Pituitary AdenomaPosESSNCT04584866
Semi-sitting Versus Supine Position in Endoscopic Skull Base Surgery
A study testing Endonasal endoscopic pituitary surgery in semi-sitting position and Endonasal endoscopic pituitary surgery in supine position in people with Pituitary Adenoma, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pituitary Adenoma
- What is being tested?
- Endonasal endoscopic pituitary surgery in semi-sitting position and Endonasal endoscopic pituitary surgery in supine position
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSwitzerland
- Study dates
- 22 Jan 2021to 29 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a presumed pituitary pathologies who are suitable for endoscopic endonasal surgical resection
Who cannot join
- 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))
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Neurosurgery, University Hospital Basel
Basel, 4031
About this study
Official title: Semi-sitting Versus Supine Position in Endoscopic Skull Base Surgery (PosESS-Study) - Study Protocol for a Randomized-controlled Single-blinded Superiority Trial
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.
Read the 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.
- Conditions
- Pituitary Adenoma
- Being tested
- Endonasal endoscopic pituitary surgery in semi-sitting position, Endonasal endoscopic pituitary surgery in supine position
- Keywords
- endoscopic endonasal pituitary surgery, endoscopic skull base surgery, intracranial venous pressure, venous air embolism
- Medical subject headings
- Pituitary Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endonasal endoscopic pituitary surgery in semi-sitting positionProcedure or surgery
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 or surgery
Patients will be operated in the standard supine neutral position
| Study group | Role | What they receive |
|---|---|---|
| Study Intervention | Active comparator | Endonasal endoscopic pituitary surgery in semi-sitting position Receives: Procedure: Endonasal endoscopic pituitary surgery in semi-sitting position |
| Control Intervention | Active comparator | Endonasal endoscopic pituitary surgery in supine position Receives: Procedure: Endonasal endoscopic pituitary surgery in supine position |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: During surgery
Secondary outcomes (9)
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
Measured: Intraoperative
Amount of intravenous fluid administered during surgery (ml)
Amount of intravenous fluid administered during surgery (ml)
Measured: Intraoperative
Need for vasoactive drugs (vasopressors) (number)
Need for vasoactive drugs (vasopressors) (number)
Measured: at Day 1 (day of surgery)
Incidence of air embolism (number)
Incidence of air embolism (number)
Measured: at Day 1 (day of surgery)
Operative time (minutes)
Operative time (minutes)
Measured: During surgery
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)
Measured: Intraoperative
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)
Measured: During surgery
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).
Measured: at Day 1 (day of surgery)
Incidence of rhinoliquorrhoea (number)
Incidence of rhinoliquorrhoea (number)
Measured: at 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start22 Jan 2021
- Primary completion29 Jun 2024
- Study completion29 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pituitary AdenomaStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective randomized single-blinded controlled superiority trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Rychen, Principal investigator, Department of Neurosurgery, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04584866
- Sponsor's protocol ID
- 2020-02115; ch20Rychen
- Acronym
- PosESS
- Status last verified
- Apr 2025
- First submitted
- 5 Oct 2020
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Semi-sitting Versus Supine Position in Endoscopic Skull Base Surgery (PosESS-Study) - Study Protocol for a Randomized-controlled Single-blinded Superiority Trial
- ClinicalTrials.gov ID
- NCT04584866
- Acronym / sponsor ID
- PosESS / 2020-02115; ch20Rychen
- Conditions
- Pituitary Adenoma
- Keywords
- endoscopic endonasal pituitary surgery, endoscopic skull base surgery, intracranial venous pressure, venous air embolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 22 Jan 2021 (actual)
- Primary completion
- 29 Jun 2024 (actual)
- Study completion
- 29 Jun 2024 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- prospective randomized single-blinded controlled superiority trial
| Arm | Type | Receives |
|---|---|---|
| Study Intervention | Active comparator | Procedure: Endonasal endoscopic pituitary surgery in semi-sitting positionEndonasal endoscopic pituitary surgery in semi-sitting position |
| Control Intervention | Active comparator | Procedure: Endonasal endoscopic pituitary surgery in supine positionEndonasal endoscopic pituitary surgery in supine position |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with a presumed pituitary pathologies who are suitable for endoscopic endonasal surgical resection
Key exclusion criteria (3 listed)
- 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))
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endonasal endoscopic pituitary surgery in semi-sitting positionPatients 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. | Procedure or surgery | Study Intervention |
| Endonasal endoscopic pituitary surgery in supine positionPatients will be operated in the standard supine neutral position | Procedure or surgery | Control Intervention |
Primary outcome
Intraoperative blood loss
Time frame: 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.
Frequency of interruption of the surgical workflow due to disturbing blood or a bleeding in the surgical field (number)
Time frame: 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.
9 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)
Time frame: During surgery
Degree of descent or prolapse of the diaphragma sellae into the sellar cavity
Time frame: Intraoperative
Occurrence of a cerebrospinal fluid (CSF) leak during surgery (assessed by the operating neurosurgeon) (yes/ no)
Time frame: During surgery
Surgical ergonomics
Time frame: at Day 1 (day of surgery)
Incidence of rhinoliquorrhoea (number)
Time frame: at 3 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Rychen principal investigator
Department of Neurosurgery, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endonasal endoscopic pituitary surgery in semi-sitting position and Endonasal endoscopic pituitary surgery in supine position in people with Pituitary Adenoma, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative blood loss (time frame: Intraoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.