Semi-sitting Versus Supine Position in Endoscopic Skull Base Surgery

Pituitary Adenoma Clinical Trial

— PosESS  

Official title:

Semi-sitting Versus Supine Position in Endoscopic Skull Base Surgery (PosESS-Study) - Study Protocol for a Randomized-controlled Single-blinded Superiority Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04584866
• Other study ID #: 2020-02115; ch20Rychen
• Status: Recruiting
• Phase: N/A
• Start date: January 22, 2021
• Est. completion date: June 2024

Study information

• Verified date: November 2023
• Source: University Hospital, Basel, Switzerland
• Contact: Jonathan Rychen, Dr. med.
• Phone: +41 61 328 51 84
• Email: Jonathan.Rychen[@]usb.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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))

Related Conditions & MeSH terms

• Adenoma
• Pituitary Adenoma
• Pituitary Diseases
• Pituitary Neoplasms

Intervention

Procedure:
• 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.
• Endonasal endoscopic pituitary surgery in supine position
Patients will be operated in the standard supine neutral position

Locations

Country	Name	City	State
Switzerland	Department of Neurosurgery, University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in intraoperative Mean Arterial Pressure (MAP)	MAP will be monitored during the whole surgery using the software Copra ©, which allows a continuous data extraction	Intraoperative
Secondary	Amount of intravenous fluid administered during surgery (ml)	Amount of intravenous fluid administered during surgery (ml)	Intraoperative
Secondary	Need for vasoactive drugs (vasopressors) (number)	Need for vasoactive drugs (vasopressors) (number)	at Day 1 (day of surgery)
Secondary	Incidence of air embolism (number)	Incidence of air embolism (number)	at Day 1 (day of surgery)
Secondary	Operative time (minutes)	Operative time (minutes)	During surgery
Secondary	Degree of descent or prolapse of the diaphragma sellae into the sellar cavity	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)	Intraoperative
Secondary	Occurrence of a cerebrospinal fluid (CSF) leak during surgery (assessed by the operating neurosurgeon) (yes/ no)	Occurrence of a cerebrospinal fluid (CSF) leak during surgery (assessed by the operating neurosurgeon)	During surgery
Secondary	Surgical ergonomics	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).	at Day 1 (day of surgery)
Secondary	Incidence of rhinoliquorrhoea (number)	Incidence of rhinoliquorrhoea (number)	at 3 months after surgery