Hysterectomy Clinical Trial
— LIgHTOfficial title:
What Would it Take to Reduce the Proportion of Women Who Have a Hysterectomy Via an Open Abdominal Approach in Australia?
NCT number | NCT02167672 |
Other study ID # | LIgHT |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 2014 |
Est. completion date | December 2018 |
Verified date | March 2019 |
Source | Queensland Centre for Gynaecological Cancer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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 In brief, a common but outdated operation is still performed regularly causing not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.
Status | Completed |
Enrollment | 1200 |
Est. completion date | December 2018 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Australia | University of Queensland | Brisbane | Queensland |
Lead Sponsor | Collaborator |
---|---|
Queensland Centre for Gynaecological Cancer | Queensland University of Technology |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Questionnaire will identify barriers | 12 months |
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