Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001520325
Ethics application status
Approved
Date submitted
23/10/2017
Date registered
31/10/2017
Date last updated
11/11/2020
Date data sharing statement initially provided
8/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Follow up of outcomes after surgical repair of chronic severe childbirth perineal tears
Scientific title
Audit of clinical outcomes following repair of chronic 3rd and 4th degree perineal tears in women attending surgical camps in Africa
Secondary ID [1] 293186 0
none
Universal Trial Number (UTN)
none
Trial acronym
none
Linked study record
none

Health condition
Health condition(s) or problem(s) studied:
perineal trauma 305182 0
Condition category
Condition code
Reproductive Health and Childbirth 304498 304498 0 0
Other reproductive health and childbirth disorders
Surgery 304520 304520 0 0
Surgical techniques

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Women attending surgical camps in Africa, with unrepaired 3rd and 4th degree perineal tears will be invited to participate in the follow up.
All women will have a routine history and examination, including a Cleveland Clinic anal continence score(collected prospectively).
All women who are fit for surgery will be offered surgery, performed under spinal anaesthesia. The repair is undertaken by mobilisation of the vaginal and anorectal tissues. The anorectal mucosa is closed in 2 layers using a delayed absorbable suture, then an over-lapping external anal sphincter repair is undertaken. The perineal body is reconstructed and vaginal epithelium and perineal body skin closed. An indwelling bladder catheter and vaginal are inserted and both are removed day 2 post-operatively. Routine post-operative observations and analgesics are given.
After discharge from hospital, women consenting to follow up will be contacted by telephone by the local nurse, speaking in the local language. The Cleveland Clinic score is documented at 6-12 weeks following surgery, and at yearly intervals for a period of 5-years. The local nurse contacts the women at those time intervals to prospectively collect the score.
Intervention code [1] 299439 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303735 0
Cleveland Clinic anal continence score
Timepoint [1] 303735 0
6-12 weeks, 12 months, 24 months, 36 months, 48 months, 60 months post-surgery
Secondary outcome [1] 339998 0
sexual activity - the women will be asked if they are sexually active during the telephone interview (whilst Cleveland Clinic Continence Score is also undertaken)
Timepoint [1] 339998 0
6-12 weeks, 12 months, 24 months,36 months, 48 months, 60 months post-surgery
Secondary outcome [2] 340095 0
dyspareunia in women who are sexually active.
This will be asked during the follow up telephone call
Timepoint [2] 340095 0
6-12 weeks, 12 months, 24 months, 36 months, 48 months, 60 months post operatively

Eligibility
Key inclusion criteria
Women attending surgical camps with unreported 3rd or 4th degree perineal tears
Minimum age
12 Years
Maximum age
85 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women who decline follow-up after surgery

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
Cleveland Clinic scores will be compared pre-operatively and at each of the time points for follow up

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
18/12/2013
Date of last participant enrolment
Anticipated
30/12/2022
Actual
Date of last data collection
Anticipated
1/01/2025
Actual
Sample size
Target
150
Accrual to date
120
Final
Recruitment outside Australia
Country [1] 9308 0
Uganda
State/province [1] 9308 0
Country [2] 9312 0
Tanzania, United Republic Of
State/province [2] 9312 0

Funding & Sponsors
Funding source category [1] 297813 0
Self funded/Unfunded
Name [1] 297813 0
Country [1] 297813 0
Primary sponsor type
Individual
Name
Judith Goh
Address
Suite 209
Ramsay Specialist Centre
Newdegate Street
Greenslopes Private Hospital
Greenslopes QLD 4120
Country
Australia
Secondary sponsor category [1] 296856 0
Individual
Name [1] 296856 0
Hannah Krause
Address [1] 296856 0
Suite 209 Ramsay Specialist Centre
Newdegate Street
Greenslopes Private Hospital
Greenslopes QLD 4120
Country [1] 296856 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298870 0
Greenslopes Research and Ethics Committee
Ethics committee address [1] 298870 0
Greenslopes Private Hospital
Newdegate Street
Greenslopes QLD 4120
Ethics committee country [1] 298870 0
Australia
Date submitted for ethics approval [1] 298870 0
28/08/2013
Approval date [1] 298870 0
10/09/2013
Ethics approval number [1] 298870 0
Protocol 13/46

Summary
Brief summary
1-4% of women worldwide have vaginal deliveries which result in 3rd/4th degree perineal tears. A 3rd/4th degree tear means that the perineal tear extends through the anal sphincter and into the rectum. The result if unrepaired is faecal incontinence. Ideally if a woman suffers this injury during childbirth, the injury should be repaired immediately. In resource poor countries like Uganda, many women do not have access to obstetric care and thus these injuries are not repaired. This results in ongoing faecal incontinence.
The investigators have been performing surgeries to repair these chronic 3rd/4th degree tears in Uganda since 2010. This is a follow-up audit of surgery performed.
There is minimal published data on outcomes of repair of chronic 3rd/4th degree perineal tears. This project aims to follow-up women who have had this injury repaired by the investigating team, to assess for any ongoing anorectal symptoms eg faecal incontinence.
Trial website
Not applicable
Trial related presentations / publications
Goh JTW, Tan SBM, Natukunda H, Singasi I, Krause HG. Outcomes following surgical repair using layered closure of unrepaired 4th degree perineal tear in rural western Uganda. Int Urogynecol J 2016; 27(11), 1661-1666. DOI 10.1007/s00192-016-3024-6
Public notes
Attachments [1] 2139 2139 0 0
/AnzctrAttachments/373861-Ethics GPH Sept2013.pdf (Ethics approval)
Attachments [2] 2140 2140 0 0
/AnzctrAttachments/373861-4th degree tear 2016.pdf (Publication)

Contacts
Principal investigator
Name 78502 0
Prof Judith Goh
Address 78502 0
Suite 209 Ramsay Specialist Centre
Newdegate Street
Greenslopes Private Hospital
Greenslopes QLD 4120
Country 78502 0
Australia
Phone 78502 0
+ 61 7 38479909
Fax 78502 0
+61 7 38476433
Email 78502 0
[email protected]
Contact person for public queries
Name 78503 0
Prof Judith Goh
Address 78503 0
Suite 209 Ramsay Specialist Centre
Newdegate Street
Greenslopes Private Hospital
Greenslopes QLD 4120
Country 78503 0
Australia
Phone 78503 0
+ 61 7 38479909
Fax 78503 0
+61 7 38476433
Email 78503 0
[email protected]
Contact person for scientific queries
Name 78504 0
Prof Judith Goh
Address 78504 0
Suite 209 Ramsay Specialist Centre
Newdegate Street
Greenslopes Private Hospital
Greenslopes QLD 4120
Country 78504 0
Australia
Phone 78504 0
+ 61 7 38479909
Fax 78504 0
+61 7 38476433
Email 78504 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
908Ethical approval    373861-(Uploaded-28-12-2018-11-48-35)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseSurgical repair and follow-up of chronic 4th degree obstetric perineal tear (total perineal defect) in 2 centres in eastern Africa.2021https://dx.doi.org/10.1007/s00192-021-04841-8
N.B. These documents automatically identified may not have been verified by the study sponsor.