NCT02167672

Brief Summary

Hysterectomy (surgical removal of the uterus) is the most common major gynaecological operation in women in developed countries. In Queensland, 6000 women require a hysterectomy for irregular periods, benign tumours or pelvic pain every year. Surgical approaches to surgical removal of the uterus (womb) include Laparoscopic Hysterectomy (LH), Vaginal Hysterectomy (VH) and Abdominal Hysterectomy through an abdominal incision (AH). It is widely accepted that LH and VH are less invasive surgical procedures, cause less bleeding, surgical complications and pain and are associated with quicker recovery from surgery than the more invasive AH. In a clinical trial comparing LH and AH we recently demonstrated that LH outperforms AH with regards to cost effectiveness causing less total health-services cost than AH. Implementation of LH in Queensland could save $9.8 million every year. Despite the evidence for LH and VH, 2600 hysterectomies (43%) are still performed through an open, abdominal incision. In brief, a common but outdated operation is still performed regularly causing not only unnecessary pain, surgical adverse events and longer hospital stay but also increased healthcare costs. This study will assess reasons why a significant number of gynaecologists and patients prefer AH over LH (Barriers to the uptake of laparoscopic hysterectomy). We will survey specialist gynaecologists as well as patients who have had a hysterectomy for different health reasons. Based on the information from the survey the investigators will develop an intervention to increase the rate of laparoscopic hysterectomies in Queensland and pilot test it.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 19, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 20, 2019

Status Verified

March 1, 2019

Enrollment Period

2 years

First QC Date

April 16, 2014

Last Update Submit

March 18, 2019

Conditions

Keywords

total abdominal hysterectomy, total laparoscopic hysterectomy, vaginal hysterectomy

Outcome Measures

Primary Outcomes (1)

  • Questionnaire will identify barriers

    12 months

Study Arms (2)

Consumers

Women who have had a Hysterectomy in the previous 2 years

Doctors

Obstetricians and Gynaecologists

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Members of RANZCOG community sample

You may qualify if:

  • Obstetricians and Gynaecologists or Women who have had a hysterectomy in the previous 2 years

You may not qualify if:

  • Women who have had a hysterectomy more than 2 years ago
  • Women who had a hysterectomy for cancerous conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Queensland

Brisbane, Queensland, 4029, Australia

Location

Study Officials

  • Andreas Obermair

    Queensland Health

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2014

First Posted

June 19, 2014

Study Start

April 1, 2014

Primary Completion

April 1, 2016

Study Completion

December 1, 2018

Last Updated

March 20, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations