Lung Surgery With Enhanced Recovery VS. Lung Surgery Without Enhanced Recovery

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

The Short Term and Long Term Comparison of Lung Surgery With or Without Enhanced Recovery

Objective: The adoption of Enhanced Recovery Surgery programs in lung resection is relatively recent with limited outcome data. This study aimed to determine the impact of an Enhanced Recovery Surgery pathway on short- term and long- term results in patients undergoing lung resection for primary lung cancer.

Methods: A Randomized Controlled Trial was designed to collect the perioperative data on consecutive patients undergoing lung resection for primary lung cancer. Patients will be randomizely assigned to the ERAS- Group and Control- Group. Short-term and long- term effect will be compared between the two groups.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

350

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 Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250033

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria: patients with stage I-IIIa Non-small-cell Lung Cancer underwent radical resection or other benign lung lesions need VATS surgery.

-

Exclusion Criteria: cardio-pulmonary function couldn't tolerate surgery

-

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ERAS- Group
Patients underwent surgery for lung cancer accepted the enhanced recovery after surgery (ERAS).
Procedure: Enhanced Recovery After Surgery (ERAS )
the treatment of procedure according to Guidelines for enhanced recovery after lung surgery: recommendations of the ERAS Society and the ESTS
OTHER: Control- Group
Patients underwent surgery for lung cancer without enhanced recovery after surgery (ERAS).
Procedure: Traditional perioperative management without Enhanced Recovery After Surgery (ERAS )
the treatment of procedure not abiding Guidelines for enhanced recovery after lung surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intensive care unit utilization
Time Frame: within 4 days after surgery
the time in intensive care unit utilization
within 4 days after surgery
the degree of pain
Time Frame: within 4 days after surgery
Visual Analogue Scale/Score
within 4 days after surgery
the time of ambulation
Time Frame: within 48 hours after surgery
the time after surgery that patients could leave the bed and walk
within 48 hours after surgery
the time for oral feed
Time Frame: within 48 hours after surgery
the time for oral feed
within 48 hours after surgery
the time of hospitalization
Time Frame: within 5 days after surgery
the time of hospitalization
within 5 days after surgery
complications
Time Frame: within 7 days after surgery
the rate of complications
within 7 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disease- free survival
Time Frame: within 5 years after surgery
disease- free survival
within 5 years after surgery
overall survival
Time Frame: within 10 years after surgery
overall survival
within 10 years after surgery

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 8, 2019

Primary Completion (ANTICIPATED)

June 30, 2023

Study Completion (ANTICIPATED)

June 30, 2027

Study Registration Dates

First Submitted

June 27, 2020

First Submitted That Met QC Criteria

June 27, 2020

First Posted (ACTUAL)

June 30, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 16, 2022

Last Update Submitted That Met QC Criteria

November 14, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • ERAS ZYP

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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