Effect of Re-education on Rebleeding Rate After Endoscopic Treatment in Liver Cirrhosis

NCT05302661 | Unknown

• 1 other identifier: 20211013-Li
• Study Type: interventional
• Target: 508
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective, randomized controlled study on whether re-education after discharge can reduce the rebleeding rate after endoscopic treatment of esophageal and gastric varices in patients with liver cirrhosis

Conditions

Liver Cirrhosis; Esophageal Varices Bleeding; Gastric Variceal Bleeding; Bleeding

Outcome Measures

Primary Outcomes (1)

• rebleeding

  rebleeding from any channel can be followed up through medical institutions or telephone

  2 yeas

Study Arms (2)

case group will receive re-education after leave hospital

EXPERIMENTAL

The participants were randomly divided into re-education group and non re-education group according to the random number table. The re-education group will receive regular re-education not noly when they leave hospital but also after leave hospital in our preset time by telephone or wechat. The content of re-education includes diet form and diet structure,medication compliance and regularity, and recheck compliance, moderate exercise and so on

Behavioral: re-education

control case group will receive no re-education after leave hospital

NO INTERVENTION

The participants were randomly divided into re-education group and non re-education group according to the random number table. without re-education group will receive regular re-education when they leave hospital.The content of re-education includes diet form and diet structure,medication compliance and regularity, and recheck compliance, moderate exercise and so on

Interventions

re-education BEHAVIORAL

Contact patients by phone or wechat and guide them

case group will receive re-education after leave hospital

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Esophageal and / or gastric varices ；
• liver cirrhosis ；
• patients receiving endoscopic treatment (esophagogastric variceal sclerosis and/or ligation) ；
• All subjects or their guardians must sign the subject consent form before entering the test

You may not qualify if:

• Patients with mental illness, severe hearing loss and unable to take care of themselves ;
• ASA score ≥ grade IV at discharge ;
• Hepatic encephalopathy ≥ stage II;
• Patients with liver cancer;
• Pregnant and lactating women;
• Patients who cannot sign informed consent

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital

Jinan, Shandong, 250012, China

Location

MeSH Terms

Conditions

Liver Cirrhosis; Hemorrhage

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yanjing Gao, MD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: March 31, 2022
• Study Start: February 19, 2022
• Primary Completion: February 19, 2024
• Study Completion: February 19, 2024
• Last Updated: March 31, 2022

Record last verified: 2022-02

Locations

CN (1)