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OpenTrials
Completed

NCT Number: NCT03617354

The Implementation of MinimAlly Invasive Hysterectomy Trial

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

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Key information

Conditions

Female Reproductive Problem

Sex eligibility

All sexes

Study type

Observational

Primary location

Redcliffe Hospital, Brisbane, Queensland, Australia

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Total laparoscopic hysterectomy

Procedure

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

Primary outcomes

  1. Change in proportion of hysterectomy

    Time frame: 36 months

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

Secondary outcomes

  1. 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

  2. Length of hospital stays

    Time frame: 36 months

    days

  3. 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.

  4. Trainee Surgeon proficiency with Total Laparoscopic Hysterectomy

    Time frame: 36 months

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

Sponsors and collaborators

Lead sponsor

Queensland Centre for Gynaecological Cancer

Other Gov

Registry information

Official study title

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

Acronym: IMAGINE

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
Aug 6, 2018
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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