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
• Conditions: Female Reproductive Problem
• Intervention / Treatment: Procedure: Total Laparoscopic Hysterectomy

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Australia
  • 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

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.

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Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Procedure: Total Laparoscopic Hysterectomy; 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	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	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	days	36 months
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.	36 months
Trainee Surgeon proficiency with Total Laparoscopic Hysterectomy	Proficiency is assessed using the Laparoscopic Competency Assessment Tool (L-CAT)	36 months

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Obermair A, Armfield NR, Graves N, Gebski V, Hanna GB, Coleman MG, Hughes A, Janda M. How to train practising gynaecologists in total laparoscopic hysterectomy: protocol for the stepped-wedge IMAGINE trial. BMJ Open. 2019 May 9;9(5):e027155. doi: 10.1136/bmjopen-2018-027155.

Study record dates

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