The Implementation of MinimAlly Invasive Hysterectomy Trial

Female Reproductive Problem Clinical Trial

— IMAGINE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03617354
• Other study ID #: IMAGINE
• Status: Completed
• Start date: March 29, 2017
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2023
• Source: Queensland Centre for Gynaecological Cancer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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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Related Conditions & MeSH terms

• Female Reproductive Problem

Intervention

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

Locations

Country	Name	City	State
Australia	Redcliffe Hospital	Brisbane	Queensland
Australia	Cairns Hospital	Cairns	Queensland
Australia	Ipswich Hospital	Ipswich	Queensland
Australia	Mackay Base Hospital	Mackay	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
Queensland Centre for Gynaecological Cancer

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in proportion of hysterectomy	proportion of hysterectomies performed abdominally through TAH comparing pre-intervention baseline and post-intervention rates	36 months
Secondary	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
Secondary	Length of hospital stays	days	36 months
Secondary	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
Secondary	Trainee Surgeon proficiency with Total Laparoscopic Hysterectomy	Proficiency is assessed using the Laparoscopic Competency Assessment Tool (L-CAT)	36 months