One time colonoscopy in inpatients in Colon Adenoma - Clinical Trials Registry

Study Overview

Status

Unknown

Conditions

Colon Adenoma

Intervention / Treatment

Device: one time colonoscopy in inpatients

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

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario de Canarias

Investigators

Principal Investigator: Antonio Z Gimeno García, MD, PhD, Hospital Universitario de Canarias

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2019

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

February 1, 2020

Study Registration Dates

First Submitted

April 2, 2019

First Submitted That Met QC Criteria