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Main
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Note: This record shows only 22 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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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00013348 |
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Date of registration:
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23/11/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The influence of patient positioning on intraoperative blood loss in orthognathic surgery - a randomised controlled trial
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Scientific title:
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The influence of patient positioning on intraoperative blood loss in orthognathic surgery - a randomised controlled trial |
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Date of first enrolment:
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31/01/2018 |
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Target sample size:
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80 |
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Recruitment status: |
Recruiting |
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URL:
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http://drks.de/search/en/trial/DRKS00013348 |
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Study type:
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interventional |
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Study design:
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Allocation: Randomized controlled study; Masking: Open (masking not used); Control: active; Assignment: parallel; Study design purpose: treatment
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Phase:
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N/A
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Countries of recruitment
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Austria
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Contacts
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Name:
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Jens
Meier |
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Address:
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Krankenhausstraße 9
4020
Linz
Austria |
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Telephone:
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004357680832158 |
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Email:
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jens.meier@kepleruniklinikum.at |
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Affiliation:
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Klinik für Anästhesiologie und Intensivmedizin, Med Campus III, Kepler Universitätsklinikum Linz |
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Name:
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Raphael
Stehrer |
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Address:
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Krankenhausstraße 9
4020
Linz
Austria |
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Telephone:
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004357680832124 |
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Email:
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raphael.stehrer@kepleruniklinikum.at |
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Affiliation:
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Klinik für Mund-, Kiefer- und Gesichtschirurgie, Med Campus III, Kepler Universitätsklinikum Linz |
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients aged 14 to 90 presented to the Department of Oral and Maxillofacial Surgery at the Kepler University Hospital for whom a bignathe surgical remodeling osteotomy is induced due to malocclusion (bilateral sagittal split osteotomy in combination with a Le-Fort 1 osteotomy).
Exclusion criteria: Patients with genetic syndromal anomalies, patients with congenital or acquired haemorrhagic diathesis (abnormally increased tendency to bleed), patients with vascular malformations in the neck / head area, revision surgery and previously operated patients (e.g. patients with orofacial cleft)
Age minimum:
14 Years
Age maximum:
90 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Dentofacial anomalies [including malocclusion]
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K07
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Intervention(s)
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Group 1: Bilateral sagittal split osteotomy in combination with a Le-Fort 1 osteotomy: surgery in flat position (0 degree)
Group 2: Bilateral sagittal split osteotomy in combination with a Le-Fort 1 osteotomy: surgery in 15 degree reverse Trendelenburg position
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Primary Outcome(s)
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Intraoperative Blood loss: After the operation, the weighing of the required wipes, the measurement of the rinsing liquid and the liquid in the surgical aspirator aswell as the filling of the corresponding attached protocol are carried out by the surgeon and the assistant nurse. Thus, the intraoperative blood loss can be determined as the main target and statistically checked whether there is a significant difference between the two groups.
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Secondary Outcome(s)
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Duration of surgery, length of hospital stay, preoperative laboratory, anesthesiological parameters, transfused volume of erythrocytes, subjective visualization of the operating area by the surgeon, subjective intraoperative blood loss by surgeon
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Secondary ID(s)
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U1111-1205-2178
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Source(s) of Monetary Support
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Klinik für Anästhesiologie und IntensivmedizinMed Campus IIIKepler Universitätsklinikum Linz
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Ethics review
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Status: Approved
Approval date: 02/11/2017
Contact:
Kepler Universitätsklinikum GmbHEthikkommission des Landes Oberösterreich [Ethikkommission des Landes Oberösterreich]
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