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

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ClinicalTrials.gov Identifier: NCT04938401
Recruitment Status : Not yet recruiting
First Posted : June 24, 2021
Last Update Posted : June 24, 2021
Sponsor:
Collaborators:
Sir Run Run Shaw Hospital
Zhejiang University
Zhejiang Provincial People's Hospital
Information provided by (Responsible Party):
Wang Ying supervisor nurse, Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Condition or disease
Pituitary Tumor

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 2 Years
Official Title: Construction and Application of a Risk Prediction Model Forepistaxis After Endoscopic Transsphenoidal Pituitary Tumor Resection
Estimated Study Start Date : July 2, 2021
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Group/Cohort
epistaxis
Postoperative pituitary tumor group with epistaxis
no epistaxis
Postoperative pituitary tumor group without epistaxis



Primary Outcome Measures :
  1. Incidence of epistaxis [ Time Frame: up to 24 weeks ]
    Overall incidence of epistaxis



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Ages Eligible for Study:   14 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients after transnasal sphenoidal resection of pituitary tumor
Criteria

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;


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04938401


Contacts
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Contact: YIing Wang 13588837622 Ukuk007@126.com

Sponsors and Collaborators
Wang Ying supervisor nurse
Sir Run Run Shaw Hospital
Zhejiang University
Zhejiang Provincial People's Hospital
Investigators
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Study Chair: YIing Wang Second Affiliated Hospital, School of Medicine, Zhejiang University
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Responsible Party: Wang Ying supervisor nurse, Neurosurgery 5 Ward, Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT04938401    
Other Study ID Numbers: Neurosurgery 5 Ward
First Posted: June 24, 2021    Key Record Dates
Last Update Posted: June 24, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Pituitary Neoplasms
Central Nervous System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Nervous System Diseases
Endocrine System Diseases