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临床试验/NCT02264249
NCT02264249已完成不适用

Residual Gastric Volume in Same Day Versus Split Dose and Evening Before Bowel Preparation: A Prospective Observational Study

The Cleveland Clinic1 个研究点 分布在 1 个国家目标入组 449 人开始时间: 2014年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
449
试验地点
1
主要终点
Residual Gastric Volumes of Different Bowel Preparation Regimens

研究概览

简要总结

The purpose of this study is to determine residual gastric volume and residual gastric pH in patients undergoing combined EGD and colonoscopy comparing the standard single dose prep with the split dose bowel preparation and same day bowel preparations.

详细描述

The ASGE and ACG have developed standards for high-quality colonoscopy and ADR. Bowel cleansing must be optimal to enhance polyp detection and several studies have demonstrated the advantage of split dose or same day preparation as opposed to ingesting the preparation the day before. It is recommended that patients undergo split dosing of the bowel preparation or even same day bowel preparation for optimal cleansing. This is critical for high quality colonoscopy.

One of the risks associated with colonoscopy is pulmonary aspiration. Part of this risk may be related to retained gastric volume and gastric pH at the time of the endoscopic procedures. Aspiration pneumonia may be related to the acidity where more acidic aspirate may cause more severe respiratory compromise. In a recent article, Huffman supported the safety of split dose bowel preparation (4L bowel preparation) for outpatients undergoing colonoscopy. In this study it was/found that residual gastric volume in split dose preparations was higher than patients undergoing EGD alone but was not different from than in patients receiving bowel preparation the evening before. Early morning bowel preps for patients undergoing upper and lower endoscopies was not evaluated in this study. To our knowledge, the relationship of residual gastric volume in same day bowel preps has not been evaluated and has not been compared with the split dose bowel preps. A formal evaluation of difference in gastric acidity has not been evaluated in patients undergoing bowel prep for colonoscopy.

The study has a prospective observational design. The patients who have been already scheduled for a combined esophagogastroduodenoscopy and colonoscopy for their specific indications will be asked to be a part of this study. No additional intervention will be done other than the procedure they were already scheduled for. No specific interventions will be assigned to the subjects of the study. Outcomes will be assessed in pre-defined groups based on the bowel preparation taken by the patient.

The fluid is going to be collected in a suction container without solidifier material. Once the endoscopist enters the stomach all fluid will be suctioned which is part of the customary process of endoscopy. Once all fluid is aspirated, the container will be removed to empty the fluid into a measuring canister while the endoscopic procedure is continued and a container with solidifier material is instead connected to suction. The pH will be measured on the gastric fluid that was aspirated using a calibrated catheter pH device.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Adult patients (ages 18 and over) scheduled for elective non-emergency outpatient combined Esophagogastroduodenoscopy and colonoscopy procedures at CCF. No additional intervention will be done other than the procedure they were scheduled for.

排除标准

  • Upper GI or lower GI bleeding at the time of procedure
  • Large amounts of vomiting reported before the procedure (with bowel preparation)
  • Hospital inpatients
  • History of abdominal surgery
  • History of gastroparesis or other documented GI transit disorder (ex. Colonic inertia)
  • Pregnancy Patients with diabetes mellitus taking Metoclopramide without proven gastroparesis by formal testing will not be excluded.

结局指标

主要结局

Residual Gastric Volumes of Different Bowel Preparation Regimens

时间窗: 1 day

The residual gastric volume for the patients undergoing a combined esophagogastroduodenoscopy and colonoscopy will be measured and compared among the groups taking different bowel preparations.

次要结局

  • Procedure Complications (Decrease in Oxygen Saturation)(1 day)
  • pH of Gastric Fluid of Different Bowel Preparation Regimens(1 day)

研究者

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

Alison Schneider

Staff Physician

The Cleveland Clinic

研究点 (1)

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