Self-reported Outcomes of Patients in ERAS Nursing

November 14, 2022 updated by: The Second Hospital of Shandong University

Effect of ERAS Nursing on Self-reported Outcomes of Patients Undergoing Minimally Invasive Lung Cancer Surgery

We aimed to evaluate the effect of ERAS nursing program on self-reported outcomes of patients undergoing minimally invasive lung cancer surgery, and compared the differences in length of hospital stay, complications, and readmission rate between ERAS and non-ERAS nursing programs

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Hongju Wang
  • Phone Number: 17660081878

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250033
        • Recruiting
        • The Second Hospital of Shandong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ≥18years,Minimally invasive elective surgery,cooperate

Exclusion Criteria:

  • Pneumonectomy was performed and converted to open surgery

Surgery intensive care, unable to cooperate (language

Speech disorders, psychopathology)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ERAS group
the patients accepting eras nursing protocol ;
Procedure: ERAS nursing
Patients were given education before surgery, fluid and anesthetic drug management during surgery, early ambulation, fluid management and early feeding after surgery, etc
Active Comparator: non-eras group
the patients not accepting eras nursing protocol ;
Procedure: non eras nursing
Patients were under the routine management without eras protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported Outcomes of Patients(PRO)
Time Frame: at baseline, daily after surgery, and weekly up to 4 after discharge weekly.
Use MD Anderson Symptom Checklist - Lung Cancer Symptom to measure severity and functional status
at baseline, daily after surgery, and weekly up to 4 after discharge weekly.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
length of stay (LOS), postoperative cardiopulmonary complications (CPC) and readmission rate (READM)
Time Frame: From admission to one month after the patient's discharge
length of stay (LOS), postoperative cardiopulmonary complications (CPC) and readmission rate (READM)
From admission to one month after the patient's discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Second Hospital of Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

August 31, 2027

Study Registration Dates

First Submitted

September 1, 2022

First Submitted That Met QC Criteria

September 1, 2022

First Posted (Actual)

September 6, 2022

Study Record Updates

Last Update Posted (Actual)

November 16, 2022

Last Update Submitted That Met QC Criteria

November 14, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • ERAS (PRO)-based study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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