Neoplasms

All Conditions

Nervous System Diseases

Gland and Hormone Related Diseases

Heart and Blood Diseases

Adenoma

Pituitary Diseases

Embolism

Embolism, Air

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

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.

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)

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).

University Hospital, Basel, Switzerland

Symptoms and General Pathology

Wounds and Injuries

Musculoskeletal Diseases

Rare Diseases

Hypertrophy

Cerebrospinal Fluid Leak

Skull Base Neoplasms

Pathological Conditions, Anatomical

Skull Neoplasms

Bone Neoplasms

Bone Diseases

Neurologic Manifestations

Craniocerebral Trauma

Trauma, Nervous System

Participant will have PuraGel (RADA16) Hydrogel applied to the nasoseptal flap harvest site following endoscopic skull base surgery

Participant will have a silastic splint (Non-Absorbable Packing) applied to the nasoseptal flap harvest site following endoscopic skull base surgery with no additional packing or agent

Participant will have silastic splint applied to nasoseptal flap harvest site

Non-Absorbable Packing (Silastic Splint)

Participant will have PuraGel (RADA16) Hydrogel applied to the nasoseptal flap harvest site

PuraGel (RADA16) Hydrogel

Satyan Sreenath, MD

The purpose of this study is to specifically evaluate the effectiveness of PuraGel, a RADA16 polypeptide hydrogel, in expediting post-operative healing and re-mucosalization of the nasoseptal flap harvest site during endoscopic skull base surgery and the impact on patient and sinonasal morbidity.

Briefly, multiple agents exist and have been long-studied in endoscopic sinus and septal surgery, which include non-absorbable agents and biodegradable, absorbable synthetic agents including extracellular matrix (ECM) based compounds and synthetic biopolymers. The goal of these agents has often been to reduce sinonasal crusting, postoperative bleeding, and synechia formation. With advancements in postoperative adjuncts, many options now exist for postoperative sinonasal packing including medicated products such as steroid-impregnated stents and chitosan-based absorbable packs.

Lastly, with respect to intra-operative adjuncts designed to foster healing in the postoperative period, PuraGel, a RADA16 polypeptide hydrogel, was identified as an ECM-based solution, which aids in wound healing, adhesion prevention, and hemostasis at the completion of the case. In hydrogel format, this agent forms a synthetic matrix that serves as a scaffold for mucosal healing while serving as a mechanical barrier on tissue surfaces, thereby limiting scarring. To date, there have been no studies evaluating the role of this gel-based compound in the postoperative period in endoscopic skull base surgery.

Thus, amongst all of these agents that have been previously studied to some degree in patients undergoing endoscopic sinus surgery, there has been limited study on their role in endoscopic skull base surgery and utility in reducing sinonasal morbidity in the postoperative setting. Therefore, our goal was to investigate and compare the impact of varying sinonasal agents in the nasal cavity following endoscopic skull base surgery. We hypothesize that the absorbable, ECM-based gel compound (PuraGel) demonstrates an improvement on postoperative healing rate and sinonasal crusting with reduced patient morbidity and improved patient comfort when compared to non-absorbable agents.

This will be double blinded (video endoscopy will be performed and scoring will be performed by non-operative surgeon, blinded to the intervention group).

Role of Novel RADA16 Hydrogel in Endoscopic Skull Base Surgery

Novel Application of RADA16 Hydrogel in Reducing Sinonasal Morbidity After Endoscopic Skull Base Surgery

Modified Lund-Kennedy nasal endoscopy score to rate mucosal edema, nasal crusting, and scarring. This will be double blinded (video endoscopy will be performed and scoring will be performed by non-operative surgeon, blinded to the intervention group). This scoring will address wound healing, adhesion formations. Scoring will be performed at 1 week, 4 weeks, and 12 weeks following surgery. The timing of these assessments is based on the routine postoperative follow-up schedule. No additional appointments will be made for the purposes of this study. We will be looking at the change in this score over time.

Minimum would be 0. Maximum would be 10. Higher score means worse outcome. The un-abbreviated title is Modified Lund-Kennedy nasal endoscopy score.

Patient-reported pain visual analog scale during postoperative debridement of the main nasal cavity. Minimum score is 1 (reflecting no pain) and the maximum score is 10 (reflecting extreme amount of pain).

Minimum would be 0. Maximum would be 10. Higher score means worse outcome. The un-abbreviated title is Patient-reported pain visual analog scale.

Postoperative, subjective QOL score with the validated Anterior Skull Base Nasal Inventory-12 (ASK-12) at 1 week, 4 weeks, and 12 weeks postoperatively.

Minimum would be 0. Maximum would be 72. Higher score means worse outcome. The un-abbreviated title is Anterior Skull Base Nasal Inventory-12.

Likert scale of mucosalization of the nasal septum graded by blinded reviewer via nasal endoscopy video

Minimum would be 0. Maximum would be 10. Higher score means worse outcome. The un-abbreviated title is Likert scale of mucosalization.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Semi-sitting Versus Supine Position in Endoscopic Skull Base Surgery	NCT04584866	Pituitary Adeno...	Endonasal endos... Endonasal endos...	18 Years -	University Hospital, Basel, Switzerland
Role of Novel RADA16 Hydrogel in Endoscopic Skull Base Surgery	NCT05898074	Skull Base Neop... Cerebrospinal F... Nasal; Hypertro...	Non-Absorbable ... PuraGel (RADA16...	18 Years -	Indiana University

Spots Global Cancer Trial Database for endoscopic skull base surgery