The NO.2 Hospital of Baoding Department of Gastroenterology.
Shanxi Provincial People's Hospital Thoracic Surgery.
Medicine (Baltimore). 2021 Mar 19;100(11):e25138. doi: 10.1097/MD.0000000000025138.
Gastrointestinal complications and malnutrition are common problems that affect postoperative rehabilitation and survival of patients with esophageal cancer. Evidence has shown that probiotics have a positive effect on improving gastrointestinal complications and nutritional status of patients with esophageal cancer after surgery, but there is a lack of prospective studies on this topic. We designed this prospective randomized controlled trial to evaluate the effects of probiotics on gastrointestinal complications and nutritional status in patients with postoperative esophageal cancer.
This is a prospective, randomized, double-blind, placebo-controlled trial. It was approved by the Clinical Research Ethics Committee of our hospital. 192 patients will be randomly divided into probiotics group and the placebo group in a 1:1 ratio. After operation, probiotics and placebo will be given orally for 8 weeks. The indexes of nutritional status and incidence of digestive tract complications will be recorded and the data will be analyzed by SPSS 18.0 software.
This study will evaluate the effect of probiotics on gastrointestinal complications and nutritional status of postoperative patients with esophageal cancer. The results of this study will provide clinical basis for the use of probiotics in postoperative treatment of esophageal cancer.
OSF Registration number: D DOI 10.17605/OSF.IO/QHW86.
胃肠道并发症和营养不良是影响食管癌患者术后康复和生存的常见问题。有证据表明，益生菌对改善食管癌患者术后胃肠道并发症和营养状况有积极作用，但关于这一主题的前瞻性研究较少。我们设计了这项前瞻性随机对照试验，以评估益生菌对食管癌术后患者胃肠道并发症和营养状况的影响。
这是一项前瞻性、随机、双盲、安慰剂对照试验。它得到了我院临床研究伦理委员会的批准。将 192 名患者以 1:1 的比例随机分为益生菌组和安慰剂组。术后口服益生菌和安慰剂 8 周。记录营养状况指标和消化道并发症发生率，并采用 SPSS 18.0 软件进行数据分析。
本研究将评估益生菌对食管癌术后患者胃肠道并发症和营养状况的影响。该研究结果将为益生菌在食管癌术后治疗中的应用提供临床依据。
OSF 注册号：D DOI 10.17605/OSF.IO/QHW86。
