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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Intervention | Active Comparator | Endonasal endoscopic pituitary surgery in semi-sitting position |
|
| Control Intervention | Active Comparator | Endonasal endoscopic pituitary surgery in supine position |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endonasal endoscopic pituitary surgery in semi-sitting position | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Amount of intravenous fluid administered during surgery (ml) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Rychen | Department of Neurosurgery, University Hospital Basel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurosurgery, University Hospital Basel | Basel | 4031 | Switzerland |
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| ID | Term |
|---|---|
| D010911 | Pituitary Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D007029 | Hypothalamic Neoplasms |
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| ID | Term |
|---|---|
| D016683 | Supine Position |
| ID | Term |
|---|---|
| D011187 | Posture |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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prospective randomized single-blinded controlled superiority trial
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| Endonasal endoscopic pituitary surgery in supine position | Procedure | Patients will be operated in the standard supine neutral position |
|
Amount of intravenous fluid administered during surgery (ml)
| Intraoperative |
| Need for vasoactive drugs (vasopressors) (number) | Need for vasoactive drugs (vasopressors) (number) | at Day 1 (day of surgery) |
| Incidence of air embolism (number) | Incidence of air embolism (number) | at Day 1 (day of surgery) |
| Operative time (minutes) | Operative time (minutes) | 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) | 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) | 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). | at Day 1 (day of surgery) |
| Incidence of rhinoliquorrhoea (number) | Incidence of rhinoliquorrhoea (number) | at 3 months after surgery |
| D015173 |
| Supratentorial Neoplasms |
| D001932 | Brain Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D007027 | Hypothalamic Diseases |
| D010900 | Pituitary Diseases |
| D004700 | Endocrine System Diseases |