NCT03685994

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 31, 2018

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 26, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

April 22, 2019

Status Verified

April 1, 2019

Enrollment Period

11 months

First QC Date

September 23, 2018

Last Update Submit

April 18, 2019

Conditions

Sleep Disorder

Outcome Measures

Primary Outcomes (1)

  • The incidence of sleep disorders after TIPS

    The number of patients who suffer from sleep disorders after TIPS

    1 year

Secondary Outcomes (2)

  • Incidence of hepatic encephalopathy

    1 year

  • mortality

    1 year

Study Arms (1)

the patients who will undergo TIPS

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

100 patients who underwent TIPS in our hospital due to cirrhosis and portal hypertension.

You may qualify if:

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

You may not qualify if:

  • mental or nervous system diseases
  • Patients with alcoholic cirrhosis who are still drinking
  • Accompanied by serious heart, lung, brain and kidney diseases
  • Preoperative diagnosis of sleep disorder
  • Patients who are illiteracy
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

RECRUITING

Related Publications (1)

  • Zhao M, Yan Y, Wang X, Liu B, Luo X. Sleep disturbance in patients with cirrhosis and transjugular intrahepatic portosystemic shunt. BMC Gastroenterol. 2024 Oct 28;24(1):381. doi: 10.1186/s12876-024-03470-x.

    PMID: 39465397DERIVED

MeSH Terms

Conditions

Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Central Study Contacts

Xufeng Luo, MD

CONTACT

+86 13880098212luo_xuefeng@yeah.net

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

September 23, 2018

First Posted

September 26, 2018

Study Start

August 31, 2018

Primary Completion

August 1, 2019

Study Completion

August 1, 2020

Last Updated

April 22, 2019

Record last verified: 2019-04

Locations

CN(1)