ANZCTR - Registration

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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]

none

Universal Trial Number (UTN)

none

Trial acronym

none

Linked study record

none

Health condition

Health condition(s) or problem(s) studied:

perineal trauma

Condition category

Condition code

Reproductive Health and Childbirth

Other reproductive health and childbirth disorders

Surgery

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Cleveland Clinic anal continence score

Timepoint [1]

6-12 weeks, 12 months, 24 months, 36 months, 48 months, 60 months post-surgery

Secondary outcome [1]

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]

6-12 weeks, 12 months, 24 months,36 months, 48 months, 60 months post-surgery

Secondary outcome [2]

dyspareunia in women who are sexually active.
This will be asked during the follow up telephone call

Timepoint [2]

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?

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]

Uganda

State/province [1]

Country [2]

Tanzania, United Republic Of

State/province [2]

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

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]

Individual

Name [1]

Hannah Krause

Address [1]

Suite 209 Ramsay Specialist Centre
Newdegate Street
Greenslopes Private Hospital
Greenslopes QLD 4120

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Greenslopes Research and Ethics Committee

Ethics committee address [1]

Greenslopes Private Hospital
Newdegate Street
Greenslopes  QLD 4120

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/08/2013

Approval date [1]

10/09/2013

Ethics approval number [1]

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]

/AnzctrAttachments/373861-Ethics GPH Sept2013.pdf (Ethics approval)

Attachments [2]

/AnzctrAttachments/373861-4th degree tear 2016.pdf (Publication)

Contacts

Principal investigator

Name

Prof Judith Goh

Address

Suite 209 Ramsay Specialist Centre
Newdegate Street
Greenslopes Private Hospital
Greenslopes QLD 4120

Country

Australia

Phone

+ 61 7 38479909

Fax

+61 7 38476433

[email protected]

Contact person for public queries

Name

Judith Goh

Address

Suite 209 Ramsay Specialist Centre
Newdegate Street
Greenslopes Private Hospital
Greenslopes QLD 4120

Country

Australia

Phone

+ 61 7 38479909

Fax

+61 7 38476433

[email protected]

Contact person for scientific queries

Name

Judith Goh

Address

Suite 209 Ramsay Specialist Centre
Newdegate Street
Greenslopes Private Hospital
Greenslopes QLD 4120

Country

Australia

Phone

+ 61 7 38479909

Fax

+61 7 38476433

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

patient confidentiality

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
908	Ethical 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

Source	Title	Year of Publication	DOI
Embase	Surgical repair and follow-up of chronic 4th degree obstetric perineal tear (total perineal defect) in 2 centres in eastern Africa.	2021	https://dx.doi.org/10.1007/s00192-021-04841-8

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically