HysterectomyLIgHTNCT02167672
Barriers for the Uptake of LaparoScopic Hysterectomy
An observational study of Hysterectomy, run by Queensland Centre for Gynaecological Cancer at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hysterectomy
- How many people
- 1,200 participants
- Where
- 1 siteAustralia
- Study dates
- Apr 2014to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Members of RANZCOG community sample
Who may be able to join
- Obstetricians and Gynaecologists or Women who have had a hysterectomy in the previous 2 years
Who cannot join
- Women who have had a hysterectomy more than 2 years ago
- Women who had a hysterectomy for cancerous conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Hysterectomy
- Keywords
- total abdominal hysterectomy, total laparoscopic hysterectomy, vaginal hysterectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Consumers | Women who have had a Hysterectomy in the previous 2 years | |
| Doctors | Obstetricians and Gynaecologists |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire will identify barriers
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2016
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HysterectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queensland Centre for Gynaecological Cancer
- Sponsor type
- Other government
- Collaborators
- Queensland University of Technology
- Responsible party
- Sponsor
- Investigators
- Andreas Obermair, Study chair, Queensland Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02167672
- Sponsor's protocol ID
- LIgHT
- Acronym
- LIgHT
- Status last verified
- Mar 2019
- First submitted
- 16 Apr 2014
- Last updated
- 20 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Would it Take to Reduce the Proportion of Women Who Have a Hysterectomy Via an Open Abdominal Approach in Australia?
- ClinicalTrials.gov ID
- NCT02167672
- Acronym / sponsor ID
- LIgHT / LIgHT
- Conditions
- Hysterectomy
- Keywords
- total abdominal hysterectomy, total laparoscopic hysterectomy, vaginal hysterectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Queensland Centre for Gynaecological CancerOther government
- Collaborators
- Queensland University of Technology
- Study start
- Apr 2014 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 19 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Consumers | – | –Women who have had a Hysterectomy in the previous 2 years |
| Doctors | – | –Obstetricians and Gynaecologists |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Members of RANZCOG community sample
Key inclusion criteria (1 listed)
- Obstetricians and Gynaecologists or Women who have had a hysterectomy in the previous 2 years
Key exclusion criteria (2 listed)
- Women who have had a hysterectomy more than 2 years ago
- Women who had a hysterectomy for cancerous conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Questionnaire will identify barriers
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Obermair study chair
Queensland Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hysterectomy, run by Queensland Centre for Gynaecological Cancer at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire will identify barriers (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2019.