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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date March 2019
Source Queensland Centre for Gynaecological Cancer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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 In brief, a common but outdated operation is still performed regularly causing not only unnecessary pain, surgical adverse events and longer hospital stay but also increased healthcare costs.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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Australia University of Queensland Brisbane Queensland

Sponsors (2)

Lead Sponsor Collaborator
Queensland Centre for Gynaecological Cancer Queensland University of Technology

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Questionnaire will identify barriers 12 months
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