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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03617354
Other study ID # IMAGINE
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 29, 2017
Est. completion date December 31, 2022

Study information

Verified date April 2023
Source Queensland Centre for Gynaecological Cancer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date December 31, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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. -

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Total Laparoscopic Hysterectomy
The trainee gynaecologists are undertaking a training program in performing Total Laparoscopic Hysterectomy

Locations

Country Name City State
Australia Redcliffe Hospital Brisbane Queensland
Australia Cairns Hospital Cairns Queensland
Australia Ipswich Hospital Ipswich Queensland
Australia Mackay Base Hospital Mackay Queensland

Sponsors (1)

Lead Sponsor Collaborator
Queensland Centre for Gynaecological Cancer

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in proportion of hysterectomy proportion of hysterectomies performed abdominally through TAH comparing pre-intervention baseline and post-intervention rates 36 months
Secondary 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
Secondary Length of hospital stays days 36 months
Secondary 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
Secondary Trainee Surgeon proficiency with Total Laparoscopic Hysterectomy Proficiency is assessed using the Laparoscopic Competency Assessment Tool (L-CAT) 36 months
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