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临床试验/NCT04675606
NCT04675606招募中不适用

A Prospective Randomized Trial of Low Fiber Diet vs. Regular Diet in Postoperative Colorectal Patients With Ileostomies

Cedars-Sinai Medical Center2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2020年10月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
160
试验地点
2
主要终点
Rate of postoperative ileus and obstruction

研究概览

简要总结

The primary objective of this study is to prospectively evaluate rate of post-operative ileus or obstruction in patients with ileostomies receiving low fiber diet vs. regular diet starting post-operative day 1. The secondary objectives of this study are to compare the 30-day and 90-day readmission rates, length of stay, rate of high stoma output or need for antidiarrheals within 90 days, nausea score, level of pain, and overall quality of life amongst the patients studied.

详细描述

The proposed study is a prospective randomized study to compare two post-operative diets

  1. Low fiber diet
  2. Regular diet in patients undergoing elective or urgent colorectal surgery resulting in a loop or end ileostomy. The primary outcome measure is rate of post-operative ileus or obstruction in patients with ileostomies. The secondary objectives of this study are to compare the length of stay, 30-day and 90-day readmission rates, rate of high stoma output requiring antidiarrheal medication, nausea score, pain score, and overall quality of life amongst the patients studied.

All groups will be counseled and asked to consent for the study at the time of their preoperative clinic visit and copy of the protocol will be provided to them. Patients undergoing urgent surgery will be counseled and consented at the time decision for surgery is made. All groups will be started on either low fiber diet or regular diet on postoperative day 1. Of note, it is important to note that at our institution, a "low fiber diet" is equivalent to a "low residue diet" in our electronic medical records system. All groups will be assessed and examined daily, where nausea score and pain score will be recorded. Prior to discharge, both groups will receive consultation with a wound-ostomy care nurse who will perform ostomy teaching as well as diet/nutritional counseling. Patients in the low fiber diet arm will receive nutritional counseling advising that they follow a low fiber diet. Patients in the regular diet arm will receive nutritional counseling advising that they continue to follow a regular diet.

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

入选标准

  • Male or Female
  • Undergoing elective or urgent major laparoscopic or open colorectal procedure resulting in new loop or end ileostomy creation
  • Urgent colorectal surgery is defined as operations performed during the same hospital admission, but greater than 24hrs after decision for surgery is made. Patients undergoing urgent colorectal surgery are not expected to require intensive care unit (ICU) admission postoperatively.
  • Willingness and ability to sign an informed consent document
  • No allergies to anesthetic or antiemetic
  • ASA physical status Class I - III
  • Aged 18-90 years

排除标准

  • Refusal to participate in the study
  • Undergoing emergent colorectal surgery. Emergent colorectal surgery is defined as patients who require immediate surgery < 24hrs after initial decision for surgery is made
  • Patients expected to require intensive care unit (ICU) admission postoperatively
  • Age <18 or > 90 years
  • Patient with preoperative short-bowel syndrome or proximal stomas (jejunostomy)
  • Patients on preoperative total parenteral nutrition not expected to immediately commence postoperative enteral nutrition
  • Patients maintained NPO for any reason after surgery

结局指标

主要结局

Rate of postoperative ileus and obstruction

时间窗: 90 days postoperatively

evaluate rate of post-operative ileus or obstruction in patients with ileostomies receiving low fiber diet vs. regular diet starting post-operative day 1.

次要结局

  • Hospital readmission rates(90 days postoperatively)
  • Average maximum daily nausea score(90 days postoperatively)
  • Average maximum daily pain score(90 days postoperatively)
  • Hospital length of stay(Up to 90 days postoperatively)
  • Volume of stoma output(90 days postoperatively)
  • Need for antidiarrheal use(90 days postoperatively)
  • Quality of life(90 days postoperatively)

研究者

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

Karen Zaghiyan

Associate Professor of Surgery

Cedars-Sinai Medical Center

研究点 (2)

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