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/ct2/show/NCT00484835




Registration number
NCT00484835
Ethics application status
Date submitted
8/06/2007
Date registered
11/06/2007
Date last updated
8/08/2007

Titles & IDs
Public title
Are Sutures Required in Total Abdominal Hysterectomy? A Randomised Control Trial
Scientific title
Randomised Control Trial Comparing Hysterectomy Using Electrocoagulation Forceps With the Traditional Clamp & Suture Technique of Richardson Abdominal Hysterectomy
Secondary ID [1] 0 0
Electrocoag Forceps in TAH
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Performing abdominal hysterectomy using gyrus electrocoagulation forceps

Treatment: Surgery: Performing abdominal hysterectomy using gyrus electrocoagulation forceps
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Operating time, Blood loss, Post-operative pain
Timepoint [1] 0 0
1 year
Secondary outcome [1] 0 0
Length of hospital stay, Cost of the procedure
Timepoint [1] 0 0
1 year

Eligibility
Key inclusion criteria
- Any patient already on waitlist in Southern Health for abdominal hysterectomy with
suspected benign pathology
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Patients without consent and/or with suspected malignant pathology

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
1/09/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2008
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Casey Hospital - Melbourne
Recruitment hospital [2] 0 0
Dandenong Hospital - Melbourne
Recruitment hospital [3] 0 0
Monash Medical Centre(Moorabin) - Melbourne
Recruitment postcode(s) [1] 0 0
- 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
Gyrus ACMI
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The Hypothesis of this study is that performing total abdominal hysterectomy using the newer
electrocoagulation forceps, specifically, the gyrus open seal forceps, curved, compared to
the traditional clamp & suture technique will result in reduction of operating time,
intra-operative blood loss, post-operative pain.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00484835
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Marziya Kadir, MBBS
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
Marziya Kadir, MBBS
Address 0 0
Country 0 0
Phone 0 0
613 95946666
Fax 0 0
Email 0 0
marziya@hotmail.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00484835