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RECRUITING
NCT07539792
PHASE2

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

View on ClinicalTrials.gov

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

Interventions

DEVICE

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