Semi-sitting Versus Supine Position in Endoscopic Skull Base Surgery

Not Applicable

Completed

• Conditions: Pituitary Adenoma
• Interventions: Procedure: Endonasal endoscopic pituitary surgery in semi-sitting position; Procedure: Endonasal endoscopic pituitary surgery in supine position

• Registration Number: NCT04584866
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

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.

Study Timeline

• Study First Submitted: 2020-10-05
• Study First Submitted QC: 2020-10-06
• Study First Posted: 2020-10-14
• Study Start: 2021-01-22
• Primary Completion: 2024-06-29
• Study Completion: 2024-06-29
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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))

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Intervention	Endonasal endoscopic pituitary surgery in semi-sitting position	Endonasal endoscopic pituitary surgery in semi-sitting position
Control Intervention	Endonasal endoscopic pituitary surgery in supine position	Endonasal endoscopic pituitary surgery in supine position

Primary Outcome Measures

Name	Time	Method
Frequency of interruption of the surgical workflow due to disturbing blood or a bleeding in the surgical field (number)	During surgery	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.
Intraoperative blood loss	Intraoperative	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.

Secondary Outcome Measures

Name	Time	Method
Operative time (minutes)	During surgery	Operative time (minutes)
Degree of descent or prolapse of the diaphragma sellae into the sellar cavity	Intraoperative	Intraoperative assessment of the degree of descent or prolapse of the diaphragma sellae into the sellar cavity (class I to V, according to the classification of Abdelmaksoud et al)
Change in intraoperative Mean Arterial Pressure (MAP)	Intraoperative	MAP will be monitored during the whole surgery using the software Copra ©, which allows a continuous data extraction
Amount of intravenous fluid administered during surgery (ml)	Intraoperative	Amount of intravenous fluid administered during surgery (ml)
Need for vasoactive drugs (vasopressors) (number)	at Day 1 (day of surgery)	Need for vasoactive drugs (vasopressors) (number)
Incidence of air embolism (number)	at Day 1 (day of surgery)	Incidence of air embolism (number)
Occurrence of a cerebrospinal fluid (CSF) leak during surgery (assessed by the operating neurosurgeon) (yes/ no)	During surgery	Occurrence of a cerebrospinal fluid (CSF) leak during surgery (assessed by the operating neurosurgeon)
Surgical ergonomics	at Day 1 (day of surgery)	Surgical ergonomics assessed by the means of a standardized questionnaire. The surgeon will be asked to rate the intensity of neck and arm discomfort and the frequency of surgical flow interruption due to a suboptimal trajectory of the endoscope and the instruments due to the patient Position (1 = no discomfort, 2 = medium discomfort, 3 = high discomfort).
Incidence of rhinoliquorrhoea (number)	at 3 months after surgery	Incidence of rhinoliquorrhoea (number)

Trial Locations

Locations (1)

Department of Neurosurgery, University Hospital Basel; 🇨🇭 Basel, Switzerland