Neoplasms

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Nervous System Diseases

Gland and Hormone Related Diseases

Adenoma

Pituitary Diseases

Pituitary Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Hypothalamic Diseases

Brain Diseases

Central Nervous System Diseases

Endocrine System Diseases

Endocrine Gland Neoplasms

Hypothalamic Neoplasms

Supratentorial Neoplasms

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Surgical treatment consisted of an endoscopic endonasal approach using a rigid 0-degree endoscope, 18 cm in length and 4 mm in diameter.

Endoscopic Endonasal Pituitary Surgery

Gilda Cennamo

This study evaluates the structural parameters, by spectral domain optical coherence tomography (OCT), retinal vessel density, using OCT angiography, and visual acuity in patients that received endoscopic endonasal approach for the removal of an intra-suprasellar pituitary adenoma compressing the optic nerve.

The primary outcome was to detect the changes in visual acuity, retinal structural and vascular features at 48 hours and 1 year after Endoscopic Endonasal Approach for the removal of an intra-suprasellar pituitary adenoma compressing the optic nerve.

The secondary outcome was to identify potential biomarker that could predict the functional recovery at 1 year follow up.

Predictive OCTA Biomarkers After Endoscopic Endonasal Pituitary Surgery

Optical Cohrence Tomography Angiography as a New Predictive Biomarker in Anatomical and Functional Recovery After Endoscopic Endonasal Pituitary Surgery: a Prospective Study

8 patients with pituitary adenoma compressing optic chiasm. Changes in thickness of ganglion cell complex (microns) and in thickness of retinal nerve fiber layer (microns) before and 48 hours and 1 year after Endoscopic Endonasal Pituitary Surgery

8 patients with pituitary adenoma compressing optic chiasm. Changes in retinal vessel density (percent) in macular and papillary regions before and 48 hours and 1 year after Endoscopic Endonasal Pituitary Surgery

8 patients with pituitary adenoma compressing optic chiasm underwent Endoscopic Endonasal Pituitary Surgery.

Correlation between ganglion cell complex, retinal nerve fiber layer thicknesses (microns) at baseline and visual acuity recovery (logMAR) 1 year after surgery.

8 patients with pituitary adenoma compressing optic chiasm underwent Endoscopic Endonasal Pituitary Surgery.

Correlation between retinal vessel density (percent) at baseline and visual acuity recovery (logMAR) 1 year after surgery.

Federico II University

Principal Investigator

Surgical treatment consisted of an endoscopic endonasal approach using a rigid 0-degree endoscope, 18 cm in length and 4 mm in diameter

Endoscopic endonasal pituitary surgery

This study investigates the retinal vascular features, using optical coherence tomography angiography, in patients during one year's follow up after the endoscopic endonasal surgery to remove an intra-suprasellar pituitary adenoma compressing the optic nerve.

The role of the optical coherence tomography angiography to detect the changes in retinal vascular networks in patients after 48 hours and 1 year from the endoscopic endonasal surgery to remove an intra-suprasellar pituitary adenoma compressing the optic nerve.

The optical coherence tomography angiography allows a detailed and quantitative analysis of the retinal vascular networks and to follow their changes over time.

Long-term Follow up for Retinal Vascular Changes After Endoscopic Endonasal Pituitary Surgery.

Retinal Vascular Changes After Endoscopic Endonasal Pituitary Surgery During One Year's Follow up, by Optical Coherence Tomography Angiography

To evaluate the changes in vessel density of the retinal vascular network 48 hours and 1 year after endoscopic endonasal pituitary surgery for the removal of an intra-suprasellar pituitary adenoma compressing the optic nerve, using optical coherence tomography angiography. The parameter analyzed by optical coherence tomography angiography was the vessel density of the retinal vascular network.

This study evaluates the retinal vascular features using optical coherence tomography angiography in patients that received endoscopic endonasal approach for the removal of an intra-suprasellar pituitary adenoma compressing the optic nerve.

To investigate the potential role of optical coherence tomography angiography in predicting the postoperative recovery of retinal vascular network of the optic disc in patients before and at 3 months after Endoscopic Endonasal Approach for the removal of an intra-suprasellar pituitary adenoma compressing the optic nerve.

The optical coherence tomography angiography represents a novel and non-invasive diagnostic technique that allows a detailed analysis of retinal vascular features.

Evaluation of Early Retinal Vascular Modifications After Endoscopic Endonasal Pituitary Surgery

Early Retinal Vascular Modifications After Endoscopic Endonasal Pituitary Surgery: The Role of OCT- Angiography

To evaluate the role of optical coherence tomography angiography in predicting the recovery of the vessel density of the optic disc after surgery, using optical coherence tomography angiography (OCTA). The parameter analyzed by OCTA was the vessel density of the optic disc (percent)

Heart and Blood Diseases

Embolism

Embolism, Air

Endonasal endoscopic pituitary surgery in semi-sitting position

Endonasal endoscopic pituitary surgery in supine 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.

Patients will be operated in the standard supine neutral position

Jonathan Rychen, Dr. med.

Michel Röthlisberger, Dr. med.

Michel Roethlisberger, Dr. med.

Jonathan Rychen

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.

prospective randomized single-blinded controlled superiority trial

Semi-sitting Versus Supine Position in Endoscopic Skull Base Surgery

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

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. This will be assessed by an independent blinded neurosurgeon, who will watch the operative video after the surgery.

Amount of intravenous fluid administered during surgery (ml)

Need for vasoactive drugs (vasopressors) (number)

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)

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).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Predictive OCTA Biomarkers After Endoscopic Endonasal Pituitary Surgery	NCT04840771	Pituitary Adeno...	Endoscopic Endo...	40 Years - 65 Years	Federico II University
Long-term Follow up for Retinal Vascular Changes After Endoscopic Endonasal Pituitary Surgery.	NCT04546386	Pituitary Adeno...	Endoscopic endo...	45 Years - 65 Years	Federico II University
Long-term Follow up for Retinal Vascular Changes After Endoscopic Endonasal Pituitary Surgery.	NCT04546386	Pituitary Adeno...	Endoscopic endo...	45 Years - 65 Years	Federico II University
Evaluation of Early Retinal Vascular Modifications After Endoscopic Endonasal Pituitary Surgery	NCT04425954	Pituitary Adeno...	Endoscopic Endo...	45 Years - 65 Years	Federico II University
Semi-sitting Versus Supine Position in Endoscopic Skull Base Surgery	NCT04584866	Pituitary Adeno...	Endonasal endos... Endonasal endos...	18 Years -	University Hospital, Basel, Switzerland

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