The Implementation of MinimAlly Invasive Hysterectomy Trial
- Conditions
- Female Reproductive Problem
- Interventions
- Procedure: Total Laparoscopic Hysterectomy
- Registration Number
- NCT03617354
- Lead Sponsor
- Queensland Centre for Gynaecological Cancer
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Trainee Gynaecologists Total Laparoscopic Hysterectomy 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.
- Primary Outcome Measures
Name Time Method Change in proportion of hysterectomy 36 months proportion of hysterectomies performed abdominally through TAH comparing pre-intervention baseline and post-intervention rates
- Secondary Outcome Measures
Name Time Method Cost effectiveness 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.
Adverse Events 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
Length of hospital stays 36 months days
Trainee Surgeon proficiency with Total Laparoscopic Hysterectomy 36 months Proficiency is assessed using the Laparoscopic Competency Assessment Tool (L-CAT)
Trial Locations
- Locations (4)
Ipswich Hospital
🇦🇺Ipswich, Queensland, Australia
Cairns Hospital
🇦🇺Cairns, Queensland, Australia
Redcliffe Hospital
🇦🇺Brisbane, Queensland, Australia
Mackay Base Hospital
🇦🇺Mackay, Queensland, Australia