Semi-sitting Versus Supine Position in Endoscopic Skull Base Surgery

University Hospital, Basel, Switzerland54 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Pituitary Adenoma

Interventions

Endonasal endoscopic pituitary surgery in semi-sitting positionPROCEDURE

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.

Endonasal endoscopic pituitary surgery in supine positionPROCEDURE

Patients will be operated in the standard supine neutral position

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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))

Locations (1)

Department of Neurosurgery, University Hospital Basel

Basel, Switzerland

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: During surgery

Secondary Outcomes

Change in intraoperative Mean Arterial Pressure (MAP)

Time frame: Intraoperative

Amount of intravenous fluid administered during surgery (ml)

Time frame: Intraoperative

Need for vasoactive drugs (vasopressors) (number)

Time frame: at Day 1 (day of surgery)

Incidence of air embolism (number)

Time frame: at Day 1 (day of surgery)

Operative time (minutes)

Data from ClinicalTrials.gov

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