An observational study in Colon Adenoma, sponsored by Hospital Universitario de Canarias. Status unknown. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-12.
Sponsored by Hospital Universitario de Canarias · Observational
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.
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.
657 studies on the registry are indexed under Adenoma; 98 are open to participants now.
This study's planned enrollment of 400 is above the median of 300 across 226 observational studies indexed under Adenoma.
Browse Adenoma studies →Hospital Universitario de Canarias is the lead sponsor of 30 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
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.
Also known as: 4 liters of Polyethylene glycol bowel preparation
The validated Boston Bowel Preparation Scale will be used to measure colon cleansing quality
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.
Time frame: 8 months
To design a predictive score of inadequate bowel preparation [Time Frame: 1 years][Designated as safety issue: No]
Variables independently associated with Bowel cleansing with be used to build a predictive score
Time frame: 8 months
No study locations are listed for this record.
Plan to share: No
This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hospital Universitario de Canarias