Semi-sitting Versus Supine Position in Endoscopic Skull Base Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-22

Study Completion Date

2024-06-29

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pituitary Adenoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

prospective randomized single-blinded controlled superiority trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Study Intervention

Endonasal endoscopic pituitary surgery in semi-sitting position

Group Type ACTIVE_COMPARATOR

Endonasal endoscopic pituitary surgery in semi-sitting position

Intervention Type 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.

Control Intervention

Endonasal endoscopic pituitary surgery in supine position

Group Type ACTIVE_COMPARATOR

Endonasal endoscopic pituitary surgery in supine position

Intervention Type PROCEDURE

Patients will be operated in the standard supine neutral position

Interventions

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Endonasal endoscopic pituitary surgery in semi-sitting position

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.

Intervention Type PROCEDURE

Endonasal endoscopic pituitary surgery in supine position

Patients will be operated in the standard supine neutral position

Intervention Type PROCEDURE

Eligibility Criteria

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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))

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No