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

RecruitingPhase 2Ages 1 Year - 80 YearsAllNanfang Hospital, Southern Medical University
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Aged 1-80 years, regardless of gender; 2. Diagnosed with sellar region tumors confirmed by clinical symptoms, endocrine examinations, and imaging data; 3. Planned to undergo extended endoscopic endonasal transsphenoidal approach surgery as determined by departmental discussion; 4. Karnofsky Performance Status score โ‰ฅ 70, with an expected survival period โ‰ฅ 24 months; 5. Laboratory indicators (such as liver and kidney function, blood routine, etc.) within the normal range or controllable range; 6. Sign the informed consent form and are willing to participate in the study. Exclusion Criteria: 1. Patients with other concurrent intracranial tumors or severe brain lesions; 2. Patients scheduled to undergo craniotomy or non-extended endoscopic endonasal transsphenoidal surgery; 3. Patients with uncontrolled severe heart, lung, kidney, or liver diseases; 4. Pregnant or lactating women; 5. Patients who have previously received radiotherapy or chemotherapy; 6. Patients with active nasal infections, inflammation, or severe nasal diseases; 7. Patients with a history of severe allergies to drugs or synthetic materials; 8. Patients with extensive skull base bone destruction evaluated by preoperative imaging, for whom it is estimated that support materials cannot be used during surgery; 9. Patients with mental illness or cognitive impairment who are unable to complete follow-up or understand the purpose of the study.
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What it tests

  • Absorbable and moldable skull base support plate
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Where

8 sites
The First People's Hospital Of Foshan
Foshan, China
Gaozhou People's Hospital
Gaozhou, China
Sun Yat-sen University Cancer Center
Guangzhou, China
Southern Medical University, Nanfang Hospital, Department of Neurosurgery
Guangzhou, China
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, China
Huizhou Central People's Hospital
Huizhou, China
The First People's Hospital of Zhaoqing
Zhaoqing, China
Liuzhou people's hospital
Liuzhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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