Clinical Trial

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

Study acronym: EEEA-AMSBP
Recruiting Phase 2
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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.
Trial Details
NCT Number NCT07539792
Lead Sponsor Nanfang Hospital, Southern Medical University
Collaborators: First People's Hospital of Zhaoqing, Sun Yat-Sen University Cancer Center, Guangdong Provincial Hospital of Traditional Chinese Medicine, The People's Hospital of Gaozhou, First People's Hospital of Foshan, Huizhou Municipal Central Hospital, LiuZhou People's Hospital
Conditions Sellar Tumor, Endonasal Surgery, Csf Leakage
Enrollment 126 participants
Start Date 2026-04-01
Primary Completion 2029-03-31 (estimated)
Study Completion 2030-02-28 (estimated)
Updated on ClinicalTrials.gov 2026-04-20