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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02167672




Registration number
NCT02167672
Ethics application status
Date submitted
16/04/2014
Date registered
19/06/2014
Date last updated
20/03/2019

Titles & IDs
Public title
Barriers for the Uptake of LaparoScopic Hysterectomy
Scientific title
What Would it Take to Reduce the Proportion of Women Who Have a Hysterectomy Via an Open Abdominal Approach in Australia?
Secondary ID [1] 0 0
LIgHT
Universal Trial Number (UTN)
Trial acronym
LIgHT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hysterectomy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Consumers - Women who have had a Hysterectomy in the previous 2 years

Doctors - Obstetricians and Gynaecologists
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Questionnaire will identify barriers
Timepoint [1] 0 0
12 months

Eligibility
Key inclusion criteria
- Obstetricians and Gynaecologists or Women who have had a hysterectomy in the previous
2 years
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Women who have had a hysterectomy more than 2 years ago

- Women who had a hysterectomy for cancerous conditions

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2018
Sample size
Target
1200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
University of Queensland - Brisbane
Recruitment postcode(s) [1] 0 0
4029 - Brisbane

Funding & Sponsors
Primary sponsor type
Other
Name
Queensland Centre for Gynaecological Cancer
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Queensland University of Technology
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02167672
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andreas Obermair
Address 0 0
Queensland Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02167672