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临床试验/NCT05892263
NCT05892263已完成不适用

The Study Wonders Whether Early Gastric Force Feeding Can Reduce the Infection Rate and Whether the External Reaction Can Simultaneously Promote the Gastric Motility of the Gastrointestinal Tract Peristalsis Can Reduce the Complications of Postoperative Neck and Wound Anastomosis Leakage, Provide Postoperative Care for Intact Esophagus, and Reduce Postoperative Mortality.

National Taiwan University Hospital2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2022年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
2
主要终点
gastrointestinal emptying time

研究概览

简要总结

Esophagectomy with reconstruction for esophageal cancer is associated with delayed gastrointestinal recovery and substantial postoperative morbidity. Whether early jejunostomy-based enteral feeding can be safely initiated after esophagectomy remains uncertain.

详细描述

Esophageal cancer remains a major gastrointestinal malignancy worldwide. For patients with resectable disease, esophagectomy with reconstruction remains the main curative treatment. Although the overall 5-year survival rate of esophageal cancer has historically been poor, often around 10% to 15%, contemporary surgical series have reported 5-year survival rates approaching 40% or higher in selected patients undergoing resection. Even so, esophagectomy remains a high-risk procedure. Despite advances in minimally invasive techniques and perioperative care pathways, postoperative complications such as pulmonary infection, delayed gastrointestinal recovery, and anastomosis-related complications remain common. Postoperative ileus and systemic inflammatory response can prolong intensive care unit (ICU) and hospital stay, increase health care resource utilization, and add substantially to patient burden. Accordingly, optimizing postoperative recovery has become a major priority in contemporary esophageal surgery.

The intestine is increasingly recognized as a key organ in immune and metabolic regulation. Delayed enteral nutrition may lead to intestinal mucosal atrophy, impaired gut barrier function, and bacterial translocation, thereby exacerbating systemic inflammatory responses. Current critical care and clinical nutrition guidelines generally recommend initiation of enteral nutrition within 24 to 48 hours in hemodynamically stable patients to preserve intestinal integrity and reduce the risk of infection. Enhanced recovery after surgery (ERAS) protocols likewise advocate early enteral nutrition as part of strategies to accelerate postoperative recovery. Although previous studies

have suggested that early enteral nutrition may improve gastrointestinal recovery and reduce infectious complications, its clinical value after esophagectomy with reconstruction has not yet been clearly established. Concerns remain regarding possible adverse effects of early feeding on anastomotic healing, gastric emptying, and postoperative respiratory function, and published findings have varied across clinical settings. In particular, the optimal route of nutritional support, whether oral feeding, nasogastric tube feeding, or jejunostomy feeding, remains uncertain, especially with respect to anastomotic integrity, pulmonary complications, and other perioperative outcomes. These uncertainties continue to support further investigation of early enteral nutrition in patients undergoing esophageal cancer surgery.

Against this background, we conducted a randomized controlled trial in patients undergoing esophagectomy with reconstruction for esophageal cancer to compare 2 postoperative enteral nutrition strategies delivered via jejunostomy: initiation within 24 hours after surgery and initiation after the first postoperative bowel movement under conventional care. The primary objective was to determine whether earlier enteral feeding improved gastrointestinal functional recovery after esophagectomy. We also performed exploratory analyses of perioperative laboratory parameters, postoperative complications, and other indicators of early postoperative recovery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Esophagectomy
  • Esophagectomy & reconstruction
  • Esophagotomy
  • Esophageal reconstruction-with gastric tube
  • Esophageal reconstruction-with colon
  • Esophageal reconstruction with small intestine

排除标准

  • Gastrointestinal perforation
  • Postoperative hemorrhage
  • Intestinal obstruction

研究组 & 干预措施

Early intestinal force-feeding and drugs to promote gastrointestinal motility

Experimental

干预措施: early feeding (Other)

early enteral feeding

Experimental

干预措施: early feeding (Other)

giving force-feeding after gas or defecation

No Intervention

结局指标

主要结局

gastrointestinal emptying time

时间窗: up to 24 hours (time of the first bowel movement or exhaust after surgery )

Start timing the first bowel movement or exhaust time after surgery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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