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Patient satisfaction after oncoplastic breast surgery


- candidate number28345
- NTR NumberNTR6901
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-dec-2017
- Secondary IDsZ2017135 
- Public TitlePatient satisfaction after oncoplastic breast surgery
- Scientific TitlePatient satisfaction after oncoplastic breast surgery in the context of breast conserving therapy
- ACRONYMTOBO
- hypothesisPatients that receive breast conerserving therapy due to breastcancer with an oncoplastic reconstruction by the plastic surgery are more satisfied with their breast compared to patients receiving breast conserving therapy without a reconstruction.
- Healt Condition(s) or Problem(s) studiedBreast conserving surgery, Breast cancer, Oncoplastic breast surgery
- Inclusion criteria-female - Age of at least 18 years - Patient will undergo a curative breast-conserving surgery due to breast cancer in the affected breast - Mastery of the Dutch language in word and writing. - Informed consent for participation in the research
- Exclusion criteria-Intellectual limitation to such an extent that it can be expected that the interpretation and / or completion of the questionnaires is a problem.
-Previous radiotherapy on the affected chest
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-feb-2018
- planned closingdate1-mei-2019
- Target number of participants110
- Interventions- Patients that receive breast conserserving therapy due to breastcancer with an oncoplastic reconstruction by the plastic surgery
- Patients that receive breast conserving therapy due to breast cancer without a reconstruction.
- Primary outcomesatisfaction of the breast after breast conserving therapy with reconstruction
- Secondary outcomedifference regarding the satisfaction between the 2 groups (with and without reconstruction)
difference regarding the satisfaction between before and after the adjuvant radiotherapy
postoperative complications
- Timepointspreoperative
postoperative, before the adjuvant radiotherapy
postoperative, 3 months after the adjuvant radiotherapy
postoperative, 12 months after the adjuvant radiotherapy
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Nadine Hillberg
- CONTACT for SCIENTIFIC QUERIES Nadine Hillberg
- Sponsor/Initiator Zuyderland Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Zuyderland-Maastro Grant
- Publications
- Brief summaryWe will use the Breast-Q questionaire to investigate the patients' satisfaction concerning her breast after oncoplastic breastreconstruction. We will compare this outcome with the satisfaction of patients that receive a breast conserving surgery without reconstruction.
- Main changes (audit trail)
- RECORD13-dec-2017 - 4-jan-2018


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