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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR1866 |
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Date of registration:
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18/06/2009 |
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Primary sponsor: |
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Public title:
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SAVE U -trial: Sacrospinous fixation versus vaginal hysterectomy in treatment of a uterine prolapse stage ≥ 2: a multi-center randomised controlled trial.
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Scientific title:
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Sacrospinous fixation versus vaginal hysterectomy in treatment of a uterine prolapse stage ≥ 2: a multi-center randomised controlled trial.
- SAVE U |
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Date of first enrolment:
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1/8/2009 |
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Target sample size:
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208 |
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Recruitment status: |
pending |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1866 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: None; Control: Active; Group: Parallel; Type: 2 or more arms, randomized
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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R.J.
Detollenaere |
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Address:
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Postbus 10400, Isala Klinieken afdeling Obstetrie en gynaecologie
8000 GK
Zwolle
The Netherlands |
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Telephone:
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+31 (0)38 424 7415 |
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Email:
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r.j.detollenaere@isala.nl |
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Affiliation:
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Name:
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R.J.
Detollenaere |
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Address:
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Postbus 10400, Isala Klinieken afdeling Obstetrie en gynaecologie
8000 GK
Zwolle
The Netherlands |
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Telephone:
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+31 (0)38 424 7415 |
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Email:
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r.j.detollenaere@isala.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: POP-Q stage ≥ 2 uterine descent requiring surgery. Patients with co-existing anterior / posterior defects or concomitant incontinence surgery (TVT-O) can be included
too.
Exclusion criteria: 1. Previous pelvic floor or prolapse surgery;
2. Known malignancy or abnormal cervical smears;
3. Wish to preserve fertility;
4. Unwilling to return for follow-up or language barriers;
5. Presence of immunological / haematological disorders interfering with recovery after surgery;
6. Abnormal ultrasound findings of uterus or ovaries, or abnormal uterine bleeding.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Hysterectomy, Uterine descent, Sacrospinous fixation
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Intervention(s)
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Random allocation to sacrospinous fixation or vaginal hysterectomy.
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Primary Outcome(s)
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Primary outcome: anatomical outcome and recurrence rate assessed by a POP-Q-test at one year follow-up.
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Secondary Outcome(s)
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Secondary outcomes are subjective improvement on urogenital symptoms and quality of life (assessed by disease-specific and quality of life questionnaires), complications following surgery, hospital stay, post-operative recovery and sexual functioning.
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Secondary ID(s)
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METC 09.0652
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Source(s) of Monetary Support
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Isala Klinieken
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