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

Pituitary Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04938401
• Other study ID #: Neurosurgery 5 Ward
• Status: Not yet recruiting
• Start date: July 2, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: YIing Wang
• Phone: 13588837622
• Email: Ukuk007[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1
• Est. completion date: December 31, 2023
• Est. primary completion date: October 31, 2021
• Gender: All
• Age group: 14 Years to 90 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

quitters; patients with incomplete clinical data;

Related Conditions & MeSH terms

• Pituitary Diseases
• Pituitary Neoplasms
• Pituitary Tumor

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Wang Ying supervisor nurse	Sir Run Run Shaw Hospital, Zhejiang Provincial People's Hospital, Zhejiang University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of epistaxis	Overall incidence of epistaxis	up to 24 weeks