- to establish the long-term alteration of anorectal function in women after promary repair of a third degree obstetrical anal sphincter rupture- to evalute the following complaints in women in late postpartum period after 3rd degree rupture:…
ID
Source
Brief title
Condition
- Anal and rectal conditions NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
a) Changes of anorectal function assessed by anal manometry, rectal compliance
measurement and anal endosonography
b) Clinical symptoms:
o faecal symptoms measured by Vaizey and Wexner scores:
o urinary incontinence (urge/ stress/ mixed) measured by ICIQ-SF
o sexual complaints measured by BIQ, PSHQ, MMQ, FSDS, FSFI, SPEQ
Secondary outcome
- quality of life measured by QLQ-FS 36
Background summary
Third-degree obstretric tear is a vaginal tear with clinical disruption of the
perineum with total separation of the anal sphincters, with or without a breach
of the anal epithelium. In the literature, the incidence of third degree
rupture is reported between 0.6-6%.
Faecal incontinence is a frequent problem after childbirth. This can be due to
damage of the anal sphincter (third degree rupture) or stretch injury of
pudendal nerve. Often these two factors both play a role. After delivery, some
improvement can be expected in the first months. This is due to partial
recovery from the overstretching of the muscles in the pelvic floor and of the
pudendal nerve. However, many women will develop complains of faecal
incontinence later in life, attributed to aging or subsequent deliveries with
nerve damage or sphincter atrophy.
The literature about the incidence of faecal incontinence is not clear.
Furthermore, awareness of the importance of a good sphincter repair postpartum
has increased and is performed in the operative room and not in the obstetric
ward.
Sexual complaints are associated with anal sphincter injury as well and it
seems that the complaints become even more severe two decades after delivery.
However, other study with the same follow-up time of 18 to 20 years, found no
significant association of anal sphincter injury with sexual complaints.
In summary, studies have shown that a third degree rupture may lead to
incontinence and sexual complaints and warrant increase attention because the
complaints are hidden by patients.
Most of the studies with a long term follow-up were only based on
questionnaires and no anal function tests were performed. Long-term follow-up
of such women will be necessary to determine whether they are at risk for
incontinence and sexual complains later in life.
Study objective
- to establish the long-term alteration of anorectal function in women after
promary repair of a third degree obstetrical anal sphincter rupture
- to evalute the following complaints in women in late postpartum period after
3rd degree rupture:
faecal incontinence
sexual complaints
urinary incontinence
- to relate the anal endosonography and anorectal manometry findings with the
clinical outcome
Study design
Since 1998, 71 patients who experienced a 3rd degree anal sphincter rupture in
our department of Obstetrics were seen for anorectal function evaluation in our
department of Gastroenterology. After a 3rd degree anal sphincter rupture, all
women had an overlapping sphincter repair under general anaesthesia in the
operation room. Anal manometry and anal endosonography were performed 3 to 4
months after their delivery.
During their referral, all patients were already informed that they might be
contacted in the future for follow-up and all agreed. Their addresses are
retrieved from the electronic patient files. If women have moved from the last
known address, the current address will be traced with the help of the family
doctor.
All patients will be asked to fill in questionnaires regarding anorectal
complaints, urinary symptoms and sexual function. Furthermore, they will be
invited to undergo anorectal function tests again. The actual complaints and
the results of present anorectal function tests will be compared with the
results of the anorectal function test of the last referral.
Study burden and risks
No specific ethical problems exist. The anorectal examinations are easy to
perform and well tolerated by patients. It requires no bowel preparation. The
investigation takes only a few minutes. The use of hydrogen can be considered
as a safe, economic and accurate procedure to assess fistulas. Furthermore, all
patients were already informed that they might be contacted in the future for
follow up and all agreed. In addition, all patients had these test previously.
De Boelelaan 1118
1081 HZ Amsterdam
Nederland
De Boelelaan 1118
1081 HZ Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
-Diagnosis of 3rd degree anal sphincter rupture confirmed by gynaecologist during repair
-Evaluation of anorectal function 3-4 months after 3rd degree anal sphincter rupture
Exclusion criteria
females who had a delivery < 6 months
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL28159.029.09 |