The primary objective of this research is external validation of the prediction model that preoperatively estimates the risk of anatomical cystocele recurrence after primary anterior colporrhaphy. The secondary objectives are to identify risk…
ID
Source
Brief title
Condition
- Other condition
- Genitourinary tract disorders NEC
Synonym
Health condition
blaasverzakking
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary goal of this study is external validation of the prediction model
for anatomical recurrence after primary anterior colporrhaphy. The main
endpoint of this study is the calculated area under the curve (AUC) of the
receiving operating curve (ROC).
Secondary outcome
The secundary goal is the identification of other risk factors besides the ones
used in the prediction model for anatomical and subjective recurrence of
cystocele after primary anterior colporrhaphy, calculated by univariate and
multivariate regression analysis.
Background summary
Pelvic organ prolapse (POP) is a common condition. The lifetime risk of surgery
for POP is 13-19%. Cystocele is the most commonly affected compartment of POP.
Anatomical recurrence rates are high after surgery for cystocele (31-59%) and
reoperation is performed frequently. A prediction model that preoperatively
estimates the risk of anatomical cystocele recurrence after anterior
colporrhaphy is developed by Vergeldt et al. This model needs external
validation before it can be used in daily urogynaecological practice.
Study objective
The primary objective of this research is external validation of the prediction
model that preoperatively estimates the risk of anatomical cystocele recurrence
after primary anterior colporrhaphy. The secondary objectives are to identify
risk factors for anatomical and subjective cystocele recurrence in women
treated for cystocele one year after primary colporrhaphy. Risk factors to be
investigated in this study are:
- age at time of surgery
- BMI
- parity and number of vaginal deliveries
- having had an assisted delivery
- preoperative cystocele POPQ stage 3 of 4
- positive family history for POP (mother or sister of the patient with POP)
- number of compartments involved
- simultaneous POP surgery in another compartment at the time of primary
anterior colporrhaphy
- levator ani muscle defect prior to surgery (on 3D ultrasound)
- levator hiatal area prior to surgery (on 3D ultrasound)
Study design
The study will be an observational prospective cohort study, with prospective
follow-up of women treated for cystocele by a primary anterior colporrhaphy in
the participating hospitals.
Study burden and risks
The subjects will not directly benefit from participating in this study. The
results of the study and the validation of the prediction model however will
help to identify patients with a high or low risk of recurrence of POP in the
future. The ultimate goal is to develop a personalised decision aid for
patients who will be treated for POP.
The chance on any adverse event due to participation in the study is close to
zero. The only possible disadvantages of participating in this study are the
possible discomfort of the ultrasound and the gynaecological exam and filling
in the questionnaires and the time this requires.
P. Debeyelaan 25 P. Debeyelaan 25
Maastricht 6229HX
NL
P. Debeyelaan 25 P. Debeyelaan 25
Maastricht 6229HX
NL
Listed location countries
Age
Inclusion criteria
All women who are planned for undergoing a primary anterior colporrhaphy
because of a cystocele (with a POP-Q stage of 2 and higher) in the
participating hospitals who are willing to participate in this study and give
informed consent. Women need to be able to complete the questionnaires. A
combination of a primary anterior colporrhaphy with other POP or incontinence
surgery is permitted.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- < 18 years of age
- Not capable of understanding the Dutch language or other reasons (judged by
the clinician) that make informed consent impossible.
- POP or incontinence surgery prior to index surgery
- The use of mesh or implants during surgery (vaginal or abdominal mesh for POP
surgery, tape for incontinence surgery)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL60381.068.16 |
| OMON | NL-OMON25627 |