- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03617354
The Implementation of MinimAlly Invasive Hysterectomy Trial (IMAGINE)
A Stepped Wedge Cluster Trial to Implement and Evaluate a Model for Training Practising Gynaecologists in Total Laparoscopic Hysterectomy
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Queensland
-
Brisbane, Queensland, Australia, 4020
- Redcliffe Hospital
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Cairns, Queensland, Australia, 4870
- Cairns Hospital
-
Ipswich, Queensland, Australia, 4305
- Ipswich Hospital
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Mackay, Queensland, Australia, 4740
- Mackay Base Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Surgical training program participants Inclusion criteria
- 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.
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Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Trainee Gynaecologists
|
The trainee gynaecologists are undertaking a training program in performing Total Laparoscopic Hysterectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in proportion of hysterectomy
Time Frame: 36 months
|
proportion of hysterectomies performed abdominally through TAH comparing pre-intervention baseline and post-intervention rates
|
36 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Events
Time Frame: 36 months
|
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
|
36 months
|
Length of hospital stays
Time Frame: 36 months
|
days
|
36 months
|
Cost effectiveness
Time Frame: 36 months
|
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.
|
36 months
|
Trainee Surgeon proficiency with Total Laparoscopic Hysterectomy
Time Frame: 36 months
|
Proficiency is assessed using the Laparoscopic Competency Assessment Tool (L-CAT)
|
36 months
|
Collaborators and Investigators
Investigators
- Study Chair: Andreas Obermair, Queensland Centre for Gynaecological Cancer
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- iMAGINE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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