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NCT Number: NCT04451473

Lung Surgery With Enhanced Recovery VS. Lung Surgery 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.

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Key information

Conditions

Lung Cancer ERAS Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Surgery Thoracic Neoplasms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yunpeng Zhao

Jinan, Shandong, 250033, China

Location status: Recruiting

Location contact

Yunpeng Zhao, Doc.

CONTACT

[email protected]

17660081916 ext. 17660081916

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Enhanced Recovery After Surgery (ERAS )

Procedure

the treatment of procedure according to Guidelines for enhanced recovery after lung surgery: recommendations of the ERAS Society and the ESTS

Traditional perioperative management without Enhanced Recovery After Surgery (ERAS )

Procedure

the treatment of procedure not abiding Guidelines for enhanced recovery after lung surgery

Primary outcomes

  1. intensive care unit utilization

    Time frame: within 4 days after surgery

    the time in intensive care unit utilization

  2. the degree of pain

    Time frame: within 4 days after surgery

    Visual Analogue Scale/Score

  3. the time of ambulation

    Time frame: within 48 hours after surgery

    the time after surgery that patients could leave the bed and walk

  4. the time for oral feed

    Time frame: within 48 hours after surgery

    the time for oral feed

  5. the time of hospitalization

    Time frame: within 5 days after surgery

    the time of hospitalization

  6. complications

    Time frame: within 7 days after surgery

    the rate of complications

Secondary outcomes

  1. disease- free survival

    Time frame: within 5 years after surgery

    disease- free survival

  2. overall survival

    Time frame: within 10 years after surgery

    overall survival

Study contacts

Contact information is provided by the study sponsor or research team.

Yunpeng Zhao, Doctor

CONTACT

[email protected]

17660081916 ext. 17660081916

Sponsors and collaborators

Lead sponsor

The Second Hospital of Shandong University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2027
First posted
Jun 30, 2020
Registry last updated
Nov 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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