Semi-sitting Versus Supine Position in Endoscopic Skull Base Surgery (PosESS)

University Hospital Basel

Status: Enrolling

Conditions: Pituitary Adenoma

Treatments: Procedure: Endonasal endoscopic pituitary surgery in semi-sitting position; Procedure: Endonasal endoscopic pituitary surgery in supine position

Study type: Interventional

Funder types: Other

Identifiers

NCT04584866

2020-02115 ch20Rychen;

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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))

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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54 participants in 2 patient groups

Study Intervention

Active Comparator group

Description:

Endonasal endoscopic pituitary surgery in semi-sitting position

Treatment:

Procedure: Endonasal endoscopic pituitary surgery in semi-sitting position

Control Intervention

Active Comparator group

Description:

Endonasal endoscopic pituitary surgery in supine position

Treatment:

Procedure: Endonasal endoscopic pituitary surgery in supine position