Clinical Trials Directory

Trials / Completed

CompletedNCT04584866

Semi-sitting Versus Supine Position in Endoscopic Skull Base Surgery

Semi-sitting Versus Supine Position in Endoscopic Skull Base Surgery (PosESS-Study) - Study Protocol for a Randomized-controlled Single-blinded Superiority Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
54 (actual)
Sponsor
University Hospital, Basel, Switzerland · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREEndonasal endoscopic pituitary surgery in semi-sitting positionPatients 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.
PROCEDUREEndonasal endoscopic pituitary surgery in supine positionPatients will be operated in the standard supine neutral position

Timeline

Start date
2021-01-22
Primary completion
2024-06-29
Completion
2024-06-29
First posted
2020-10-14
Last updated
2025-04-29

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT04584866. Inclusion in this directory is not an endorsement.