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Clinical Trials/NCT03617354
NCT03617354
Completed
Not Applicable

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

Queensland Centre for Gynaecological Cancer4 sites in 1 country10 target enrollmentStarted: March 29, 2017Last updated:

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)

Investigators

Sponsor
Queensland Centre for Gynaecological Cancer
Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (4)

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