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
| Type | Name | Description |
|---|---|---|
| PROCEDURE | 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. |
| PROCEDURE | Endonasal endoscopic pituitary surgery in supine position | Patients 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.