Evaluating Absorbable and Moldable Skull Base Support Plates in Extended Endoscopic Endonasal Transsphenoidal Surgery to Reduce CSF Leak and Improve Safety

What this Trial Is About

Researchers are evaluating the use of absorbable and moldable skull base support plates in patients undergoing extended endoscopic endonasal transsphenoidal surgery for sellar region tumors. The study aims to compare the incidence of cerebrospinal fluid CSF rhinorrhea within one month after surgery between patients receiving standard sellar floor repair combined with the support plate and those receiving standard repair alone. This phase II, randomized, controlled trial also assesses intracranial infection rates, surgery duration, hospital stay length, and safety, including nasal complications. Participants will be randomly assigned to one of two groups. The experimental group will receive a skull base repair that includes the use of a shaped and trimmed absorbable and moldable support plate placed during surgery, covered with nasal septal mucosa and stabilized with gelatin sponge. The control group will undergo the standard multi-layer sellar floor repair without the support plate but with similar packing and mucosal coverage. The trial follows a 11 parallel design and plans to enroll approximately 126 patients. During the study, participants will be monitored for CSF rhinorrhea and intracranial infections within the first month after surgery using clinical symptoms, imaging, and nasal endoscopy. Researchers will also record surgery duration and hospital stay length. Safety will be assessed by tracking treatment-related adverse events, especially nasal complications. Follow-up includes face-to-face visits for patients returning for reexamination and telephone follow-ups for those who cannot. Data will be analyzed using established statistical methods to evaluate the outcomes and safety over the study period.

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