Effect of Pulmonary Rehabilitation on Perioperative Outcomes in Smoker Patients With Lung Cancer — PREPOSE  

Pulmonary Neoplasm Clinical Trial

Official title: Effects of Pulmonary Rehabilitation and Airway Management on Short-term and Long-term Perioperative Results of Lobectomy in Smoker Patients With Lung Cancer

Status Recruiting

Clinical Trial Summary

It is reported that smoker patients (>400 cigarette/year) will suffer more postoperative complications than non-smoker patients after lobectomy. Evidences has suggested pulmonary rehabilitation could reduce the pulmonary complications after thoracic surgery. However, the effect and long-term results of pulmonary rehabilitation on smoker patients have not been studied. The purpose of this study is to determine whether pulmonary rehabilitation is effective to smoker patients who underwent lobectomy.

Clinical Trial Description

In China, the smoker population is about 300 hundred million. Tobacco has become one of the world's public health problem. 30 percent of global surgery patients have smoking history. It is reported that smoker patients (>400 cigarette/year) will suffer more postoperative complications than non-smoker patients after lobectomy (38.2% vs 12.5%). Smoking is an independent risk factor of postoperative complications of cardiothoracic surgery. Evidences showed that smoking had a negative effect on airway management which plays an important role in postoperative recovery for thoracic surgery. Therefore, we hypothesise that intervention-related study to find a way to reduce postoperative complications for smoker patients is significantly meaningful in improving the overall outcome after pulmonary surgery as 80 percent of patients with lung cancer are smoker in China. Recently, a series of strategies on airway management have been proposed by clinical doctors. As one of the important parts of airway management, pulmonary rehabilitation has been demonstrated by evidence-base medicine to reduce the pulmonary complications after thoracic surgery and increase the breathing capacity. According to the reported literatures, the effect and long-term results of pulmonary rehabilitation on smoker patients have not been studied, so we designed this randomized controlled trial to determine whether pulmonary rehabilitation would be effective to smoker patients who underwent lobectomy which was associated with significant loss of lung function.

According to the reported papers in China, main observation index in experimental group was about 25.7, and in control group was about 10%. At the level of α=0.05 (Bilateral), power of test (1-β)=0.80, ratio=1:1. The estimated minimum required sample size of each group was 93 cases, the statistical loss rate was set as 10%. The overall sample size of this study was about 200 cases. ;

Related Conditions & MeSH terms

• Lung Neoplasms
• Pulmonary Neoplasm

• NCT number: NCT03010033
• Study type: Interventional
• Source: Ruijin Hospital
• Contact: Ding-Pei Han, master
• Phone: 00862164370045
• Email: dmhan1985@163.com
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2017
• Completion date: December 2022