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Postoperative nasal outcome of bilateral transseptal transnasal approach versus standard endoscopic transnasal approach for sellar region tumor surgery: a prospective randomized controlled clinical trial

Postoperative nasal outcome of bilateral transseptal transnasal approach versus standard endoscopic transnasal approach for sellar region tumor surgery: a prospective randomized controlled clinical trial

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100052482
Enrollment
Unknown
Registered
2021-10-28
Start date
2021-11-01
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

sellar region tumor

Interventions

transseptal group:bilateral transseptal approach
standard endoscopic group:standard endoscopic transnasal approach

Sponsors

Huashan Hospital Affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. aged 18-70 years old, junior high school education or above; 2. The clinical symptoms, signs, and imaging are consistent with the diagnosis of sellar tumor for the first time surgery patients, and there are clear indications for transsphenoidal surgery; 3. Inpatients awaiting surgery who have no contraindications to surgery after admission examination and evaluation; 4. Sign the informed consent for surgery and the informed consent for clinical trials.

Exclusion criteria

Exclusion criteria: 1. Obvious history of neuropsychiatric and physical serious diseases (including cardiovascular and cerebrovascular accidents, serious trauma, mental diseases, and other systemic tumor diseases) before treatment; 2. Have a clear history of nasal surgery, including nasal surgery such as tumor resection through nasal sella, rhinoplasty, correction of nasal septum deviation, removal of nasal polyps, sinusitis flushing, etc.; 3. There is a clear history of nasal diseases that affect the evaluation of smell, including nasopharyngeal tumors, nasal trauma, atrophic rhinitis, suppurative sinusitis, etc.; 4. AD/PD patients or other causes of preoperative hyposmia, disorders or allergies; 5. The tumor expanded significantly to the suprasellar, and the nasal septum mucosal flap should be used to repair the cerebrospinal fluid leakage during the operation; 6. Pregnant women; 7. Those who have participated in clinical trials of other drugs.

Design outcomes

Primary

MeasureTime frame
nasal structure;nasal function;Quality of Life;

Secondary

MeasureTime frame
surgical outcome;endocrine outcome;

Countries

China

Contacts

Public ContactYang Bojie

Neurosurgery, Huashan Hospital Affiliated to Fudan University

ybj8800@163.com+86 13901613855

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026