About this trial
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 criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Absorbable and moldable skull base support plate
Treatment groups
Sponsors and collaborators
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