The Implementation of MinimAlly Invasive Hysterectomy Trial

NCT03617354 | Completed

• 1 other identifier: IMAGINE
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 4

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

Conditions

Female Reproductive Problem

Outcome Measures

Primary Outcomes (1)

• Change in proportion of hysterectomy

  proportion of hysterectomies performed abdominally through TAH comparing pre-intervention baseline and post-intervention rates

  36 months

Secondary Outcomes (4)

• Adverse Events

  36 months

• Length of hospital stays

  36 months

• Cost effectiveness

  36 months

• Trainee Surgeon proficiency with Total Laparoscopic Hysterectomy

  36 months

Study Arms (1)

Trainee Gynaecologists

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.

Procedure: Total Laparoscopic Hysterectomy

Interventions

Total Laparoscopic Hysterectomy PROCEDURE

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

Trainee Gynaecologists

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Trainee gynaecologists

You may qualify if:

• RANZCOG accredited O\&G specialists who are proficient in RANZCOG laparoscopic skills level 3 or higher;
• 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).
• Will be able to attend each of the 10 training days.

Sponsors & Collaborators

• Queensland Centre for Gynaecological Cancer: lead

Study Sites (4)

Redcliffe Hospital

Brisbane, Queensland, 4020, Australia

Location

Cairns Hospital

Cairns, Queensland, 4870, Australia

Location

Ipswich Hospital

Ipswich, Queensland, 4305, Australia

Location

Mackay Base Hospital

Mackay, Queensland, 4740, Australia

Location

Related Publications (1)

• 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.

  PMID: 31072858 DERIVED

Study Officials

• Andreas Obermair

  Queensland Centre for Gynaecological Cancer

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2018
• First Posted: August 6, 2018
• Study Start: March 29, 2017
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (4)