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The Shrink Study


- candidate number18398
- NTR NumberNTR4692
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-jul-2014
- Secondary IDsMETC13-340 
- Public TitleThe Shrink Study
- Scientific TitleThe Shrink Study - Shrinkage of mucosal margins following resection of Oral Squamous Cell Carcinoma with monopolar electric knife or thulium laser
- ACRONYMThe Shrink Study
- hypothesisWhile head and neck surgeons aim for a 1 cm healthy tissue margin during resection of OSCC, pathological examination often reveals a smaller margin. Our hypothesis is that this occurs due to shrinkage of mucosa following the resection and due to the process of preparation for pathological examination, including formalin fixation, paraffin embedding,
- Healt Condition(s) or Problem(s) studiedHead and Neck Squamous Cell Carcinoma, Oral Squamous Cell Carcinoma (OSCC)
- Inclusion criteria- >18 years old
- Confirmed OSCC stage I IVa (Oncoline, 2004)
- ASA classification I and II
- Exclusion criteria- Previously operated/irradiated OSCC or other malignancy of the oral cavity.
- Stage IVb (inoperable disease)
- Co-morbidities resulting in disability to undergo surgery under general anesthesia
- Inability to sign informed consent
- impaired mental status
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2014
- planned closingdate1-apr-2016
- Target number of participants60
- InterventionsResection using thulium laser or monopolar electric knife
- Primary outcomeTo compare mucosal shrinkage (from in vivo to histopathological examination) in each arm
- Secondary outcome- Shrinkage from in-vivo to directly after resection
- Shrinkage from in-vivo to after formalin fixation
- To define a shrink factor for each resection modality, taking into account the individual energy settings used.
- Timepoints
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. A.J. Pothen
- CONTACT for SCIENTIFIC QUERIESDrs. A.J. Pothen
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
- Publications-
- Brief summary
- Main changes (audit trail)
- RECORD16-jul-2014 - 13-aug-2014


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