Actively Recruiting
Efficacy and Safety Evaluation of Absorbable and Moldable Skull Base Support Plates in Extended Endoscopic Endonasal Transsphenoidal Surgery: A Prospective, Randomized, Controlled Study
Led by Nanfang Hospital, Southern Medical University · Updated on 2026-04-20
126
Participants Needed
8
Research Sites
204 weeks
Total Duration
On this page
Sponsors
N
Nanfang Hospital, Southern Medical University
Lead Sponsor
F
First People's Hospital of Zhaoqing
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Efficacy and Safety Evaluation of Absorbable and Moldable Skull Base Support Plates in Extended Endoscopic Endonasal Transsphenoidal Surgery: A Prospective, Randomized, Controlled Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 1 to 80 years, any gender
- Diagnosed with sellar region tumors confirmed by symptoms, endocrine tests, and imaging
- Planned for extended endoscopic endonasal transsphenoidal surgery as decided by medical team
- Karnofsky Performance Status score of 70 or higher with expected survival of at least 24 months
- Laboratory tests (liver, kidney, blood) within normal or controllable ranges
- Signed informed consent and willing to participate in the study
You will not qualify if you...
- Presence of other intracranial tumors or severe brain lesions
- Scheduled for craniotomy or non-extended endoscopic endonasal transsphenoidal surgery
- Uncontrolled severe heart, lung, kidney, or liver diseases
- Pregnant or breastfeeding women
- Previous radiotherapy or chemotherapy treatment
- Active nasal infections, inflammation, or severe nasal diseases
- History of severe allergies to drugs or synthetic materials
- Extensive skull base bone destruction preventing use of support materials
- Mental illness or cognitive impairment preventing follow-up or understanding of study purpose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
The First People's Hospital Of Foshan
Foshan, Guangdong, China
Not Yet Recruiting
2
Gaozhou People's Hospital
Gaozhou, Guangdong, China
Not Yet Recruiting
3
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Not Yet Recruiting
4
Southern Medical University, Nanfang Hospital, Department of Neurosurgery
Guangzhou, Guangdong, China, 510515
Actively Recruiting
5
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, China
Not Yet Recruiting
6
Huizhou Central People's Hospital
Huizhou, Guangdong, China
Not Yet Recruiting
7
The First People's Hospital of Zhaoqing
Zhaoqing, Guangdong, China
Not Yet Recruiting
8
Liuzhou people's hospital
Liuzhou, Guangxi, China
Not Yet Recruiting
Research Team
J
Jun Pan MD, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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