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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03617354




Registration number
NCT03617354
Ethics application status
Date submitted
24/07/2018
Date registered
6/08/2018
Date last updated
6/08/2018

Titles & IDs
Public title
The Implementation of MinimAlly Invasive Hysterectomy Trial
Scientific title
A Stepped Wedge Cluster Trial to Implement and Evaluate a Model for Training Practising Gynaecologists in Total Laparoscopic Hysterectomy
Secondary ID [1] 0 0
IMAGINE
Universal Trial Number (UTN)
Trial acronym
IMAGINE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Female Reproductive Problem 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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

Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in proportion of hysterectomy - proportion of hysterectomies performed abdominally through TAH comparing pre-intervention baseline and post-intervention rates
Timepoint [1] 0 0
36 months
Secondary outcome [1] 0 0
Adverse Events - 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
Timepoint [1] 0 0
36 months
Secondary outcome [2] 0 0
Length of hospital stays - days
Timepoint [2] 0 0
36 months
Secondary outcome [3] 0 0
Cost effectiveness - 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.
Timepoint [3] 0 0
36 months
Secondary outcome [4] 0 0
Trainee Surgeon proficiency with Total Laparoscopic Hysterectomy - Proficiency is assessed using the Laparoscopic Competency Assessment Tool (L-CAT)
Timepoint [4] 0 0
36 months

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.

-
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
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)
QLD
Recruitment hospital [1] 0 0
Redcliffe Hospital - Brisbane
Recruitment hospital [2] 0 0
Cairns Hospital - Cairns
Recruitment hospital [3] 0 0
Ipswich Hospital - Ipswich
Recruitment postcode(s) [1] 0 0
4020 - Brisbane
Recruitment postcode(s) [2] 0 0
4870 - Cairns
Recruitment postcode(s) [3] 0 0
4305 - Ipswich

Funding & Sponsors
Primary sponsor type
Other
Name
Queensland Centre for Gynaecological Cancer
Address
Country

Ethics approval
Ethics application status

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
Trial website
https://clinicaltrials.gov/show/NCT03617354
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andreas Obermair
Address 0 0
Queensland Centre for Gynaecological Cancer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Trudi Cattley
Address 0 0
Country 0 0
Phone 0 0
0736460447
Fax 0 0
Email 0 0
trudi.cattley@health.qld.gov.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03617354