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The Implementation of MinimAlly Invasive Hysterectomy Trial

A Stepped Wedge Cluster Trial to Implement and Evaluate a Model for Training Practising Gynaecologists in Total Laparoscopic Hysterectomy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03617354
Acronym
IMAGINE
Enrollment
10
Registered
2018-08-06
Start date
2017-03-29
Completion date
2022-12-31
Last updated
2023-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Female Reproductive Problem

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

Interventions

PROCEDURETotal Laparoscopic Hysterectomy

The trainee gynaecologists are undertaking a training program in performing Total Laparoscopic Hysterectomy

Sponsors

Queensland Centre for Gynaecological Cancer
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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. \-

Design outcomes

Primary

MeasureTime frameDescription
Change in proportion of hysterectomy36 monthsproportion of hysterectomies performed abdominally through TAH comparing pre-intervention baseline and post-intervention rates

Secondary

MeasureTime frameDescription
Adverse Events36 monthsconversion 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
Length of hospital stays36 monthsdays
Cost effectiveness36 monthsCost 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.
Trainee Surgeon proficiency with Total Laparoscopic Hysterectomy36 monthsProficiency is assessed using the Laparoscopic Competency Assessment Tool (L-CAT)

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026