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Semi-sitting Versus Supine Position in Endoscopic Skull Base Surgery (PosESS)

Primary Purpose

Pituitary Adenoma

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Endonasal endoscopic pituitary surgery in semi-sitting position
Endonasal endoscopic pituitary surgery in supine position
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pituitary Adenoma focused on measuring endoscopic endonasal pituitary surgery, endoscopic skull base surgery, intracranial venous pressure, venous air embolism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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))

Sites / Locations

  • Department of Neurosurgery, University Hospital BaselRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Study Intervention

Control Intervention

Arm Description

Endonasal endoscopic pituitary surgery in semi-sitting position

Endonasal endoscopic pituitary surgery in supine position

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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
Amount of intravenous fluid administered during surgery (ml)
Amount of intravenous fluid administered during surgery (ml)
Need for vasoactive drugs (vasopressors) (number)
Need for vasoactive drugs (vasopressors) (number)
Incidence of air embolism (number)
Incidence of air embolism (number)
Operative time (minutes)
Operative time (minutes)
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)
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)
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).
Incidence of rhinoliquorrhoea (number)
Incidence of rhinoliquorrhoea (number)

Full Information

First Posted
October 5, 2020
Last Updated
April 11, 2022
Sponsor
University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT04584866
Brief Title
Semi-sitting Versus Supine Position in Endoscopic Skull Base Surgery
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 22, 2021 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pituitary Adenoma
Keywords
endoscopic endonasal pituitary surgery, endoscopic skull base surgery, intracranial venous pressure, venous air embolism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective randomized single-blinded controlled superiority trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study Intervention
Arm Type
Active Comparator
Arm Description
Endonasal endoscopic pituitary surgery in semi-sitting position
Arm Title
Control Intervention
Arm Type
Active Comparator
Arm Description
Endonasal endoscopic pituitary surgery in supine position
Intervention Type
Procedure
Intervention Name(s)
Endonasal endoscopic pituitary surgery in semi-sitting position
Intervention Description
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
Intervention Name(s)
Endonasal endoscopic pituitary surgery in supine position
Intervention Description
Patients will be operated in the standard supine neutral position
Primary Outcome Measure Information:
Title
Intraoperative blood loss
Description
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
Title
Frequency of interruption of the surgical workflow due to disturbing blood or a bleeding in the surgical field (number)
Description
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 Outcome Measure Information:
Title
Change in intraoperative Mean Arterial Pressure (MAP)
Description
MAP will be monitored during the whole surgery using the software Copra ©, which allows a continuous data extraction
Time Frame
Intraoperative
Title
Amount of intravenous fluid administered during surgery (ml)
Description
Amount of intravenous fluid administered during surgery (ml)
Time Frame
Intraoperative
Title
Need for vasoactive drugs (vasopressors) (number)
Description
Need for vasoactive drugs (vasopressors) (number)
Time Frame
at Day 1 (day of surgery)
Title
Incidence of air embolism (number)
Description
Incidence of air embolism (number)
Time Frame
at Day 1 (day of surgery)
Title
Operative time (minutes)
Description
Operative time (minutes)
Time Frame
During surgery
Title
Degree of descent or prolapse of the diaphragma sellae into the sellar cavity
Description
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)
Time Frame
Intraoperative
Title
Occurrence of a cerebrospinal fluid (CSF) leak during surgery (assessed by the operating neurosurgeon) (yes/ no)
Description
Occurrence of a cerebrospinal fluid (CSF) leak during surgery (assessed by the operating neurosurgeon)
Time Frame
During surgery
Title
Surgical ergonomics
Description
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).
Time Frame
at Day 1 (day of surgery)
Title
Incidence of rhinoliquorrhoea (number)
Description
Incidence of rhinoliquorrhoea (number)
Time Frame
at 3 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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))
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan Rychen, Dr. med.
Phone
+41 61 328 51 84
Email
Jonathan.Rychen@usb.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Michel Röthlisberger, Dr. med.
Phone
+41 61 328 54 48
Email
Michel.Roethlisberger@usb.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Rychen
Organizational Affiliation
Department of Neurosurgery, University Hospital Basel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurosurgery, University Hospital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Rychen, Dr. med.
Phone
+41 61 328 51 84
Email
Jonathan.Rychen@usb.ch
First Name & Middle Initial & Last Name & Degree
Michel Roethlisberger, Dr. med.
Phone
+41 61 328 54 48
Email
Michel.Roethlisberger@usb.ch

12. IPD Sharing Statement

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Semi-sitting Versus Supine Position in Endoscopic Skull Base Surgery

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