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Studie naar hysteroscopische behandeling van littekendefecten na sectio bij patienten met abnormaal uterien bloedverlies.


- candidate number6133
- NTR NumberNTR1922
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-jul-2009
- Secondary IDsNL28897.100.09 VCMO
- Public TitleStudie naar hysteroscopische behandeling van littekendefecten na sectio bij patienten met abnormaal uterien bloedverlies.
- Scientific TitleHystreoscopic treatment of cesarean scar defect in patients with abnormal uterine bleeding.
- ACRONYMHysPAS
- hypothesisIs resection of cesarean scar tissue in patients with a cesarean scar defect and abnormal bleeding a safe and effective treatment.
- Healt Condition(s) or Problem(s) studiedHysteroscopy, Abnormal uterine bleeding, Cesarean scar defect
- Inclusion criteriaPatients with a cesarean scar defect and abnormal uterine bleeding.
- Exclusion criteria1. Pregnancy;
2. Wish for pregnancy in future;
3. Other gynaecological problems (myoma, polyps).
- mec approval receivedno
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 9-jan-2009
- planned closingdate3-jan-2010
- Target number of participants22
- InterventionsHysteroscopic resection of cesarean scar tissue in uterus/cervix.
- Primary outcomeDecrease in days of bloodloss/spotting (pictorial chart).
- Secondary outcome1. Quality of life by SF -36 questionaire;
2. Complications;
3. Decrease in dysmenorrhoe by VAS score;
4. Satisfaction patients with therapy by questionaire.
- TimepointsQuestionaire at inclusion, 3 en 12 months post operative.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES L.F. Voet, van der
- CONTACT for SCIENTIFIC QUERIES L.F. Voet, van der
- Sponsor/Initiator Ziekenhuis Deventer Department of gynaecology, Sint Antonius Ziekenhuis Nieuwegein , Department of gynaecology , VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Stichting Nieuwegein
- PublicationsN/A
- Brief summaryThere is a association between uterine bleeding disorders and a cesarean scar defect. Patients with abnormal uterine bleeding and a cesarean scar defect in the uterus (seen by contrast sonohysterography) will undergo a hysteroscopic resection of the scarred tissue. Primairy outcome is decrease of days of abnormal bleeding. Secundairy outcome are patients satisfaction, quality of live and decrease of dysmenorrhoe. Also the safety of the procedure will be investigated. Patients fullfill a questionaire and a pictorial chart of their menstruation before operation and 3 and 12 months post operative. And will have a contrast sonohysterography before operation and 3 moths post operative.
- Main changes (audit trail)
- RECORD23-jul-2009 - 10-okt-2009


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