Follow up of outcomes after surgical repair of chronic severe childbirth perineal tears

• Register: ANZCTR
• Last refreshed on: 16 November 2020
• Main ID: ACTRN12617001520325
• Date of registration: 31/10/2017
• Prospective Registration: No
• Primary sponsor: Judith Goh
• 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
• Date of first enrolment: 18/12/2013
• Target sample size: 150
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12617001520325.aspx
• Study type: Observational
• Phase: Not Applicable

Countries of recruitment

Tanzania, United Republic Of, Uganda

Contacts

• Name: Prof Judith Goh

• Name: Prof Judith Goh

Key inclusion & exclusion criteria

Inclusion criteria: Women attending surgical camps with unreported 3rd or 4th degree perineal tears
Exclusion criteria: Women who decline follow-up after surgery


Age minimum: 12 Years
Age maximum: 85 Years
Gender: Females

Health Condition(s) or Problem(s) studied

perineal trauma;
perineal trauma

Reproductive Health and Childbirth - Other reproductive health and childbirth disorders

Surgery - Surgical techniques

Intervention(s)

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.

Primary Outcome(s)

Cleveland Clinic anal continence score[6-12 weeks, 12 months, 24 months, 36 months, 48 months, 60 months post-surgery]

Secondary Outcome(s)

dyspareunia in women who are sexually active.
This will be asked during the follow up telephone call[6-12 weeks, 12 months, 24 months, 36 months, 48 months, 60 months post operatively]

sexual activity - the women will be asked if they are sexually active during the telephone interview (whilst Cleveland Clinic Continence Score is also undertaken)[6-12 weeks, 12 months, 24 months,36 months, 48 months, 60 months post-surgery]

Secondary ID(s)

none

Secondary Sponsor(s)

Hannah Krause

Ethics review

Status: Approved
Approval date: 10/09/2013
Contact:

Greenslopes Research and Ethics Committee