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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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600119536
Enrollment
Unknown
Registered
2026-02-28
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sellar region tumor

Interventions

Group A:Standardized skull base reconstruction protocol in endoscopic extended endonasal transsphenoidal approach.
Group B:Standard skull base reconstruction protocol plus the absorbable and moldable skull base support plate.

Sponsors

Southern Medical University Southern Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 80 Years

Inclusion criteria

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 >= 70, with an expected survival period >= 24 months; 5. Laboratory indicators (such as liver and kidney function, blood routine, etc.) within the normal range or controllable range; 6. Signed the informed consent form and willing to participate in the study.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
CSF Leakage Rate;

Secondary

MeasureTime frame
30-day postoperative intracranial infection rate;Utilization rates of autologous fascia, fat, and pedicled mucosal flaps;Operation duration and postoperative hospital stay;Incidence of long-term nasal complications;

Countries

China

Contacts

Public ContactJun Pan

Southern Medical University Southern Hospital

1448875873@qq.com+86 13076878155

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026