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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/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
Treatment: Surgery - Performing Vaginal hysterectomy with Harmonic Scalpel

Treatment: Surgery: Performing Vaginal hysterectomy with Harmonic Scalpel
Intervention code [1] 0 0
Treatment: Surgery
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 status
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
The hypotheses of this study is that the use of the instrument "Harmonic Scalpel" (ultrasonic
shears) for vaginal hysterectomy instead of traditional sutures confers advantage over the
use of traditional clamps and sutures. The proposed benefits and outcome measures are reduced
blood loss, reduced operating time, reduced post-operative pain and earlier discharge from
hospital. Other outcome measure will include complications and cost.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00456170
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00456170