ANZCTR - Registration

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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]

SRW 001

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Chronic Groin Pain

Condition category

Condition code

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Experimental: Mesh placed in pre peritoneal plane -

Active comparator: No mesh placed -

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Return to normal activities

Timepoint [1]

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?

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

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

TAS

Recruitment hospital [1]

Royal Hobart Hospital - Hobart

Recruitment postcode(s) [1]

7000 - Hobart

Funding & Sponsors

Primary sponsor type

Government body

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/study/NCT00934388

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Stuart R Walker, MBBS DM

Address

Country

Phone

61 3 62227064

Fax

[email protected]

Contact person for scientific queries

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00934388

Trial Review

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