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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00934388




Registration number
NCT00934388
Ethics application status
Date submitted
7/07/2009
Date registered
8/07/2009
Date last updated
16/03/2010

Titles & IDs
Public title
A Randomised, Blinded Study on Laparoscopic Mesh Reinforcement for Chronic Groin Pain
Scientific title
A Randomised, Blinded Study on Laparoscopic Mesh Reinforcement for Chronic Groin Pain.
Secondary ID [1] 0 0
SRW 001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Groin Pain 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Pre peritoneal mesh placement
Treatment: Surgery - Laparoscopy

Experimental: Mesh placed in pre peritoneal plane -

Active Comparator: No mesh placed -


Treatment: Surgery: Pre peritoneal mesh placement


Treatment: Surgery: Laparoscopy
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Return to normal activities
Timepoint [1] 0 0
3 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2015
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 0 0
Royal Hobart Hospital - Hobart
Recruitment postcode(s) [1] 0 0
7000 - Hobart

Funding & Sponsors
Primary sponsor type
Other
Name
Royal Hobart Hospital
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00934388
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Stuart R Walker, MBBS DM
Address 0 0
Country 0 0
Phone 0 0
61 3 62227064
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00934388