Efficacy and Safety Evaluation of Absorbable and Moldable Skull Base Support Plates in Extended Endoscopic Endonasal Transsphenoidal Surgery: A Prospective, Randomized, Controlled Study
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 80
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
The First People's Hospital Of Foshan
NOT_YET_RECRUITING
Foshan
Gaozhou People's Hospital
NOT_YET_RECRUITING
Gaozhou
Guangdong Provincial Hospital of Traditional Chinese Medicine
NOT_YET_RECRUITING
Guangzhou
Southern Medical University, Nanfang Hospital, Department of Neurosurgery
RECRUITING
Guangzhou
Sun Yat-sen University Cancer Center
NOT_YET_RECRUITING
Guangzhou
Huizhou Central People's Hospital
NOT_YET_RECRUITING
Huizhou
Liuzhou people's hospital
NOT_YET_RECRUITING
Liuzhou
The First People's Hospital of Zhaoqing
NOT_YET_RECRUITING
Zhaoqing
Contact Information
Primary
Jun Pan MD, Ph.D
1448875873@qq.com
+86-13076878155
Time Frame
Start Date:2026-04-01
Estimated Completion Date:2030-02-28
Participants
Target number of participants:126
Treatments
Experimental: Standard skull base reconstruction plus the absorbable and moldable skull base support plate
The intervention is performed during the skull base repair phase of the surgery. The sellar floor repair and reconstruction technique used in this study generally follows the multi-layer reconstruction and repair technique widely adopted in the classic endoscopic endonasal transsphenoidal approach :~Assess the intraoperative grade of cerebrospinal fluid (CSF) leakage (Esposito classification).~Obliterate the tumor cavity: After tumor resection, the subarachnoid space and sellar cavity are usually packed with gelatin sponge (or autologous fat in a minority of patients, etc.).~Repair the dura mater: Perform routine inlay repair with an impermeable artificial biomembrane to restore the dural layer.~Trimming, shaping, and placement of the skull base support plate. Covering with mucosa: Cover the outer surface of the support plate with a pedicled or free nasal septal mucosal flap, and pack and stabilize it with gelatin sponge
No_intervention: Standard skull base reconstruction protocol
No intervention is performed during the skull base repair phase of the surgery. The sellar floor repair and reconstruction technique used in this study generally follows the multi-layer reconstruction and repair technique widely adopted in the classic endoscopic endonasal transsphenoidal approach : Assess the intraoperative grade of cerebrospinal fluid (CSF) leakage (Esposito classification). Obliterate the tumor cavity: After tumor resection, the subarachnoid space and sellar cavity are usually packed with gelatin sponge (or autologous fat in a minority of patients, etc.). Repair the dura mater: Perform routine inlay repair with an impermeable artificial biomembrane to restore the dural layer. Cover with mucosa: Cover the outer surface of the dural layer with a pedicled or free nasal septal mucosal flap, and pack and stabilize it with gelatin sponge
Collaborators: Huizhou Municipal Central Hospital, The People's Hospital of Gaozhou, Sun Yat-Sen University Cancer Center, First People's Hospital of Zhaoqing, LiuZhou People's Hospital, First People's Hospital of Foshan, Guangdong Provincial Hospital of Traditional Chinese Medicine
Leads: Nanfang Hospital, Southern Medical University