Construction and Application of a Risk Prediction Model Forepistaxis After Pituitary Tumor Resection

NCT04938401 | Unknown

• 1 other identifier: Neurosurgery 5 Ward
• Study Type: observational
• Target: 1
• Locations: 0 countries
• Sites: N/A

Brief Summary

(1) Objective to establish an evaluation system for predicting the risk of epistaxis after endoscopic transsphenoidal pituitary surgery（ 2) Objective to determine the risk factors of epistaxis after endoscopic transsphenoidal pituitary adenoma surgery. Referring to domestic and foreign literature, combined with experts' opinions, the related risk factors that may cause postoperative nosebleed of pituitary adenoma are: 22 patients and surgical factors. 3) Objective to establish a risk prediction model of epistaxis after endoscopic transsphenoidal pituitary tumor resection. According to the occurrence of epistaxis, the patients in the modeling group were divided into epistaxis group and non epistaxis group. The risk factors of epistaxis were taken as the independent variable, and the occurrence of epistaxis was taken as the dependent variable. The variables with statistical significance in univariate analysis were included in the multivariate logistic regression model, and the risk prediction model of epistaxis after pituitary tumor resection was established by back LR method.(4) Objective to verify the risk prediction model of endoscopic transsphenoidal pituitary adenoma epistaxis. The validation model is used to validate the prediction model, and the Hosmer-Lemeshow degree is used to match the model. The area under the receiver operating characteristic curve (ROC) was used to evaluate the validity of the model.(5) Application of risk prediction model.

Conditions

Pituitary Tumor

Outcome Measures

Primary Outcomes (1)

• Incidence of epistaxis

  Overall incidence of epistaxis

  up to 24 weeks

Study Arms (2)

epistaxis

Postoperative pituitary tumor group with epistaxis

no epistaxis

Postoperative pituitary tumor group without epistaxis

Eligibility Criteria

• Age: 14 Years - 90 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients after transnasal sphenoidal resection of pituitary tumor

You may qualify if:

• Those who met the diagnostic criteria of pituitary tumor and received transsphenoidal endoscopic surgery during hospitalization; Patients with informed consent; Age ≥ 14 years old.

You may not qualify if:

• quitters; patients with incomplete clinical data;

Sponsors & Collaborators

• Wang Ying supervisor nurse: lead
• Sir Run Run Shaw Hospital: collaborator
• Zhejiang University: collaborator
• Zhejiang Provincial People's Hospital: collaborator

MeSH Terms

Conditions

Pituitary Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases

Study Officials

• YIing Wang

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  STUDY CHAIR

Central Study Contacts

YIing Wang

CONTACT

13588837622; Ukuk007@126.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Neurosurgery 5 Ward

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 24, 2021
• Study Start: July 2, 2021
• Primary Completion: October 31, 2021
• Study Completion: December 31, 2023
• Last Updated: June 24, 2021

Record last verified: 2021-06