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临床试验/NCT06737211
NCT06737211已完成不适用

Optimizing Postoperative Nutrition in Colorectal Surgery: a Prospective Randomized Clinical Trial.

National and Kapodistrian University of Athens1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年12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
200
试验地点
1
主要终点
Postoperative Surgical Stress and Short-term Nutritional Status

研究概览

简要总结

Major surgical operations of the gastrointestinal tract, such as colorectal resections due to several diseases, lead to significant burden on the human body, which is expressed during the first postoperative hours with an intense inflammatory reaction and consumption of a large amount of energy, increasing nutritional requirements of the patients. Therefore, specific protocols have been implemented for the early initiation of oral feeding in patients undergoing colorectal resections. However, it is not feasible for every patient to meet them due to several reasons, such as old age and associated pathophysiological changes, use of opioid drugs for the management of postoperative pain, which is associated with postoperative ileus or nausea, as well as open resection which lead to gastrointestinal impairment during the first postoperative days. The energy deficit that occurs during the early postoperative period, which appears to be associated with adverse clinical outcomes, can be counterbalanced by the administration of parenteral nutrition. However, the conventional way of administration through central venous lines is associated with significant complications. For this reason, administration of parenteral nutrition through a peripheral venous catheter could be used alternatively, which avoids morbidity and has been also effective in maintaining the patients' energy balance, even during the first postoperative hours. Therefore, the main purpose of the present study is to investigate the efficacy of the administration of peripheral parenteral nutrition on the postoperative outcomes of patients undergoing colorectal resections. Moreover, the correlation of the administration of peripheral parenteral nutrition with the reaction to post-operative stress and with the nutritional status of the patients post-operatively, which are determining factors for the clinical course of these patients, will be investigated.

研究设计

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

入排标准

年龄范围
18 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Colorectal resection surgery
  • Open or laparoscopic procedures
  • Anastomosis, end-stoma or defunctioning stoma formation after colorectal resection
  • Elective or emergent procedures
  • Diagnosis of colorectal cancer, inflammatory bowel disease, diverticular disease and bowel ischemia
  • Small bowel resection combined with colorectal resection
  • Age > 18 years old
  • Informed consent

排除标准

  • Small bowel resection without colorectal resection
  • End-stoma or defunctioning stoma formation without colorectal resection
  • Preoperative parenteral nutrition administration
  • Administration of parenteral nutrition after the 4th postoperative day
  • Peripheral parenteral nutrition initiation after the 1st postoperative day
  • Contraindication for peripheral parenteral nutrition administration
  • Age < 18 years old
  • No informed consent

研究组 & 干预措施

Intervention

Experimental

2000 mL of peripheral parenteral nutrition with electrolytes (20 mL 7.45% KCl, 10 mL 20% MgSO4 and 20 mL 8.7% Na3PO4) will be administered via a peripheral venous catheter with a rhythm of 80cc/h from the time they will leave the operation room and will be transferred to the ward or the critical care unit (CCU) until the 5th postoperative day

干预措施: Peripheral Parenteral Nutrition (Dietary Supplement)

Control

No Intervention

1000 mL of 10% glucose saline with electrolytes (20 mL 7.45% KCl, 10 mL 20% MgSO4 and 20 mL 8.7% Na3PO4) will be administered via a central or peripheral venous catheter with a rhythm of 80cc/h until the 5th postoperative day

结局指标

主要结局

Postoperative Surgical Stress and Short-term Nutritional Status

时间窗: 5 postoperative days

Serum nutritional markers and acute phase proteins indicating postoperative surgical stress response.

次要结局

  • Postoperative Morbidity(90 postoperative days)
  • Nasogastric tube removal(30 postoperative days)
  • Feeding start(30 postoperative days)
  • Early mobilization(30 postoperative days)
  • Opioid sparing analgesia(30 postoperative days)
  • Peripheral Parenteral Nutrition - associated complications(30 postoperative days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maximos Frountzas

Principal Investigator

National and Kapodistrian University of Athens

研究点 (1)

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