Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000713695
Ethics application status
Approved
Date submitted
28/10/2005
Date registered
4/11/2005
Date last updated
4/11/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pilot Study of effect of topical anaesthetic on cervical compliance.
Scientific title
A pilot study to evaluate the effects of topical anaesthetic fluid, injected into the cervical canal, to relax the fibro-elastic tissues of the cervix to increase patient comfort and safety for outpatient hysteroscopy.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervical softening/compliance 863 0
Condition category
Condition code
Anaesthesiology 930 930 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Following the introduction of anaesthetic ***INTO THE UTERINE CAVITY*** the patient will be cleaned and draped for their procedure in routine fashion whilst the surgeons scrub. The agent must be left within the endometrial cavity for 6 minutes prior to testing cervical compliance. After 6 minutes a disposable intra-uterine catheter (usually used for performing hystero-salpingograms) will be passed into the endometrial cavity. A small balloon at the end of the device will be inflated with ***1.0*** ml saline and the balloon withdrawn till some resistance is felt as the balloon reaches the internal cervical os. At this point a force gauge (supplied by department of biomedical engineering, sensitive to within 10 grams) is attached to the end of the catheter. The inflated balloon is then withdrawn through the cervix and the maximum force required to pass the balloon through the internal cervical os is recorded
Intervention code [1] 739 0
None
Comparator / control treatment
A placebo will be introduced instead of an anaesthetic.
Control group
Active

Outcomes
Primary outcome [1] 1218 0
To assess cervical compliance/softening after the application of topical local anaesthetic
Timepoint [1] 1218 0
After the application of topical local anaesthetic
Secondary outcome [1] 2214 0
N/A
Timepoint [1] 2214 0

Eligibility
Key inclusion criteria
Having elective laparoscopic or hysteroscopic surgeryIntact uterus.
Minimum age
18 Years
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Currently menstruatingSuspected diagnosis of gynaecological malignancies or precursorsPossibility of current pregnancy.

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)
The patient will be informed that she will be allocated to one of two arms, active or placebo. There will be no concealment to staff performing the procedure as to which arm the patient has been allocated to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
There is no sequence generation as the patients will be randomised to alternate arms only.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/01/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1027 0
Self funded/Unfunded
Name [1] 1027 0
Country [1] 1027 0
Primary sponsor type
Individual
Name
Associate Professor Thierry Vancaillie
Address
Country
Secondary sponsor category [1] 891 0
None
Name [1] 891 0
N/A
Address [1] 891 0
Country [1] 891 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2329 0
South East Area and Ilawarra Health Service
Ethics committee address [1] 2329 0
Ethics committee country [1] 2329 0
Australia
Date submitted for ethics approval [1] 2329 0
Approval date [1] 2329 0
Ethics approval number [1] 2329 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36131 0
Address 36131 0
Country 36131 0
Phone 36131 0
Fax 36131 0
Email 36131 0
Contact person for public queries
Name 9928 0
Dr. Stephen Lyons
Address 9928 0
Department of Endo-Gynaecology
Level 2
Barker Street
Randwick NSW 2031
Country 9928 0
Australia
Phone 9928 0
+61 2 93826557
Fax 9928 0
+61 2 93826244
Email 9928 0
Lyonss@sesahs.nsw.gov.au
Contact person for scientific queries
Name 856 0
Associate Professor Thierry Vancaillie
Address 856 0
Department of Endo-Gynaecology
Level 2
Barker Street
Randwick NSW 2031
Country 856 0
Australia
Phone 856 0
+61 2 93826557
Fax 856 0
+61 2 93826244
Email 856 0
t.vancaillie@unsw.edu.au

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.