The Implementation of MinimAlly Invasive Hysterectomy Trial

Study Overview
=================
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

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

Conditions
-----------------
Female Reproductive Problem

Intervention / Treatment
-----------------
* Procedure: Total Laparoscopic Hysterectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
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. -
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Trainee Gynaecologists<br>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. | Procedure: Total Laparoscopic Hysterectomy<br>* The trainee gynaecologists are undertaking a training program in performing Total Laparoscopic Hysterectomy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in proportion of hysterectomy | proportion of hysterectomies performed abdominally through TAH comparing pre-intervention baseline and post-intervention rates | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Length of hospital stays | days | 36 months | 
| 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 | 
| Trainee Surgeon proficiency with Total Laparoscopic Hysterectomy | Proficiency is assessed using the Laparoscopic Competency Assessment Tool (L-CAT) | 36 months |