Sleep Disorders After TIPS

• Conditions: Sleep Disorder

• Registration Number: NCT03685994
• Lead Sponsor: West China Hospital

Brief Summary

The Purpose of a study to investigate the incidence of postoperative sleep disorders in patients undergoing transjugular intrahepatic portosystemic shunt ,and to analyze the relationship between risk factors and prognosis of sleep disorders.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-31
• Study First Submitted: 2018-09-23
• Study First Submitted QC: 2018-09-23
• Study First Posted: 2018-09-26
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-18
• Last Update Posted: 2019-04-22
• Primary Completion: 2019-08
• Study Completion: 2020-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. History of cirrhosis (clinical or by liver biopsy)
2. Portal hypertension patients with defined indications for TIPS treatment
3. Aged 18-75 years old
4. Signed written informed consent

Exclusion Criteria

1. mental or nervous system diseases
2. Patients with alcoholic cirrhosis who are still drinking
3. Accompanied by serious heart, lung, brain and kidney diseases
4. Preoperative diagnosis of sleep disorder
5. Patients who are illiteracy
6. The total score of the preoperative Hamilton anxiety scale was greater than or equal to 14 points, and the total score of 17 points of the Hamilton depression scale was greater than or equal to 18 points

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence of sleep disorders after TIPS	1 year	The number of patients who suffer from sleep disorders after TIPS

Secondary Outcome Measures

Name	Time	Method
mortality	1 year	The number of patients who died
Incidence of hepatic encephalopathy	1 year	The number of patients who suffer from hepatic encephalopathy

Trial Locations

Locations (1)

West China Hospital; 🇨🇳 Chengdu, Sichuan, China