No registrations found.
ID
Source
Brief title
Health condition
Pelvic Organ Prolapse
Recurrence
Prediction model
External validation
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.
Study design
Patients will be analyzed preoperatively and one year postoperatively.
Intervention
Preoperatively, patients will have three dimensional (3D) translabial ultrasound to detect levator defects and to measure the levator hiatus. Also, patients will complete a questionnaire about obstetrical history, family history for POP and the presence
and severity of urogynaecological complaints.
Patients will undergo surgery according to the
daily practice.
One year after surgery, patients will be seen for a follow-up visit in which prolapse quantification will be performed and the same questionnaire will be completed.
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
- < 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
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6292 |
| NTR-old | NTR6466 |
| CCMO | NL60381.068.16 |
| OMON | NL-OMON55841 |