- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02167672
Barriers for the Uptake of LaparoScopic Hysterectomy (LIgHT)
What Would it Take to Reduce the Proportion of Women Who Have a Hysterectomy Via an Open Abdominal Approach in Australia?
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 In brief, a common but outdated operation is still performed regularly causing not only unnecessary pain, surgical adverse events and longer hospital stay but also increased healthcare costs.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.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Queensland
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Brisbane, Queensland, Australia, 4029
- University of Queensland
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Obstetricians and Gynaecologists or Women who have had a hysterectomy in the previous 2 years
Exclusion Criteria:
- Women who have had a hysterectomy more than 2 years ago
- Women who had a hysterectomy for cancerous conditions
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Consumers
Women who have had a Hysterectomy in the previous 2 years
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Doctors
Obstetricians and Gynaecologists
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Questionnaire will identify barriers
Time Frame: 12 months
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12 months
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Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Andreas Obermair, Queensland Health
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- LiGHT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
Università degli Studi di FerraraRecruiting
-
GCS Ramsay Santé pour l'Enseignement et la RechercheCompleted
-
University Hospitals Cleveland Medical CenterWithdrawn
-
Atlantic Health SystemUnknownHysterectomyUnited States
-
Brigham and Women's HospitalMassachusetts General HospitalCompletedHysterectomyUnited States
-
Case Comprehensive Cancer CenterWithdrawnHysterectomy
-
Cairo UniversityUnknown
-
Mayo ClinicTerminated