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

Completed

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Queensland
      • Brisbane, Queensland, Australia, 4020
        • Redcliffe Hospital
      • Cairns, Queensland, Australia, 4870
        • Cairns Hospital
      • Ipswich, Queensland, Australia, 4305
        • Ipswich Hospital
      • Mackay, Queensland, Australia, 4740
        • Mackay Base Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Trainee gynaecologists

Description

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.

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Andreas Obermair, Queensland Centre for Gynaecological Cancer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2017

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

July 24, 2018

First Submitted That Met QC Criteria

July 31, 2018

First Posted (Actual)

August 6, 2018

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 13, 2023

Last Verified

April 1, 2023

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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