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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1-80
SponsorNanfang Hospital, Southern Medical University

About this trial

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.

Eligibility criteria

Qualifiers

Aged 1-80 years, regardless of gender;

Diagnosed with sellar region tumors confirmed by clinical symptoms, endocrine examinations, and imaging data;

Planned to undergo extended endoscopic endonasal transsphenoidal approach surgery as determined by departmental discussion;

Karnofsky Performance Status score ≥ 70, with an expected survival period ≥ 24 months;

Disqualifiers

Patients with other concurrent intracranial tumors or severe brain lesions;

Patients scheduled to undergo craniotomy or non-extended endoscopic endonasal transsphenoidal surgery;

Patients with uncontrolled severe heart, lung, kidney, or liver diseases;

Pregnant or lactating women;

Trial design

Treatments tested in this trial

  • Absorbable and moldable skull base support plate

Treatment groups

126 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Nanfang Hospital, Southern Medical University

Lead sponsor

First People's Hospital of Zhaoqing

Collaborator

Sun Yat-Sen University Cancer Center

Collaborator

Guangdong Provincial Hospital of Traditional Chinese Medicine

Collaborator

The People's Hospital of Gaozhou

Collaborator

First People's Hospital of Foshan

Collaborator

Huizhou Municipal Central Hospital

Collaborator

LiuZhou People's Hospital

Collaborator