Clinical trial NCT03617354: The Implementation of MinimAlly Invasive Hysterectomy Trial
Official title: A Stepped Wedge Cluster Trial to Implement and Evaluate a Model for Training Practising Gynaecologists in Total Laparoscopic Hysterectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Female Reproductive Problem
Lead sponsor: Queensland Centre for Gynaecological Cancer
Sponsor class: OTHER_GOV
First posted: 2018-08-06
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Trainee gynaecologists

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


Eligibility criteria: 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.

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Primary outcomes:
measure: Change in proportion of hysterectomy
timeFrame: 36 months
Secondary outcomes:
measure: Adverse Events
timeFrame: 36 months
measure: Length of hospital stays
timeFrame: 36 months
measure: Cost effectiveness
timeFrame: 36 months
measure: Trainee Surgeon proficiency with Total Laparoscopic Hysterectomy
timeFrame: 36 months
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Redcliffe Hospital
state: Queensland
city: Cairns
country: Australia
facility: Cairns Hospital
state: Queensland
city: Ipswich
country: Australia
facility: Ipswich Hospital
state: Queensland
city: Mackay
country: Australia
facility: Mackay Base Hospital
state: Queensland
Study officials:
affiliation: Queensland Centre for Gynaecological Cancer
name: Andreas Obermair
role: STUDY_CHAIR
References:
citation: Obermair A, Armfield NR, Graves N, Gebski V, Hanna GB, Coleman MG, Hughes A, Janda M. How to train practising gynaecologists in total laparoscopic hysterectomy: protocol for the stepped-wedge IMAGINE trial. BMJ Open. 2019 May 9;9(5):e027155. doi: 10.1136/bmjopen-2018-027155.