Efficacy and Safety Evaluation of Absorbable and Moldable Skull Base Support Plates in Extended Endoscopic Endonasal Transsphenoidal Surgery: A Prospective, Randomized, Controlled Study
Nanfang Hospital, Southern Medical University
126 participants
Apr 1, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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;
- Laboratory indicators (such as liver and kidney function, blood routine, etc.) within the normal range or controllable range;
- Sign the informed consent form and are willing to participate in the study.
Exclusion Criteria9
- 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;
- Patients who have previously received radiotherapy or chemotherapy;
- Patients with active nasal infections, inflammation, or severe nasal diseases;
- Patients with a history of severe allergies to drugs or synthetic materials;
- Patients with extensive skull base bone destruction evaluated by preoperative imaging, for whom it is estimated that support materials cannot be used during surgery;
- 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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Interventions
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.
Locations(8)
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NCT07539792