Review of sacrospinous fixation surgery for treatment of vaginal prolapse in Bangladesh and Nepal

• Register: ANZCTR
• Last refreshed on: 8 March 2021
• Main ID: ACTRN12618000502235
• Date of registration: 06/04/2018
• Prospective Registration: Yes
• Primary sponsor: Prof Judith Goh
• 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
• Date of first enrolment: 22/06/2018
• Target sample size: 60
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12618000502235.aspx
• Study type: Observational
• Study design: Purpose: Screening;Duration: Longitudinal;Selection: Defined population;Timing: Retrospective;
• Phase: Not Applicable

Countries of recruitment

Bangladesh, Nepal

Contacts

• Name: Prof Judith Goh

• Name: Prof Judith Goh

Key inclusion & exclusion criteria

Inclusion criteria: Who have had pelvic organ prolapse surgery with sacrospinous fixation
Exclusion criteria: Women who have had prolapse surgery with sacrospinous fixation
Women declining to enter study
Women declining vaginal examination

Age minimum: 30 Years
Age maximum: 85 Years
Gender: Females

Health Condition(s) or Problem(s) studied

pelvic organ prolapse;
pelvic organ prolapse

Surgery - Surgical techniques

Reproductive Health and Childbirth - Other reproductive health and childbirth disorders

Intervention(s)

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

Primary Outcome(s)

Pelvic organ prolapse stage 3 or more on clinical examination at presentation.
The information will be obtained in the medical history/records[6 weeks post-surgery, 6 months post-surgery, 12 months post-surgery (primary endpoint)]

Secondary Outcome(s)

symptomatic recurrent pelvic organ prolapse. This will be obtained from patient medical records[6 weeks post-surgery, 6 months post surgery]

Secondary ID(s)

nil known

Secondary Sponsor(s)

Ms Anubha Rawat

Dr Hannah Krause

Dr Barbara Hall

Ethics review

Status: Approved
Approval date: 18/04/2018
Contact:

Greenslopes Research and Ethics Committee

Results

• Results available: Yes
• Date Posted: 02/03/2021
• Date Completed: 01/07/2020