Trial Review

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 registered on ANZCTR


Registration number
ACTRN12619000090112
Ethics application status
Approved
Date submitted
16/01/2019
Date registered
22/01/2019
Date last updated
8/01/2020
Date data sharing statement initially provided
22/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of two commonly used devices during surgical removal of the uterus in women
Scientific title
Rumi II v Biswas colpotomiser at laparoscopic hysterectomy: a randomised clinical trial to compare operative time, perioperative outcomes and surgeon preference
Secondary ID [1] 297140 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Benign gynaecological disorders 311092 0
Condition category
Condition code
Reproductive Health and Childbirth 309724 309724 0 0
Menstruation and menopause
Surgery 309725 309725 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Laparoscopic hysterectomy requires the use of a colpotomiser device. This allows the uterus to be manipulated to provide adequate surgical access, gaining separation from adjacent structures (such as the bladder and ureters) which are to be protected and conserved. There are many different types of colpotomiser device. One such device is the Biswas uterovaginal elevator (Karl Storz, Germany)- reusable rigid rod which screws into the uterocervical canal and over which a silicone cone delineates the vaginal fornices. Another commonly used device is the Rumi II (Cooper Surgical, USA). The reusable handle is combined with disposable elements of varying size, including the articulating tips and the Koh-Efficient colpotomy cup with pneumo-occlusion balloon. There is minimal evidence to guide surgeons as to whether any particular colpotomiser performs better than another. The intervention in this trial does not change usual surgical care including insertion of one of these devices by the surgeon at the beginning of the procedure. The device is removed from the patient upon complete surgical separation of the uterus.
Intervention code [1] 313360 0
Treatment: Devices
Comparator / control treatment
Biswas is the comparator device
Control group
Active

Outcomes
Primary outcome [1] 318692 0
Operating time. The following times will be recorded by the scout nurse for each of the following steps: start of operation, insertion of colpotomiser, completion of colpotomy, completion of surgery
Timepoint [1] 318692 0
At the time of surgery
Secondary outcome [1] 365740 0
Estimated blood loss- measuring cylinder attached to suction apparatus
Timepoint [1] 365740 0
At the time of surgery
Secondary outcome [2] 365741 0
Peri-operative complications (blood transfusion, urinary tract injury, uterine perforation, readmission, return to theatre). These are reported by the surgeon on a study-specific data collection form.
Timepoint [2] 365741 0
Within 28 days of surgery
Secondary outcome [3] 365742 0
Conversion to alternative colpotomiser device, as reported by the primary surgeon on a study-specific data collection form.
Timepoint [3] 365742 0
At the time of surgery
Secondary outcome [4] 365743 0
Ease of colpotomiser insertion (recorded on the Surgeon satisfaction Likert scale questionnaire)
Timepoint [4] 365743 0
Upon completion of surgery.
Secondary outcome [5] 366008 0
Ease of colpotomy (recorded on the Surgeon satisfaction Likert scale questionnaire)
Timepoint [5] 366008 0
Upon completion of surgery
Secondary outcome [6] 366009 0
Quality of uterine manipulation and surgical access (recorded on the Surgeon satisfaction Likert scale questionnaire)
Timepoint [6] 366009 0
Upon completion of surgery
Secondary outcome [7] 366010 0
Maintenance of pneumoperitoneum (recorded on the Surgeon satisfaction Likert scale questionnaire)
Timepoint [7] 366010 0
Upon completion of surgery

Eligibility
Key inclusion criteria
Women over the age of 18 years who are undergoing laparoscopic hysterectomy for any benign gynaecological indication
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy.
Known or suspected malignancy.
Uterine size exceeding equivalence of 14 weeks gestation.

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)
Yes- central administration
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation with computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample Size Calculation: Based on 5% significance level and 80% power to detect a 20% reduction in operating time based on a mean operating time of 70 minutes and a standard deviation of 24 minutes.

Analysis Plan: Data will be analysed with Chi square test and two sample t-test using the R statistical package.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/02/2019
Actual
4/02/2019
Date of last participant enrolment
Anticipated
1/08/2021
Actual
Date of last data collection
Anticipated
1/09/2021
Actual
Sample size
Target
96
Accrual to date
31
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 12905 0
Blacktown Hospital - Blacktown
Recruitment hospital [2] 12906 0
Norwest Private Hospital - Bella Vista
Recruitment hospital [3] 12907 0
Nepean Private Hospital - Kingswood
Recruitment postcode(s) [1] 25382 0
2148 - Blacktown
Recruitment postcode(s) [2] 25383 0
2153 - Bella Vista
Recruitment postcode(s) [3] 25384 0
2474 - Kingswood

Funding & Sponsors
Funding source category [1] 301654 0
Other Collaborative groups
Name [1] 301654 0
Sydney West Advanced Pelvic Surgery (SWAPS)
Country [1] 301654 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Australasian Gynaecological Endoscopy & Surgery Society (AGES)
Address
PO Box 717
Indooroopilly QLD 4068
Country
Australia
Secondary sponsor category [1] 301366 0
None
Name [1] 301366 0
Address [1] 301366 0
Country [1] 301366 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302375 0
Western Sydney Local Health District (WSLHD)
Ethics committee address [1] 302375 0
WSLHD Research Governance Office
Darcy Rd.
Westmead NSW 2145
Ethics committee country [1] 302375 0
Australia
Date submitted for ethics approval [1] 302375 0
28/02/2017
Approval date [1] 302375 0
11/08/2017
Ethics approval number [1] 302375 0
HREC/17/WMEAD/19 (5001)

Summary
Brief summary
The colpotomiser is a key instrument utilised at laparoscopic hysterectomy. In the Western Sydney Local Health District (WSLHD), the Rumi II® [Cooper Surgical] and the Biswas [Storz] are two commonly used uterine manipulators during laparoscopic hysterectomy. Both of these devices are FDA approved and already in general use. Currently, there are multiple published articles evaluating the effectiveness of individual colpotomisers at hysterectomy, however there are few randomised controlled trials comparing devices, and none comparing Rumi II and Biswas.

The study aims to recruit 96 patients over a 12 month period. The primary outcome is operative time. Secondary outcomes include standard peri-operative measures including blood loss, blood transfusion, complications, readmission, return to theatre, and conversion to an alternative colpotomiser device. A subjective surgeon assessment using a Likert scale will assess the ease of insertion, manipulation, surgical access and maintenance of pneumoperitoneum.
Trial website
Trial related presentations / publications
Our intention is to present the findings at an AGES meeting and submit for publication in the Journal of Minimally Invasive Gynecology.
Public notes

Contacts
Principal investigator
Name 90010 0
A/Prof Harry Merkur
Address 90010 0
SWAPS
6 Kempsey St.
Blacktown NSW 2148
Country 90010 0
Australia
Phone 90010 0
+61 2 9622 8000
Fax 90010 0
Email 90010 0
[email protected]
Contact person for public queries
Name 90011 0
Dr Andrew McIntyre
Address 90011 0
Blacktown Hospital
Department of Obstetrics & Gynaecology
18 Blacktown Rd
Blacktown NSW 2148
Country 90011 0
Australia
Phone 90011 0
+61 2 9881 8000
Fax 90011 0
Email 90011 0
[email protected]
Contact person for scientific queries
Name 90012 0
Dr Andrew McIntyre
Address 90012 0
Blacktown Hospital
Department of Obstetrics & Gynaecology
18 Blacktown Rd
Blacktown NSW 2148
Country 90012 0
Australia
Phone 90012 0
+61 2 9881 8000
Fax 90012 0
Email 90012 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.