Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00456170




Registration number
NCT00456170
Ethics application status
Date submitted
3/04/2007
Date registered
4/04/2007
Date last updated
4/04/2007

Titles & IDs
Public title
Are Sutures Required for Vaginal Hysterectomy: A Randomized Controlled Trial
Scientific title
Randomized Controlled Trial Comparing Traditional Vaginal Hysterectomy to Harmonic Scalpel Hysterectomy
Secondary ID [1] 0 0
Harmonic Vag Hyst
Universal Trial Number (UTN)
Trial acronym
HAVE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vaginal Hysterectomy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pain score
Timepoint [1] 0 0
Primary outcome [2] 0 0
Time to discharge
Timepoint [2] 0 0
Primary outcome [3] 0 0
Blood loss
Timepoint [3] 0 0
Secondary outcome [1] 0 0
Cost
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Complications
Timepoint [2] 0 0

Eligibility
Key inclusion criteria
* Any patient already on waitlist requiring vaginal hysterectomy
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* No patient consent

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
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
1/04/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Moorabin Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
8148 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Southern Health
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Johnson & Johnson
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Jason J Tan, MBBS MRANZCOG
Address 0 0
Southern Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jason J Tan, MBBS, MRANZCG
Address 0 0
Country 0 0
Phone 0 0
+61409116446
Fax 0 0
Email 0 0
[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/NCT00456170