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
47 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
Researchers are evaluating the use of absorbable and moldable skull base support plates in patients undergoing extended endoscopic endonasal transsphenoidal surgery for sellar region tumors. The study aims to compare the incidence of cerebrospinal fluid (CSF) rhinorrhea within one month after surgery between patients receiving standard sellar floor repair combined with the support plate and those receiving standard repair alone. This phase II, randomized, controlled trial also assesses intracranial infection rates, surgery duration, hospital stay length, and safety, including nasal complications. Participants will be randomly assigned to one of two groups. The experimental group will receive a skull base repair that includes the use of a shaped and trimmed absorbable and moldable support plate placed during surgery, covered with nasal septal mucosa and stabilized with gelatin sponge. The control group will undergo the standard multi-layer sellar floor repair without the support plate but with similar packing and mucosal coverage. The trial follows a 1:1 parallel design and plans to enroll approximately 126 patients. During the study, participants will be monitored for CSF rhinorrhea and intracranial infections within the first month after surgery using clinical symptoms, imaging, and nasal endoscopy. Researchers will also record surgery duration and hospital stay length. Safety will be assessed by tracking treatment-related adverse events, especially nasal complications. Follow-up includes face-to-face visits for patients returning for reexamination and telephone follow-ups for those who cannot. Data will be analyzed using established statistical methods to evaluate the outcomes and safety over the study period.
CONDITIONS
Brief 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 1-80 years, any gender
- Diagnosed with sellar region tumors confirmed by clinical symptoms, endocrine tests, and imaging
- Planned to undergo extended endoscopic endonasal transsphenoidal surgery
- Karnofsky Performance Status score of 70 or higher with expected survival of at least 24 months
- Laboratory tests within normal or controllable range
- Signed informed consent and willing to participate
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
- Active nasal infections, inflammation, or severe nasal diseases
- History of severe allergies to drugs or synthetic materials
- Extensive skull base bone destruction making support plate use impossible
- Mental illness or cognitive impairment preventing follow-up or understanding of the study
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day and immediate hospital stay
Participants undergo extended endoscopic endonasal transsphenoidal surgery with skull base repair. Depending on the group, the repair includes standard reconstruction alone or combined with an absorbable and moldable skull base support plate. The surgery involves tumor removal, packing of the tumor cavity, dura repair, and placement of mucosal flaps.
1 surgery visit and hospital stay
Duration - Up to 1 month after surgery
Participants are monitored for surgical outcomes including incidence of cerebrospinal fluid (CSF) rhinorrhea and intracranial infection within 1 month after surgery. Follow-up includes face-to-face visits for hospital reexamination or telephone follow-up for those unable to return.
Face-to-face and telephone follow-up as needed
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
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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