Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000502235
Ethics application status
Approved
Date submitted
14/03/2018
Date registered
6/04/2018
Date last updated
2/03/2021
Date data sharing statement initially provided
2/03/2021
Date results information initially provided
2/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Review of sacrospinous fixation surgery for treatment of vaginal prolapse in Bangladesh and Nepal
Scientific title
Prolapse recurrence following sacrospinous colpopexy for the management of pelvic organ prolapse in Bangladesh and Nepal
Secondary ID [1] 294306 0
nil known
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
pelvic organ prolapse 307013 0
Condition category
Condition code
Surgery 306108 306108 0 0
Surgical techniques
Reproductive Health and Childbirth 306109 306109 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Prolapse usually presents as a protrusion or lump from the vagina. When the prolapse is large, the upper vagina usually descends also and if surgical treatment is undertaken, upper vaginal support/repair is required.
In 2015, sacrospinous colpopexy was introduced to various sites in Bangladesh to treat women with pelvic organ prolapse. Prior to this, only the vaginal hysterectomy and repair without upper vagina support was employed during surgical repairs of prolapse.
Following surgery, women are usually reviewed at 6 weeks, 6 months and 12 months to assess for recurrence of prolapse.
This examination will be done by the local health professionals. If one of the investigators is in Bangladesh during the follow up visit, we will/have examine the woman with the local health professionals. At other times of follow up, the local health professionals will review the women and document the findings in the chart and these charts will be reviewed
Intervention code [1] 300607 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305137 0
Pelvic organ prolapse stage 3 or more on clinical examination at presentation.
The information will be obtained in the medical history/records
Timepoint [1] 305137 0
6 weeks post-surgery, 6 months post-surgery, 12 months post-surgery (primary endpoint)
Secondary outcome [1] 344299 0
symptomatic recurrent pelvic organ prolapse. This will be obtained from patient medical records
Timepoint [1] 344299 0
6 weeks post-surgery, 6 months post surgery

Eligibility
Key inclusion criteria
Who have had pelvic organ prolapse surgery with sacrospinous fixation
Minimum age
30 Years
Maximum age
85 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women who have had prolapse surgery with sacrospinous fixation
Women declining to enter study
Women declining vaginal examination

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/06/2018
Actual
22/06/2018
Date of last participant enrolment
Anticipated
28/06/2019
Actual
1/07/2019
Date of last data collection
Anticipated
26/06/2020
Actual
1/07/2020
Sample size
Target
60
Accrual to date
Final
289
Recruitment outside Australia
Country [1] 9677 0
Bangladesh
State/province [1] 9677 0
Country [2] 9678 0
Nepal
State/province [2] 9678 0

Funding & Sponsors
Funding source category [1] 298953 0
Self funded/Unfunded
Name [1] 298953 0
Country [1] 298953 0
Primary sponsor type
Individual
Name
Prof Judith Goh
Address
Suite 209, Ramsay Specialist Centre
Greenslopes Hospital
Newdegate St
Greenslopes QLD 4120
Country
Australia
Secondary sponsor category [1] 298165 0
Individual
Name [1] 298165 0
Dr Hannah Krause
Address [1] 298165 0
Suite 209, Ramsay Specialist Centre
Greenslopes Hospital
Newdegate St
Greenslopes QLD 4120
Country [1] 298165 0
Australia
Secondary sponsor category [2] 298166 0
Individual
Name [2] 298166 0
Dr Barbara Hall
Address [2] 298166 0
c/o Suite 209, Ramsay Specialist Centre
Greenslopes Private Hospital
Newdegate St
Greenslopes QLD 4120
Country [2] 298166 0
Australia
Secondary sponsor category [3] 298169 0
Individual
Name [3] 298169 0
Ms Anubha Rawat
Address [3] 298169 0
DAK Foundation
48B Egerton St
Silverware NSW 2128
Country [3] 298169 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299889 0
Greenslopes Research and Ethics Committee
Ethics committee address [1] 299889 0
Greenslopes Private Hospital
Newdegate St
Greenslopes QLD 4120
Ethics committee country [1] 299889 0
Australia
Date submitted for ethics approval [1] 299889 0
26/03/2018
Approval date [1] 299889 0
18/04/2018
Ethics approval number [1] 299889 0
Protocol 18/19

Summary
Brief summary
Pelvic organ prolapse is a common problem for women. It presents a lump or bulge extending out from the vagina. About fifty percent of women who have had vaginal childbirth will develop prolapse later in life and in about 20 percent of these women, the prolapse is symptomatic and the woman will seek treatment. Traditionally surgery has been the mainstay of treatment but other options include pelvic floor rehabilitation and the use mechanical devices (pessary).

In 2015, the investigators were approached by to up-skill gynaecologists in the area of vaginal prolapse surgery in low-income countries, in particular, Bangladesh and Nepal. It was brought to the attention of the local gynaecologist that surgeries performed did not provide optimal outcomes and we were approached to provide expert feedback and means to upskill the local gynaecologists.

In 2015, we went to Bangladesh to assess women and surgeries performed. As a result of this, we introduced the concept of vault or upper vagina support during vaginal surgery pelvic reconstructive surgery, that is, the sacrospinous colpopexy procedure. This procedure is commonly performed by gynaecologist, in particular, urogynaecologists in Australia during vaginal prolapse surgery to support the upper vagina. If this is not performed, then the prolapse of the upper vaginal (even after a hysterectomy) is not treated and will prolapse out again.

Since 2015, we have been training the local gynaecologists in a number of locations in Bangladesh and Nepal to perform the sacrospinous colpopexy.

The aim of this study is to review the charts of women who have undergone this surgery to ascertain prolapse recurrence rates. This audit will provide information regarding the main anatomical areas of prolapse recurrence, and hence focus continuing education in these particular areas.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81878 0
Prof Judith Goh
Address 81878 0
Suite 209, Ramsay Specialist Centre
Greenslopes Private Hospital
Newdegate St
Greenslopes QLD 4120
Country 81878 0
Australia
Phone 81878 0
+61 7 38479909
Fax 81878 0
+61 7 38476433
Email 81878 0
[email protected]
Contact person for public queries
Name 81879 0
Prof Judith Goh
Address 81879 0
Suite 209, Ramsay Specialist Centre
Greenslopes Private Hospital
Newdegate St
Greenslopes QLD 4120
Country 81879 0
Australia
Phone 81879 0
+61 7 38479909
Fax 81879 0
+61 7 38476433
Email 81879 0
[email protected]
Contact person for scientific queries
Name 81880 0
Prof Judith Goh
Address 81880 0
Suite 209, Ramsay Specialist Centre
Greenslopes Private Hospital
Newdegate St
Greenslopes QLD 4120
Country 81880 0
Australia
Phone 81880 0
+61 7 38479909
Fax 81880 0
+61 7 38476433
Email 81880 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
patient confidentiality


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes October 2020 doi.org/10.1007/s00912-020-04562-4 374705-(Uploaded-22-02-2021-08-03-57)-Journal results publication.pdf

Documents added automatically
No additional documents have been identified.