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Risk Factors of Poor Bowel Cleansing in Inpatients

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ClinicalTrials.gov Identifier: NCT03902561
Recruitment Status : Not yet recruiting
First Posted : April 4, 2019
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
Hospital Universitario de Canarias

Tracking Information
First Submitted Date April 2, 2019
First Posted Date April 4, 2019
Last Update Posted Date April 12, 2019
Estimated Study Start Date April 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 4, 2019)
The validated Boston Bowel Preparation Scale will be used to measure colon cleansing quality [ Time Frame: 8 months ]
The Boston Bowel Preparation Scale scores cleansing quality from 0 to 3 points per segment (distal colon, transverse colon and right colon). The maximum score is 9 and the lowest 0. A score equal or more than 2 points per segment is considered an adequate preparation for this segment.
Original Primary Outcome Measures
 (submitted: April 2, 2019)
Quality of bowel cleansing assessed by the validated Boston Bowel Predictive Scale [ Time Frame: 8 months ]
The endoscopist will use a validated cleansing scale scoring colon quality from 0 to 9 points.
Change History
Current Secondary Outcome Measures
 (submitted: April 2, 2019)
To design a predictive score of inadequate bowel preparation [Time Frame: 1 years][Designated as safety issue: No] [ Time Frame: 8 months ]
Variables independently associated with Bowel cleansing with be used to build a predictive score
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Risk Factors of Poor Bowel Cleansing in Inpatients
Official Title Risk Factors of Inadequate Bowel Cleansing in Inpatients: a Predictive Score
Brief Summary The main purpose of the study is to determine risk factors of poor bowel cleansing in inpatients after a split-dose high volume preparation with 4 liters of polyethylene glycol. The quality of colon cleansing will be measured by the Boston bowel cleansing scale (more than or equal to 2 points in each segment). The secondary aim is to design a predictive score of poor bowel cleansing.
Detailed Description

It is well-known that inpatient status is a risk factor of inadequate bowel preparation. However this is a very mixed group, coexisting multiple factors containing several risk factors, such as elderly, comorbidities, a variety of medications, physical inactivity… Predictive factors in this population are probably different to those identified in outpatients. There is no strong evidence about the influence of these factors on inpatient bowel cleansing.

The researchers will offer to participate in the study to inpatients scheduled for 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 on the diet and the bowel cleansing solution to be taken. A questionnaire will be administered about predictors of inadequate bowel cleansing. Activity will be measured by using a pedometer and a physical performance test.

Patients will take a liquid diet the day before the examination and they will be prepared with 4 liters of polyethylene glycol in split-dose regimen: 2 liters the evening before the examination (at 19.00 hours) and 2 liters 5 hours before colonoscopy The bowel cleansing quality following Boston Bowel Preparation Scale will be assessed by the endoscopist during the colonoscopy.

The aim of this study is to figure out the risk factors of bowel cleansing of inadequate bowel preparation in inpatients.

The inclusion of a maximum of 10 variables in the multivariate analysis will be considered: age, sex, short test of physical performance, Charlson index, indication (urgent or scheduled), polymedication (≥ 5 drugs), exposure to tricyclic antidepressants, calcium antagonists or opioids, constipation (<3 deposits per week and one of the following defecatory efforts), number of steps. For a predetermined percentage of 25% of patients with inadequate preparation, the inclusion of 400 inpatients who undergo a colonoscopy will be required. If we estimate an inclusion of about 10 patients per week, an inclusion period of about 10 months would be required.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population

The researchers will offer to participate in the study to inpatients scheduled for 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 on the diet and the bowel cleansing solution to be taken. A questionnaire will be administered about predictors of inadequate bowel cleansing. Activity will be measured by using a pedometer and a physical performance test.

Patients will take a liquid diet the day before the examination and they will be prepared with 4 liters of polyethylene glycol in split-dose regimen: 2 liters the evening before the examination (at 19.00 hours) and 2 liters 5 hours before colonoscopy

Condition Colon Adenoma
Intervention Device: one time colonoscopy in inpatients
All the inpatients with indication of colonoscopy will be prepared with 4 liters polyethylene glycol bowel cleansing prior to colonoscopy. Colonoscopy will be performed as regular practice under conscious sedation.
Other Name: 4 liters of Polyethylene glycol bowel preparation
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: April 2, 2019)
400
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Inpatients with an indication of a colonoscopy
  • Age ≥ 18 years.

Exclusion Criteria:

  • Patients with previous colon surgery
  • Last colonoscopy with poor bowel preparation.
  • Ileus, intestinal obstruction, megacolon.
  • Poorly controlled hypertension (Systolic and diastolic blood pressure > 180 and > 100, respectively).
  • Terminal renal failure (pre-dialysis or dialysis).
  • Congestive heart failure (NYHA III-IV).
  • Acute liver failure.
  • Severe psychiatric illness.
  • Pregnancy or breastfeeding.
  • Refusal to participate in the study.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Antonio Z Gimeno García, MD, PhD 922678000 ext 8039 antozeben@gmail.com
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03902561
Other Study ID Numbers ANT-POL-2017-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Hospital Universitario de Canarias
Study Sponsor Hospital Universitario de Canarias
Collaborators Not Provided
Investigators
Principal Investigator: Antonio Z Gimeno Garcia, MD, PhD Hospital Universitario de Canarias
PRS Account Hospital Universitario de Canarias
Verification Date April 2019