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

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.

Conditions

• Sellar Tumor
• Endonasal Surgery
• Csf Leakage

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.

Sponsors & Collaborators

• The First People's Hospital of Zhaoqing

  collaborator UNKNOWN

• Sun Yat-Sen University Cancer Center

  collaborator OTHER

• Guangdong Provincial Hospital of Traditional Chinese Medicine

  collaborator OTHER

• The People's Hospital of Gaozhou

  collaborator OTHER

• First People's Hospital of Foshan

  collaborator OTHER

• Huizhou Municipal Central Hospital

  collaborator OTHER

• LiuZhou People's Hospital

  collaborator OTHER

• Nanfang Hospital, Southern Medical University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Year

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-01

Primary Completion

2029-03-31

Completion

2030-02-28

Countries

• China

Study Locations