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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/NCT03617354
Registration number
NCT03617354
Ethics application status
Date submitted
24/07/2018
Date registered
6/08/2018
Date last updated
18/04/2023
Titles & IDs
Public title
The Implementation of MinimAlly Invasive Hysterectomy Trial
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Scientific title
A Stepped Wedge Cluster Trial to Implement and Evaluate a Model for Training Practising Gynaecologists in Total Laparoscopic Hysterectomy
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Secondary ID [1]
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IMAGINE
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Universal Trial Number (UTN)
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Trial acronym
IMAGINE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Female Reproductive Problem
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Condition category
Condition code
Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Surgery - Total Laparoscopic Hysterectomy
Trainee Gynaecologists - RANZCOG accredited O&G specialists who are proficient in RANZCOG laparoscopic skills level 3 or higher;
Surgical capabilities will be assessed using The Global Operative Assessment of Laparoscopic Skills (GOALS) Tool which is an adapted GOALS tool for hysterectomy. GOALS measures depth perception, bimanual dexterity, efficiency, tissue handling and surgeon autonomy each on a 5 point Likert scale. An experienced mentor will assess each surgeon using this scale and skills will be validated against objective outcomes (surgical adverse events recorded in the baseline period).
Will be able to attend each of the 10 training days.
Treatment: Surgery: Total Laparoscopic Hysterectomy
The trainee gynaecologists are undertaking a training program in performing Total Laparoscopic Hysterectomy
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in proportion of hysterectomy
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Assessment method [1]
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proportion of hysterectomies performed abdominally through TAH comparing pre-intervention baseline and post-intervention rates
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Timepoint [1]
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36 months
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Secondary outcome [1]
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Adverse Events
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Assessment method [1]
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conversion from TLH to TAH, any anaesthetic incident, intraoperative visceral injury, red cell transfusions, hospital stay greater than 7 days, incidental finding of a malignancy, unplanned readmission, ICU admission or return to theatre, postoperative PE or DVT, development of a fistula, vault haematoma, vaginal vault dehiscence or pelvic infection
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Timepoint [1]
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36 months
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Secondary outcome [2]
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Length of hospital stays
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Assessment method [2]
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days
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Timepoint [2]
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36 months
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Secondary outcome [3]
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Cost effectiveness
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Assessment method [3]
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Cost effectiveness via assessment of: theatre staffing costs; equipment and consumables; Medicare Benefits Schedule items for surgical and anaesthetics fees; costs of health services used after surgery; costs of bed-days; and costs due to readmissions or visits to the emergency department.
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Timepoint [3]
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36 months
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Secondary outcome [4]
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Trainee Surgeon proficiency with Total Laparoscopic Hysterectomy
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Assessment method [4]
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Proficiency is assessed using the Laparoscopic Competency Assessment Tool (L-CAT)
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Timepoint [4]
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36 months
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Eligibility
Key inclusion criteria
Surgical training program participants Inclusion criteria
1. RANZCOG accredited O&G specialists who are proficient in RANZCOG laparoscopic skills
level 3 or higher;
2. Surgical capabilities will be assessed using The Global Operative Assessment of
Laparoscopic Skills (GOALS) Tool which is an adapted GOALS tool for hysterectomy.
GOALS measures depth perception, bimanual dexterity, efficiency, tissue handling and
surgeon autonomy each on a 5 point Likert scale. An experienced mentor will assess
each surgeon using this scale and skills will be validated against objective outcomes
(surgical adverse events recorded in the baseline period).
3. Will be able to attend each of the 10 training days.
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
29/03/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/12/2022
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Sample size
Target
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Accrual to date
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Final
10
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Redcliffe Hospital - Brisbane
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Recruitment hospital [2]
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Cairns Hospital - Cairns
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Recruitment hospital [3]
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Ipswich Hospital - Ipswich
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Recruitment hospital [4]
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Mackay Base Hospital - Mackay
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Recruitment postcode(s) [1]
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4020 - Brisbane
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Recruitment postcode(s) [2]
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4870 - Cairns
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Recruitment postcode(s) [3]
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4305 - Ipswich
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Recruitment postcode(s) [4]
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4740 - Mackay
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Funding & Sponsors
Primary sponsor type
Other
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Name
Queensland Centre for Gynaecological Cancer
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Removal of the uterus (hysterectomy) is the most commonly performed major gynaecological
procedure in women. Obstetricians and gynaecologist (O&G) surgeons conduct the majority of
hysterectomies. Surgical approaches to removal of the uterus include laparoscopic
hysterectomy, vaginal hysterectomy with or without laparoscopic assistance and open
hysterectomy through an abdominal incision. It is widely accepted that laparoscopic
hysterectomy and vaginal hysterectomy are less invasive procedures, cause fewer surgical
complications, less postoperative pain, require a shorter hospital stay and are associated
with quicker recovery than abdominal hysterectomy. In Australia and despite the evidence,
Total Abdominal Hysterectomy (TAH) rates are unreasonably high (~40%) and only 13% of all
hysterectomies are done via Total Laparoscopic Hysterectomy (TLH) in Australia.
This study aims to implement and evaluate a training program in TLH for gynaecologists. The
potential benefits to the community are:
- A reduction in the incidence of overall surgical adverse events in patients receiving a
hysterectomy
- A reduction in the length of hospital stay for patients requiring a hysterectomy
- A reduction in the direct hospital costs for hysterectomy
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03617354
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Andreas Obermair
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Address
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Queensland Centre for Gynaecological Cancer
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03617354
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