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Female Reproductive ProblemIMAGINENCT03617354

The Implementation of MinimAlly Invasive Hysterectomy Trial

An observational study of Female Reproductive Problem, run by Queensland Centre for Gynaecological Cancer at 4 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Female Reproductive Problem
What is being tested?
Total Laparoscopic Hysterectomy
Type of treatment
Surgery or procedure
How many people
10 participants
Where
4 sitesAustralia
Study dates
29 Mar 2017to 31 Dec 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Trainee gynaecologists

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. -

Trial locations and contacts

4 sites in 1 country.

Australia4 sites

  • Redcliffe Hospital

    Brisbane, Queensland, 4020

  • Cairns Hospital

    Cairns, Queensland, 4870

  • Ipswich Hospital

    Ipswich, Queensland, 4305

  • Mackay Base Hospital

    Mackay, Queensland, 4740

Other trials in Australia

About this study

Official title: 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
Being tested
Total Laparoscopic Hysterectomy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Total Laparoscopic HysterectomyProcedure or surgery

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

Study groups in NCT03617354
Study groupRoleWhat they receive
Trainee Gynaecologists1. 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.
Receives: Procedure: Total Laparoscopic Hysterectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in proportion of hysterectomy

    proportion of hysterectomies performed abdominally through TAH comparing pre-intervention baseline and post-intervention rates

    Measured: 36 months

Secondary outcomes (4)

  1. 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

    Measured: 36 months

  2. Length of hospital stays

    days

    Measured: 36 months

  3. 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.

    Measured: 36 months

  4. Trainee Surgeon proficiency with Total Laparoscopic Hysterectomy

    Proficiency is assessed using the Laparoscopic Competency Assessment Tool (L-CAT)

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2018
  2. Study start29 Mar 2017
  3. Primary completion31 Dec 2021
  4. Study completion31 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03617354
Sponsor's protocol ID
IMAGINE
Acronym
IMAGINE
Status last verified
Apr 2023
First submitted
24 Jul 2018
Last updated
18 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 31072858

Questions about this trial

What is this clinical trial studying?

An observational study of Female Reproductive Problem, run by Queensland Centre for Gynaecological Cancer at 4 sites in Australia.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in proportion of hysterectomy (time frame: 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03617354, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.

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