Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-26 @ 2:33 PM
Study NCT ID:
NCT04584866
Status:
COMPLETED
Last Update Posted:
2025-04-29
First Post:
2020-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Semi-sitting Versus Supine Position in Endoscopic Skull Base Surgery
Sponsor:
University Hospital, Basel, Switzerland
Organization:
Study Overview
Official Title:
Semi-sitting Versus Supine Position in Endoscopic Skull Base Surgery (PosESS-Study) - Study Protocol for a Randomized-controlled Single-blinded Superiority Trial
Status:
COMPLETED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PosESS
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: