREPre peritoneal mesh placement
PROCEDURELaparoscopy

Sponsors

Royal Hobart Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
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.

Design outcomes

Primary

MeasureTime frame
Return to normal activities3 months

Countries

Australia

Contacts

Primary ContactStuart R Walker, MBBS DM
stuart.walker@dhhs.tas.gov.au61 3 62227064

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026