Risk Factors of Poor Bowel Cleansing in Inpatients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03902561|
Recruitment Status : Not yet recruiting
First Posted : April 4, 2019
Last Update Posted : April 12, 2019
|Condition or disease||Intervention/treatment|
|Colon Adenoma||Device: one time colonoscopy in inpatients|
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|
|Estimated Enrollment :||400 participants|
|Official Title:||Risk Factors of Inadequate Bowel Cleansing in Inpatients: a Predictive Score|
|Estimated Study Start Date :||April 2019|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||February 2020|
- 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
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03902561
|Contact: Antonio Z Gimeno García, MD, PhD||922678000 ext firstname.lastname@example.org|
|Principal Investigator:||Antonio Z Gimeno Garcia, MD, PhD||Hospital Universitario de Canarias|