Risk Factors of Poor Bowel Cleansing in Inpatients

• ClinicalTrials.gov Identifier: NCT03902561
• Recruitment Status: Not yet recruiting
• First Posted: April 4, 2019
• Last Update Posted: April 12, 2019
• Sponsor: Hospital Universitario de Canarias
• 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.

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 *

• Gimeno-García AZ, Hernandez G, Aldea A, Nicolás-Pérez D, Jiménez A, Carrillo M, Felipe V, Alarcón-Fernández O, Hernandez-Guerra M, Romero R, Alonso I, Gonzalez Y, Adrian Z, Moreno M, Ramos L, Quintero E. Comparison of Two Intensive Bowel Cleansing Regimens in Patients With Previous Poor Bowel Preparation: A Randomized Controlled Study. Am J Gastroenterol. 2017 Jun;112(6):951-958. doi: 10.1038/ajg.2017.53. Epub 2017 Mar 14.
• Gimeno-García AZ, Baute JL, Hernandez G, Morales D, Gonzalez-Pérez CD, Nicolás-Pérez D, Alarcon-Fernández O, Jiménez A, Hernandez-Guerra M, Romero R, Alonso I, Gonzalez Y, Adrian Z, Carrillo M, Ramos L, Quintero E. Risk factors for inadequate bowel preparation: a validated predictive score. Endoscopy. 2017 Jun;49(6):536-543. doi: 10.1055/s-0043-101683. Epub 2017 Mar 10.
• Rotondano G, Rispo A, Bottiglieri ME, De Luca L, Lamanda R, Orsini L, Bruzzese D, Galloro G; SIED Campania PISCoPO study group investigators, Romano M, Miranda A, Loguercio C, Esposito P, Nardone G, Compare D, Magno L, Ruggiero S, Imperatore N, De Palma GD, Gennarelli N, Cuomo R, Passananti V, Cirillo M, Cattaneo D, Bozzi RM, D'Angelo V, Marone P, Riccio E, De Nucci C, Monastra S, Caravelli G, Verde C, Di Giorgio P, Giannattasio F, Capece G, Taranto D, De Seta M, Spinosa G, De Stefano S, Familiari V, Cipolletta L, Bianco MA, Sansone S, Galasso G, De Colibus P, Romano M, Borgheresi P, Ricco G, Martorano M, Gravina AG, Marmo R, Rea M, Maurano A, Labianca O, Colantuoni E, Iuliano D, Trovato C, Fontana A, Pasquale L, Morante A, Perugini B, Scaglione G, Mauro B. Quality of bowel cleansing in hospitalized patients undergoing colonoscopy: A multicentre prospective regional study. Dig Liver Dis. 2015 Aug;47(8):669-74. doi: 10.1016/j.dld.2015.04.013. Epub 2015 Apr 25.
• Yadlapati R, Johnston ER, Gregory DL, Ciolino JD, Cooper A, Keswani RN. Predictors of Inadequate Inpatient Colonoscopy Preparation and Its Association with Hospital Length of Stay and Costs. Dig Dis Sci. 2015 Nov;60(11):3482-90. doi: 10.1007/s10620-015-3761-2. Epub 2015 Jun 21.

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

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