Semi-sitting Versus Supine Position in Endoscopic Skull Base Surgery

NCT04584866 | Completed

• 1 other identifier: 2020-02115; ch20Rychen
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Pituitary Adenoma

Keywords

endoscopic endonasal pituitary surgery; endoscopic skull base surgery; intracranial venous pressure; venous air embolism

Outcome Measures

Primary Outcomes (2)

• Intraoperative blood loss

  Intraoperative blood loss, calculated as follow: volume in the suction bag minus volume of rinsing water in Milliliters (ml). The surgery is divided into four steps: 1. endonasal phase, 2. osteodural exposure. 3. sellar stage and 4. skull base defect closure. For each step, the primary outcome will be assessed.

  Intraoperative

• Frequency of interruption of the surgical workflow due to disturbing blood or a bleeding in the surgical field (number)

  Frequency of interruption of the surgical workflow due to disturbing blood or a bleeding in the surgical field. This will be assessed by an independent blinded neurosurgeon, who will watch the operative video after the surgery.

  During surgery

Secondary Outcomes (9)

• Change in intraoperative Mean Arterial Pressure (MAP)

  Intraoperative

• Amount of intravenous fluid administered during surgery (ml)

  Intraoperative

• Need for vasoactive drugs (vasopressors) (number)

  at Day 1 (day of surgery)

• Incidence of air embolism (number)

  at Day 1 (day of surgery)

• Operative time (minutes)

  During surgery

Study Arms (2)

Study Intervention

ACTIVE COMPARATOR

Endonasal endoscopic pituitary surgery in semi-sitting position

Procedure: Endonasal endoscopic pituitary surgery in semi-sitting position

Control Intervention

ACTIVE COMPARATOR

Endonasal endoscopic pituitary surgery in supine position

Procedure: Endonasal endoscopic pituitary surgery in supine position

Interventions

Endonasal endoscopic pituitary surgery in semi-sitting position PROCEDURE

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.

Study Intervention

Endonasal endoscopic pituitary surgery in supine position PROCEDURE

Patients will be operated in the standard supine neutral position

Control Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a presumed pituitary pathologies who are suitable for endoscopic endonasal surgical resection

You may not qualify if:

• 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))

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Department of Neurosurgery, University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Pituitary Neoplasms

Interventions

Supine Position

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jonathan Rychen

  Department of Neurosurgery, University Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective randomized single-blinded controlled superiority trial

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 14, 2020
• Study Start: January 22, 2021
• Primary Completion: June 29, 2024
• Study Completion: June 29, 2024
• Last Updated: April 29, 2025

Record last verified: 2025-04

Locations

CH (1)