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The external validation of a prediction model for anatomical cystocele recurrence after primary anterior colporrhaphy


- candidate number27315
- NTR NumberNTR6466
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-mei-2017
- Secondary IDsNL60381.068.16 
- Public TitleThe external validation of a prediction model for anatomical cystocele recurrence after primary anterior colporrhaphy
- Scientific TitleThe external validation of a prediction model for anatomical cystocele recurrence after primary anterior colporrhaphy
- ACRONYMPARCC study
- hypothesis
- Healt Condition(s) or Problem(s) studiedRelapse, Prolapse, Prediction model
- Inclusion criteriaAll 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)
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 23-mei-2017
- planned closingdate1-mei-2020
- Target number of participants250
- InterventionsPreoperatively, 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.
- Primary outcomeThe 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 outcomeThe 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.
- TimepointsPatients will be analyzed preoperatively and one year postoperatively.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. I.M.H. Kessels
- CONTACT for SCIENTIFIC QUERIESDrs. I.M.H. Kessels
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
Self Funding
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD25-mei-2017 - 3-jul-2017


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl