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临床试验/NCT04702646
NCT04702646已完成不适用

Agreement Between Cleansing Quality Assessment During Colonoscopy and Patient Reported Cleansing Quality

Hospital Universitario de Canarias1 个研究点 分布在 1 个国家目标入组 1,011 人开始时间: 2021年2月17日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
1,011
试验地点
1
主要终点
Quality of bowel cleansing

研究概览

简要总结

The main purpose of the study is to determine the agreement between colon cleansing quality assessed by a validated scale (Boston Bowel Preparation Scale, BBPS) and the perception of the patient. Patients will be prepared with polyethylene glycol (PEG), PEG plus ascorbic acid (PEG-Asc) or sodium picosulfate-oxide magnesium solution (PS).

The secondary aim is to assess predictors of poor bowel cleansing.

详细描述

Although, current guidelines recommend a rate of inadequate bowel cleansing for colonoscopy not higher than 10-15%, in clinical practice poor bowel cleansing in endoscopy units ranged between 6.8% and 33 The patient's perception of their colon cleansing before colonoscopy has been stated as a predictor of cleansing quality in a limited number of studies. In such a way, if the agreement between the patient's reported colon cleansing and the quality during colonoscopy is optimal, rescue cleansing strategies such as the administration of additional bowel solution might be indicated. In the studies that assessed the relationship between patient and colonoscopy assessment of colon cleansing quality the agreement was fair. The main drawback of these studies is that they do not used a validated colonoscopy cleansing scale.

Therefore, ideally, patient-referred information regarding the quality of colon cleaning could be a factor of great value in guiding rescue strategies. However, the available evidence of the correlation between the patient's perception of the quality of colon cleansing at the time of colonoscopy is scarce and has also not been adequately studied. Evaluating this correlation in a cohort of unselected patients referred for outpatient colonoscopy and using a universally accepted validated colon cleansing quality scale could help to determine whether this system is a good predictor of inadequate colon cleansing and can guide the implementation of rescue strategies.

The researchers will offer to participate in the study to patients scheduled for a colonoscopy who meet all the inclusion criteria and none of the exclusion criteria. The researchers will explain the purpose of the study and will ask to sign the informed consent. They will give verbal and written information. Patients will fill out a questionnaire on the day of colonoscopy on the perception of cleanliness based on the last stool. To do this, a set with 4 figures (light liquid, light liquid with lumps, dark liquid or solid particles) used in a previous study will be shown to the patient and the patient should indicate which figure is more similar to the last bowel movement. Optionally, the patient will be able to provide the investigating staff with a photo of their last deposition. Patients should also note the hour of the last stool. Four researchers will chose the set considered more appropriate for the study.

In addition, three sets compound of 4 pictures of different cleansing qualities will be presented to a subgroup of patients to test which one is more similar to the last stool.

Subsequently, the colonoscopy will be performed and the cleaning quality will be scored according to the BBPS considering suboptimal a cleaning quality of less than 2 points in a segment of the colon. Patients will receive any of the routinely used colonic preparations in the hospital, i.e. Casenglycol® (polyethylene glycol), Moviprep® (polyethylene glycol and ascorbic acid) and Citrafleet® (picosulfate sodium, light magnesium oxide, citric acid).The bowel cleansing quality following BBPS will be assessed by the endoscopist.

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

  • Age >18,
  • to sign the informed consent
  • patients with indication of outpatient colonoscopy
  • patient ingesting preparation

排除标准

  • Last colonoscopy with poor bowel preparation.
  • Ileus, intestinal obstruction, megacolon.
  • Poorly controlled hypertension (systolic hypertension> 180mmHg, dyastolic hypertension> 100mmHg).
  • Terminal renal failure (pre-dialysis or dialysis).
  • Congestive heart failure (NYHA III-IV).
  • Acute liver failure.
  • Severe psychiatric illness.
  • Dementia with difficulty in the intake of the preparation.
  • Pregnancy or breastfeeding.
  • Refusal to participate in the study.
  • Allergies.
  • Not looking at the characteristics of the last stool.

研究组 & 干预措施

Consecutive patients for outpatient colonoscopy

The researchers will offer to participate in the study to patients scheduled for a colonoscopy who meet all the inclusion criteria and none of the exclusion criteria

干预措施: Bowel preparation before colonoscopy (Drug)

Consecutive patients for outpatient colonoscopy

The researchers will offer to participate in the study to patients scheduled for a colonoscopy who meet all the inclusion criteria and none of the exclusion criteria

干预措施: Colonoscopy (Procedure)

结局指标

主要结局

Quality of bowel cleansing

时间窗: [Time frame: 1 years][Designated as safety issue: No]

Quality of bowel cleansing assessed by the Boston Bowel Preparation Scale. This scale goes from 0 (no preparation) to 3 points (excellent preparation) in the three segments of the colon (proximal, transverse and distal). The maximum score is 9 points

次要结局

  • Predictive factors associated to an adequate bowel cleansing([Time Frame: 1 years][Designated as safety issue: No])
  • Test the correlation between 3 sets of pictures and the cleansing quality following the Boston Bowel Preparation Scale([Time Frame: 6 months][Designated as safety issue: No])

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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