Efficacy and Safety Evaluation of Absorbable and Moldable Skull Base Support Plates in Extended Endoscopic Endonasal Transsphenoidal Surgery: A Prospective, Randomized, Controlled Study

Summary

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.

Eligibility

Inclusion Criteria:

1. Aged 1-80 years, regardless of gender;
2. Diagnosed with sellar region tumors confirmed by clinical symptoms, endocrine examinations, and imaging data;
3. Planned to undergo extended endoscopic endonasal transsphenoidal approach surgery as determined by departmental discussion;
4. Karnofsky Performance Status score ≥ 70, with an expected survival period ≥ 24 months;
5. Laboratory indicators (such as liver and kidney function, blood routine, etc.) within the normal range or controllable range;
6. Sign the informed consent form and are willing to participate in the study.

Exclusion Criteria:

1. Patients with other concurrent intracranial tumors or severe brain lesions;
2. Patients scheduled to undergo craniotomy or non-extended endoscopic endonasal transsphenoidal surgery;
3. Patients with uncontrolled severe heart, lung, kidney, or liver diseases;
4. Pregnant or lactating women;
5. Patients who have previously received radiotherapy or chemotherapy;
6. Patients with active nasal infections, inflammation, or severe nasal diseases;
7. Patients with a history of severe allergies to drugs or synthetic materials;
8. Patients with extensive skull base bone destruction evaluated by preoperative imaging, for whom it is estimated that support materials cannot be used during surgery;
9. Patients with mental illness or cognitive impairment who are unable to complete follow-up or understand the purpose of the study.

Conditions4

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