Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-26 @ 2:33 PM
Study NCT ID:
NCT04584866
Status:
COMPLETED
Last Update Posted:
2025-04-29
First Post:
2020-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Semi-sitting Versus Supine Position in Endoscopic Skull Base Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010911', 'term': 'Pituitary Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007029', 'term': 'Hypothalamic Neoplasms'}, {'id': 'D015173', 'term': 'Supratentorial Neoplasms'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D007027', 'term': 'Hypothalamic Diseases'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016683', 'term': 'Supine Position'}], 'ancestors': [{'id': 'D011187', 'term': 'Posture'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'prospective randomized single-blinded controlled superiority trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-06-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-28', 'studyFirstSubmitDate': '2020-10-05', 'studyFirstSubmitQcDate': '2020-10-06', 'lastUpdatePostDateStruct': {'date': '2025-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraoperative blood loss', 'timeFrame': 'Intraoperative', '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.'}, {'measure': 'Frequency of interruption of the surgical workflow due to disturbing blood or a bleeding in the surgical field (number)', 'timeFrame': 'During surgery', '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.'}], 'secondaryOutcomes': [{'measure': 'Change in intraoperative Mean Arterial Pressure (MAP)', 'timeFrame': 'Intraoperative', 'description': 'MAP will be monitored during the whole surgery using the software Copra ©, which allows a continuous data extraction'}, {'measure': 'Amount of intravenous fluid administered during surgery (ml)', 'timeFrame': 'Intraoperative', 'description': 'Amount of intravenous fluid administered during surgery (ml)'}, {'measure': 'Need for vasoactive drugs (vasopressors) (number)', 'timeFrame': 'at Day 1 (day of surgery)', 'description': 'Need for vasoactive drugs (vasopressors) (number)'}, {'measure': 'Incidence of air embolism (number)', 'timeFrame': 'at Day 1 (day of surgery)', 'description': 'Incidence of air embolism (number)'}, {'measure': 'Operative time (minutes)', 'timeFrame': 'During surgery', 'description': 'Operative time (minutes)'}, {'measure': 'Degree of descent or prolapse of the diaphragma sellae into the sellar cavity', 'timeFrame': 'Intraoperative', '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)'}, {'measure': 'Occurrence of a cerebrospinal fluid (CSF) leak during surgery (assessed by the operating neurosurgeon) (yes/ no)', 'timeFrame': 'During surgery', 'description': 'Occurrence of a cerebrospinal fluid (CSF) leak during surgery (assessed by the operating neurosurgeon)'}, {'measure': 'Surgical ergonomics', 'timeFrame': 'at Day 1 (day of surgery)', '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).'}, {'measure': 'Incidence of rhinoliquorrhoea (number)', 'timeFrame': 'at 3 months after surgery', 'description': 'Incidence of rhinoliquorrhoea (number)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['endoscopic endonasal pituitary surgery', 'endoscopic skull base surgery', 'intracranial venous pressure', 'venous air embolism'], 'conditions': ['Pituitary Adenoma']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a presumed pituitary pathologies who are suitable for endoscopic endonasal surgical resection\n\nExclusion Criteria:\n\n* Patients with known hemorrhagic or thrombophilic disorders\n* Patients with conditions associated with high central venous pressure: congestive heart failure, pulmonary hypertension, chronic obstructive pulmonary disease (COPD), interstitial lung disease, pregnancy\n* Patients with poor cardiopulmonary condition (unable to perform 4 metabolic equivalents without stopping (climb a flight of stairs))'}, 'identificationModule': {'nctId': 'NCT04584866', 'acronym': 'PosESS', 'briefTitle': 'Semi-sitting Versus Supine Position in Endoscopic Skull Base Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Semi-sitting Versus Supine Position in Endoscopic Skull Base Surgery (PosESS-Study) - Study Protocol for a Randomized-controlled Single-blinded Superiority Trial', 'orgStudyIdInfo': {'id': '2020-02115; ch20Rychen'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Study Intervention', 'description': 'Endonasal endoscopic pituitary surgery in semi-sitting position', 'interventionNames': ['Procedure: Endonasal endoscopic pituitary surgery in semi-sitting position']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Intervention', 'description': 'Endonasal endoscopic pituitary surgery in supine position', 'interventionNames': ['Procedure: Endonasal endoscopic pituitary surgery in supine position']}], 'interventions': [{'name': 'Endonasal endoscopic pituitary surgery in semi-sitting position', 'type': 'PROCEDURE', '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.', 'armGroupLabels': ['Study Intervention']}, {'name': 'Endonasal endoscopic pituitary surgery in supine position', 'type': 'PROCEDURE', 'description': 'Patients will be operated in the standard supine neutral position', 'armGroupLabels': ['Control Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'Department of Neurosurgery, University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Jonathan Rychen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Neurosurgery, University Hospital Basel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}