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Hysteroscopic resection of uterine caesarean scar defect (niche) in patients with abnormal bleeding, a randomized controlled trial


- candidate number11071
- NTR NumberNTR3269
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-feb-2012
- Secondary IDs2011/397  VUMC Amsterdam
- Public TitleHysteroscopic resection of uterine caesarean scar defect (niche) in patients with abnormal bleeding, a randomized controlled trial
- Scientific TitleHysteroscopic resection of uterine caesarean scar defect (niche) in patients with abnormal bleeding, a randomized controlled trial
- ACRONYMHysNiche
- hypothesisThe primary hypothesis is that hysteroscopic resection of the niche will reduce post-menstrual spotting with 3 days.
- Healt Condition(s) or Problem(s) studiedNiche, Caesarean section, Abnormal uterine bleeding, Uterine rupture, Hysteroscopic resection
- Inclusion criteria1. Post menstrual spotting;
2. Niche with residual myometrium> 3mm and depth size > 2mm.
- Exclusion criteria1. Pregnancy;
2. Age below 18 years;
3. Other disorders that may induce spotting;
4. Contra-indications for spinal or general anesthesia.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2012
- planned closingdate1-dec-2015
- Target number of participants100
- Interventions1. Hysteroscopic Nicheresection;
2. Expectative, conservative policy.
- Primary outcomePost menstrual spotting.
- Secondary outcome1. Quality of life;
2. Bleeding specific questionnaire;
3. Sexual function score;
4. VAS score;
5. Cost-effectiveness analysis;
6. Pregnancy outcome.
- Timepoints1. Baseline: Previous medical history, menstrual card;
2. 3, 12 months: Quality of life, cost-effectiveness analysis.
- Trial web sitehttp://www.studies-obsgyn.nl/hysniche
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. A.J.M.W. Vervoort
- CONTACT for SCIENTIFIC QUERIESMD. PhD. J.A.F. Huirne
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryIn western countries, caesarean rates are rising. A caesarean section can cause a niche (defect at the site of the uterine scar).The incidence of niche related postmenstrual spotting in the Netherlands is expected to be 4100 per year. Promising results are reported after an innovative minimally invasive hysteroscopic resection of these niches. However its (cost) effectiveness in comparison to a control group has to be proven. Our primary objective is to study the effectiveness of hysteroscopic resection for niche related uterine bleeding disorders. Our secondary objective is to asses the quality of life, sexual function and cost-effective analysis will be made. The study is a multicentre randomized controlled trial. Patients will be randomly allocated to hysteroscopic resection or expectant management. Randomization will be performed centrally with the use of a permuted block design, stratified for recruiting centre. Women with post-menstrual uterine spotting and a niche with sufficient residual myometrium (at least 3mm) without any other intra-uterine disorders. Measurement with questionnaires will be performed at baseline, three and six months after randomization (control) or surgery (intervention). Cost-effectivity will be analysed at 12 months after randomization. Niche features will be measured by sonography at the baseline and after 3 months in both groups. At baseline a hysterosonography will be performed in all women to measure the niche and evaluate possible other causes of spotting in normal diagnostic workup. Prognostic dissimilarities will be registered, like previous therapies.
- Main changes (audit trail)25-nov-2014: Changes:
- Primary outcome changed into: "Postmenstrual spotting 6 months after randomization"
- Removal of secondary outcome 6.
- Updated summary
[AB]
- RECORD1-feb-2012 - 25-nov-2014


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