A Stepped Wedge Cluster Trial to Implement and Evaluate a Model for Training Practising Gynaecologists in Total Laparoscopic Hysterectomy
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Queensland Centre for Gynaecological Cancer
- Enrollment
- 10
- Locations
- 4
- Primary Endpoint
- Change in proportion of hysterectomy
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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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
- Cost effectiveness(36 months)
- Adverse Events(36 months)
- Length of hospital stays(36 months)
- Trainee Surgeon proficiency with Total Laparoscopic Hysterectomy(36 months)