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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02167672
Registration number
NCT02167672
Ethics application status
Date submitted
16/04/2014
Date registered
19/06/2014
Titles & IDs
Public title
Barriers for the Uptake of LaparoScopic Hysterectomy
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Scientific title
What Would it Take to Reduce the Proportion of Women Who Have a Hysterectomy Via an Open Abdominal Approach in Australia?
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Secondary ID [1]
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LIgHT
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Universal Trial Number (UTN)
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Trial acronym
LIgHT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hysterectomy
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Condition category
Condition code
Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Consumers - Women who have had a Hysterectomy in the previous 2 years
Doctors - Obstetricians and Gynaecologists
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Questionnaire will identify barriers
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Assessment method [1]
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Timepoint [1]
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12 months
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Eligibility
Key inclusion criteria
* Obstetricians and Gynaecologists or Women who have had a hysterectomy in the previous 2 years
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* Women who have had a hysterectomy more than 2 years ago
* Women who had a hysterectomy for cancerous conditions
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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2018
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Sample size
Target
1200
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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University of Queensland - Brisbane
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Recruitment postcode(s) [1]
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4029 - Brisbane
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Funding & Sponsors
Primary sponsor type
Government body
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Name
Queensland Centre for Gynaecological Cancer
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Queensland University of Technology
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT02167672
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Andreas Obermair
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Address
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Queensland Health
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02167672