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临床试验/NCT05167890
NCT05167890Unknown不适用

Impact of Standardized Coffee Versus Orange Juice Intake on Enhancing Bowel Movements After Elective Laparoscopic Colorectal Surgery, RCT

National Cancer Institute, Egypt1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年11月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
1
主要终点
Primary end point is time to first bowel movement (flatus or stool) starting at the time of surgery completion.

研究概览

简要总结

Colorectal surgery, even performed by laparoscopy is followed by a transient episode of GI hypomotility, which results in a postoperative ileus (POI). The usual duration of this benign postoperative situation varies between 3 and 5 days for colon surgery. A longer duration of POI will result in more postoperative complications such as delayed surgical wound healing, atelectasis, pneumonia, and deep vein thrombosis; in a prolonged hospital stay; and increased healthcare cost. Different studies reported that the duration of POI correlates with total surgery time, blood loss, total opiate dose degree of surgical trauma, and bowel manipulation. Many attempts have been made to reduce the phase of postoperative intestinal hypomotility. The different strategies are well described in enhanced recovery and fast-track concepts and focus on minimal surgical trauma, rapid postoperative mobilization, early feeding, preemotive laxative treatment, restrictive fluid management, and minimal postoperative opioid prescription. Furthermore, several pharmacologic agents have been evaluated; however, not all offered a convincing benefit, nor were they free of adverse effects. Coffee is a worldwide highly consumed beverage, offering pleasure to many people of different cultures, and which many associate with an increase of bowel function.

The aim of this study is to compare the time to first bowel movement after laparoscopic colorectal surgery between patients drinking coffee or orange juice postoperatively, in a randomized controlled trial (RCT).

详细描述

The study is designed as a multi-center, open-label RCT. All of the eligible patients undergoing elective laparoscopic colon or rectal resection are considered for participation in the study unless exclusion criteria are present. Written informed consent is obtained after hospital admission.

Patients will be classified into two groups:

  1. Coffee Arm: receiving coffee (Turkish sugar free coffee).
  2. Orange Arm: receiving orange juice (fresh sugar free). Baseline demographics, peri-operative data (HB, serum Alb and electrolytes), duration of operation, conversion rate to open surgery, estimated blood loss, short-term outcome, and LOS (length of hospital stay) will be analyzed.

Exclusion criteria:

Creation of a colostomy or ileostomy, Any additional small bowel anastomosis, Emergency operations, known hypersensitivity or allergy to coffee or orange.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •patients undergoing elective laparoscopic colon or rectal resection

排除标准

  • •Creation of a colostomy or ileostomy,
  • •Any additional small bowel anastomosis,
  • •Emergency operations,
  • •known hypersensitivity or allergy to coffee or orange.

研究组 & 干预措施

Orange Arm

Active Comparator

Patients in orange arm receive 1 cup of orange juice 3 times per day (150 mL at 8:00 AM, 12:00 PM, and5:00 PM), in addition to the regular infusion therapy and/or alimentation starting the first day postoperatively till the end of the 3 postoperative day.

干预措施: Orange juice (Dietary Supplement)

Coffee Arm

Active Comparator

Patients in coffee arm receive 1 cup of coffee 3 times per day (150 mL at 8:00 AM, 12:00 PM, and5:00 PM), in addition to the regular infusion therapy and/or alimentation starting the first day postoperatively till the end of the 3 postoperative day.

干预措施: Coffee (Dietary Supplement)

结局指标

主要结局

Primary end point is time to first bowel movement (flatus or stool) starting at the time of surgery completion.

时间窗: From day of surgery to-day of hospital discharge (up to 2 weeks)

Included patients are given a diary and are asked (after instruction) to document on a daily basis if they had defecation or flatus and what time; this was verified 3 times per day by the nurse.

次要结局

未报告次要终点

研究者

发起方
National Cancer Institute, Egypt
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yasser Debakey

Lecturer of surgical oncology, NCI, Cairo University

National Cancer Institute, Egypt

研究点 (1)

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