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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03617354
Ethics application status
Date submitted
24/07/2018
Date registered
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 - 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.


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
Timepoint [1] 0 0
36 months
Secondary outcome [1] 0 0
Adverse Events
Timepoint [1] 0 0
36 months
Secondary outcome [2] 0 0
Length of hospital stays
Timepoint [2] 0 0
36 months
Secondary outcome [3] 0 0
Cost effectiveness
Timepoint [3] 0 0
36 months
Secondary outcome [4] 0 0
Trainee Surgeon proficiency with Total Laparoscopic Hysterectomy
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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/03/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/12/2022
Sample size
Target
Accrual to date
Final
10
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 hospital [4] 0 0
Mackay Base Hospital - Mackay
Recruitment postcode(s) [1] 0 0
4020 - Brisbane
Recruitment postcode(s) [2] 0 0
4870 - Cairns
Recruitment postcode(s) [3] 0 0
4305 - Ipswich
Recruitment postcode(s) [4] 0 0
4740 - Mackay

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03617354