To determine the long and short term outcomes of posterior colporrhaphy with and without levator sutures. To compare both groups and maybe give a scientifically proven answer to the question which one has a better outcome. Then we can offer our…
ID
Source
Brief title
Condition
- Other condition
- Obstetric and gynaecological therapeutic procedures
Synonym
Health condition
Bekkenbodem aandoeningen(verzakkingen)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome:
Recurrence rate of posterior wall prolapse
Secondary outcome
Secundary outcomes:
- Short term: postoperative pain (0-10), micturition (+/-), duration of the
surgery, bloodloss and bowel fysfunction (+/-, if so, what type of dysfunction)
- Long term: prolapse symptoms (+/-, PGI-I score), resume daily
activities,(time in weeks) recurrence of prolapse (vaginale examination),
postoperative wound or urinarytract infection (+/-), dyspareunia (+/-)
The data will be gathered by a combination of desk and fieldresearch.
- Deskresearch will be done to determine the shortterm effects. Data research
in the hospitals data system will be performed where surgery reports and
postoperative checks will be included.
- Fieldresearch will be done with interviews where the long term effects will
be determined with a questionairre. This questionairre was formulated in
cooperation with the clinic of psychosomatic gynaecology and sexology of the
LUMC. Patients can decide to take this questionairre at home (digitally or on
paper) or to come to the clinic. In addition to the interviews we will try to
see patients in our clinic to do a physical and vaginal exam, so we can
determine whether or not the is a recurrence of the prolapse.
Background summary
Prolapse of the pelvic organs is a very common problem. 50% of parous women
above 50 have a prolapse of one of the pelvic organs. These prolapses are
mostly asymptomatic. However 11,1% of women with a prolapse experience such
heavy symptoms that surgical correction is indicated. A defect in the posterior
vaginal wall can lead to a rectocele(prolapse of the rectum) or a
enterocele(prolapse of the small bowel). These prolapses can cause symptoms
like difficult defeacation and 'feeling like there is a ball between your
legs'. Surgical correction with a posterior colporrhaphy can relief the
symptoms. During this surgery the defect in the posterior vaginal wall is
corrected. Posterior colporrhaphy reliëfs the symptoms in 86% of all cases.
There are 2 different methods for the posterior colporrhaphy; with or without
certain 'levator sutures'. With these sutures you can create a anterior
plication of the levator ani muscles. The common idea behind this method is
that it should lead to fewer recurrences. However previous research indicates
that this technique may cause more dyspareunia and more bowel dysfunction.
Systematic research to compare both techniques is however lacking. Therefore
there is no golden standard and the surgeons preference determines which method
is chosen.
Therefore we formulated the following research question: Does the use of
levator sutures significantly improve the short and longterm outcomes in
posterior colporrhaphy?
The PICO we formulated is:
P: Patiënts who had posterior colporrhaphy surgery between 01-01-2010 and
31-12-2019 in the Haga hospital in The Hague.
I: Posterior colporrhaphy with levator sutures
C: Posterior colporrhaphy without levator sutures
O: Short term: postoperative pain, micturition and bowel dysfunction
Long term: resume daily activities, recurrence rate of prolapse,
postoperative wound or urinarytract infection, dyspareunia
Study objective
To determine the long and short term outcomes of posterior colporrhaphy with
and without levator sutures. To compare both groups and maybe give a
scientifically proven answer to the question which one has a better outcome.
Then we can offer our patients the best treatment and patient care.
Study design
It is a observational study in the form of a retrospective cohort study.
Prospective randomised research is ideal, however that takes up a lot opf time.
Therefore we chose a retrospective design to compare both groups and to see if
further prospective research is necessary and indicated.
Study burden and risks
Patients can choose the extent of the burden they put themselves under.
- Data research can be done without the help of the patients, they don't have
to do anything.
- Interviews; the patient can choose whether or not to cooperate with the
study. If they do; the interviews will be about 10 minutes long and patients
can answer the questions from home or come to the clinic to take the
questionairre.
- Physical examination in the clinic: the appointment will be about 20 minutes
long, people have to travel to the appointment and they will get a physical and
vaginal exam. Which can cause discomfort or sometimes some pain. During this
exam we can possibly observe a recurrence of the prolapse or other
abnormalities for which we may want to do further research or suggest a
treatment.
Els Borst-Eilersplein 275
Den Haag 2545AA
NL
Els Borst-Eilersplein 275
Den Haag 2545AA
NL
Listed location countries
Age
Inclusion criteria
Patients who had posterior colporrhaphy surgery between 01-01-2010 and
31-12-2019 in the Haga hospital in The Hague.
Exclusion criteria
- Patients whose contact info are outdated
- Patients who don't want to participate in the research(they are excluded for
the interviews, not the data research)
- Patients where postoperative data is missing
- Patients where it is unclear which operation method was used
Design
Recruitment
metc-ldd@lumc.nl
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 | NL73134.058.20 |