The Implementation of MinimAlly Invasive Hysterectomy Trial (IMAGINE)

Queensland Centre for Gynaecological Cancer

Status: Completed

Conditions: Female Reproductive Problem

Treatments: Procedure: Total Laparoscopic Hysterectomy

Study type: Observational

Funder types: Other

Identifiers

NCT03617354

IMAGINE

Details and patient eligibility

About

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

Enrollment: 10 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

10 participants in 1 patient group

Trainee Gynaecologists

Description:

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.

Treatment:

Procedure: Total Laparoscopic Hysterectomy