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Efficacy and Safety Evaluation of Absorbable and Moldable Skull Base Support Plates in Extended Endoscopic Endonasal Transsphenoidal Surgery: A Prospective, Randomized, Controlled Study
Sponsor: Nanfang Hospital, Southern Medical University
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.
Key Details
Gender
All
Age Range
1 Year - 80 Years
Study Type
INTERVENTIONAL
Enrollment
126
Start Date
2026-04-01
Completion Date
2030-02-28
Last Updated
2026-04-20
Healthy Volunteers
No
Conditions
Interventions
Absorbable and moldable skull base support plate
The 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.
Locations (8)
The First People's Hospital Of Foshan
Foshan, Guangdong, China
Gaozhou People's Hospital
Gaozhou, Guangdong, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Southern Medical University, Nanfang Hospital, Department of Neurosurgery
Guangzhou, Guangdong, China
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, China
Huizhou Central People's Hospital
Huizhou, Guangdong, China
The First People's Hospital of Zhaoqing
Zhaoqing, Guangdong, China
Liuzhou people's hospital
Liuchow, Guangxi, China