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Recruiting NCT04451473

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

No phase Interventional Lung Cancer Surgery ERAS

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Enhanced Recovery After Surgery (ERAS ), Traditional perioperative management without Enhanced Recovery After Surgery (ERAS ).
Who it may be relevant to
Registry conditions: Lung Cancer, Surgery, ERAS. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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
  • Procedure Traditional perioperative management without Enhanced Recovery After Surgery (ERAS )
    the treatment of procedure not abiding Guidelines for enhanced recovery after lung surgery

Primary outcome measures

  • intensive care unit utilization [Time frame: within 4 days after surgery]
  • the degree of pain [Time frame: within 4 days after surgery]
  • the time of ambulation [Time frame: within 48 hours after surgery]
  • the time for oral feed [Time frame: within 48 hours after surgery]
  • the time of hospitalization [Time frame: within 5 days after surgery]
  • complications [Time frame: within 7 days after surgery]
Secondary outcome measures (2)
  • disease- free survival [Time frame: within 5 years after surgery]
  • overall survival [Time frame: within 10 years after surgery]

Eligibility criteria

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

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

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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Yunpeng Zhao — Jinan

Publications

  • Ding Y, Zhou L, Shan L, Zhang W, Li P, Cong B, Tian Z, Zhao Y, Zhao X. Video- assisted thoracoscopic lung resection with or without enhanced recovery after surgery: a single institution, prospective randomized controlled study. Front Oncol. 2024 Nov 8;14:1474438. doi: 10.3389/fonc.2024.1474438. eCollection 2024. PMID 39582544

Identifiers

NCT: NCT04451473 · ERAS ZYP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗