Barriers for the Uptake of LaparoScopic Hysterectomy

NCT ID: NCT02167672

Last Updated: 2019-03-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2018-12-31

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 In brief, a common but outdated operation is still performed regularly causing not only unnecessary pain, surgical adverse events and longer hospital stay but also increased healthcare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

Conditions

Hysterectomy

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Study Groups

Consumers

Women who have had a Hysterectomy in the previous 2 years

No interventions assigned to this group

Doctors

Obstetricians and Gynaecologists

No interventions assigned to this group

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Queensland University of Technology

OTHER

Sponsor Role: collaborator

Queensland Centre for Gynaecological Cancer

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andreas Obermair

Role: STUDY_CHAIR

Queensland Health

Locations

University of Queensland

Brisbane, Queensland, Australia

Countries

Australia

Other Identifiers

LIgHT

Identifier Type: -

Identifier Source: org_study_id