Clinical trial NCT04584866: Semi-sitting Versus Supine Position in Endoscopic Skull Base Surgery
Official title: Semi-sitting Versus Supine Position in Endoscopic Skull Base Surgery (PosESS-Study) - Study Protocol for a Randomized-controlled Single-blinded Superiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pituitary Adenoma
Keywords: endoscopic endonasal pituitary surgery
endoscopic skull base surgery
intracranial venous pressure
venous air embolism
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective randomized single-blinded controlled superiority trial
Primary purpose: TREATMENT

Brief summary: This study is to prospectively compare the standard supine (control group) and the semi-sitting position (head elevation of 30°; intervention group) in endoscopic endonasal pituitary surgery.

Detailed description: The endonasal endoscopic approach (EEA) for pituitary surgery is standardly performed with the patient in supine position (SP). The semi-sitting position (SSP) is routinely used for the traditional microscopic transsphenoidal approach and also for posterior fossa surgery. The SSP results in lower intracranial pressure when compared to the supine position due to decreased venous congestion. As a result, intraoperative bleeding may be reduced, potentially leading to decreased surgical morbidity and improved surgical workflow. Studies during endoscopic sinus surgery have shown a significant reduction of blood loss when the patient is placed in a reverse Trendelenburg position with a head elevation of 30°. This study is to prospectively compare the standard supine (control group) and the semi-sitting position (head elevation of 30°; intervention group) in endoscopic endonasal pituitary surgery.

Eligibility criteria: Inclusion Criteria:

* Patients with a presumed pituitary pathologies who are suitable for endoscopic endonasal surgical resection

Exclusion Criteria:

* Patients with known hemorrhagic or thrombophilic disorders
* Patients with conditions associated with high central venous pressure: congestive heart failure, pulmonary hypertension, chronic obstructive pulmonary disease (COPD), interstitial lung disease, pregnancy
* Patients with poor cardiopulmonary condition (unable to perform 4 metabolic equivalents without stopping (climb a flight of stairs))

Primary outcomes:
measure: Intraoperative blood loss
timeFrame: Intraoperative
measure: Frequency of interruption of the surgical workflow due to disturbing blood or a bleeding in the surgical field (number)
timeFrame: During surgery
Secondary outcomes:
measure: Change in intraoperative Mean Arterial Pressure (MAP)
timeFrame: Intraoperative
measure: Amount of intravenous fluid administered during surgery (ml)
timeFrame: Intraoperative
measure: Need for vasoactive drugs (vasopressors) (number)
timeFrame: at Day 1 (day of surgery)
measure: Incidence of air embolism (number)
timeFrame: at Day 1 (day of surgery)
measure: Operative time (minutes)
timeFrame: During surgery
measure: Degree of descent or prolapse of the diaphragma sellae into the sellar cavity
timeFrame: Intraoperative
measure: Occurrence of a cerebrospinal fluid (CSF) leak during surgery (assessed by the operating neurosurgeon) (yes/ no)
timeFrame: During surgery
measure: Surgical ergonomics
timeFrame: at Day 1 (day of surgery)
measure: Incidence of rhinoliquorrhoea (number)
timeFrame: at 3 months after surgery
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Neurosurgery, University Hospital Basel
Study officials:
affiliation: Department of Neurosurgery, University Hospital Basel
name: Jonathan Rychen
role: PRINCIPAL_INVESTIGATOR
References: