Jonathan Rychen Principal Investigator Department of Neurosurgery, University Hospital Basel
Kontakt
Jonathan Rychen, Dr. med. Kontakt: Phone: +41 61 328 51 84 E-Mail: Jonathan.Rychen@usb.ch» Kontaktdaten anzeigen Michel Röthlisberger, Dr. med. Kontakt: Phone: +41 61 328 54 48 E-Mail: Michel.Roethlisberger@usb.ch» Kontaktdaten anzeigen
Studienlocations (1 von 1)
Department of Neurosurgery, University Hospital Basel 4031 Basel SwitzerlandRekrutierend» Google-Maps Ansprechpartner: Jonathan Rychen, Dr. med. Phone: +41 61 328 51 84 E-Mail: Jonathan.Rychen@usb.ch
Michel Roethlisberger, Dr. med. Phone: +41 61 328 54 48 E-Mail: Michel.Roethlisberger@usb.ch» Ansprechpartner anzeigen
1. Intraoperative blood loss (Time Frame - Intraoperative): Intraoperative blood loss, calculated as follow: volume in the suction bag minus volume of rinsing water in Milliliters (ml). The surgery is divided into four steps: 1. endonasal phase, 2. osteodural exposure. 3. sellar stage and 4. skull base defect closure. For each step, the primary outcome will be assessed.
2. Frequency of interruption of the surgical workflow due to disturbing blood or a bleeding in the surgical field (number) (Time Frame - During surgery): Frequency of interruption of the surgical workflow due to disturbing blood or a bleeding in the surgical field. This will be assessed by an independent blinded neurosurgeon, who will watch the operative video after the surgery.
2. Amount of intravenous fluid administered during surgery (ml) (Time Frame - Intraoperative): Amount of intravenous fluid administered during surgery (ml)
3. Need for vasoactive drugs (vasopressors) (number) (Time Frame - at Day 1 (day of surgery)): Need for vasoactive drugs (vasopressors) (number)
4. Incidence of air embolism (number) (Time Frame - at Day 1 (day of surgery)): Incidence of air embolism (number)
5. Operative time (minutes) (Time Frame - During surgery): Operative time (minutes)
6. Degree of descent or prolapse of the diaphragma sellae into the sellar cavity (Time Frame - Intraoperative): Intraoperative assessment of the degree of descent or prolapse of the diaphragma sellae into the sellar cavity (class I to V, according to the classification of Abdelmaksoud et al)
7. Occurrence of a cerebrospinal fluid (CSF) leak during surgery (assessed by the operating neurosurgeon) (yes/ no) (Time Frame - During surgery): Occurrence of a cerebrospinal fluid (CSF) leak during surgery (assessed by the operating neurosurgeon)
8. Surgical ergonomics (Time Frame - at Day 1 (day of surgery)): Surgical ergonomics assessed by the means of a standardized questionnaire. The surgeon will be asked to rate the intensity of neck and arm discomfort and the frequency of surgical flow interruption due to a suboptimal trajectory of the endoscope and the instruments due to the patient Position (1 = no discomfort, 2 = medium discomfort, 3 = high discomfort).
9. Incidence of rhinoliquorrhoea (number) (Time Frame - at 3 months after surgery): Incidence of rhinoliquorrhoea (number)
Endonasal endoscopic pituitary surgery in semi-sitting position: Patients will be placed in semi-sitting position. To achieve the semi-sitting position, the patient is placed in supine position. The operating table is then separated and flexed to elevate the torso (angle of 30°). The head, which is fixed in a head clamp, is slightly flexed to bring the floor of the sella right in front of the surgeon and gently rotated toward the operating team.
Endonasal endoscopic pituitary surgery in supine position: Patients will be operated in the standard supine neutral position
Quelle: ClinicalTrials.gov
Sie können folgenden Inhalt einem Kollegen empfehlen:
"Semi-sitting Versus Supine Position in Endoscopic Skull Base Surgery"
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