Primary objective: To evaluate the effect of absorbable and moldable skull base support plates used in extended endoscopic endonasal transsphenoidal surgery on the incidence of cerebrospinal fluid (CSF) rhinorrhea within 1 month after surgery.
Secondary objectives:
1. To evaluate the effect of absorbable and moldable skull base support plates used in extended endoscopic endonasal transsphenoidal surgery on the incidence of intracranial infection within 1 months after surgery; 2. To evaluate the effect of absorbable and moldable skull base support plates used in extended endoscopic endonasal transsphenoidal surgery on the duration of the surgery and length of postoperative hospital stay; 3. To monitor and evaluate the safety of absorbable and moldable skull base support plates, especially the occurrence of nasal complications.
Aged 1-80 years, regardless of gender;
Diagnosed with sellar region tumors confirmed by clinical symptoms, endocrine examinations, and imaging data;
Planned to undergo extended endoscopic endonasal transsphenoidal approach surgery as determined by departmental discussion;
Karnofsky Performance Status score ≥ 70, with an expected survival period ≥ 24 months;
Patients with other concurrent intracranial tumors or severe brain lesions;
Patients scheduled to undergo craniotomy or non-extended endoscopic endonasal transsphenoidal surgery;
Patients with uncontrolled severe heart, lung, kidney, or liver diseases;
Pregnant or lactating women;
Parallel
Absorbable and moldable skull base support plate
DeviceThe sbsorbable and moldable skull base support plate is used during the skull base repair phase of the surgery. Trimming: Measure the size of the skull base defect bone window (from the tuberculum sellae to the clival bone edge). Cut the malleable support plate slightly longer than this dimension. Shaping: Shape the plate according to the morphological changes of the sellar floor bone resulting from the lesion. In cases with no obvious sellar floor bone destruction (e.g., suprasellar craniopharyngioma), the support plate is shaped into a slight "S" curve to ensure tight apposition to the dural window and the inlay artificial dura, preventing the formation of intervening gaps. Placement: Since the support plate requires tight embedding under the anterior and posterior bone edges, bone edges at the tuberculum sellae and clivus should be preserved during sellar floor drilling according to surgical exposure and plate embedding requirements to facilitate secure fixation.
Incidence of cerebrospinal fluid (CSF) rhinorrhea
Confirmed by combining clinical symptoms, imaging examinations, and nasal endoscopy, including but not limited to the following indicators: Clinical symptoms: persistent high fever (maximum temperature \> 38.5 °C for more than 3 days), nausea and vomiting, decreased consciousness, positive meningeal irritation signs, etc.; Imaging examinations: CT or MRI showing fluid accumulation in the paranasal sinuses, intracranial pneumocephalus, etc.; Nasal endoscopy demonstrating persistent cerebrospinal fluid leakage from the sellar floor wound.
Incidence of intracranial infection
Clinical symptoms: persistent high fever (maximum temperature \> 38.5 °C for more than 3 days), nausea and vomiting, decreased consciousness, positive meningeal irritation signs, etc.; Confirmed by pathogenic examination of cerebrospinal fluid via lumbar puncture.
Utilization rate of autologous fascia, fat, and pedicled mucosal flap
Utilization rate of autologous fascia, fat, and pedicled mucosal flap during the surgery.
Operation duration
Operation duration of the surgery
Length of postoperative hospital stay
Time spended in the hosptial after the surgery
Incidence of long-term nasal complications
Evaluated based on the participant's symptom descriptions and otolaryngology outpatient assessments.
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Nanfang Hospital, Southern Medical University
Lead sponsor
First People's Hospital of Zhaoqing
Collaborator
Sun Yat-Sen University Cancer Center
Collaborator
Guangdong Provincial Hospital of Traditional Chinese Medicine
Collaborator
The People's Hospital of Gaozhou
Collaborator
First People's Hospital of Foshan
Collaborator
Huizhou Municipal Central Hospital
Collaborator
LiuZhou People's Hospital
Collaborator
