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

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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

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

Trial contacts and locations

0

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Central trial contact

Michel Röthlisberger, Dr. med.; Jonathan Rychen, Dr. med.

Data sourced from clinicaltrials.gov

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