Predictive Models of Inadequate Colonic Preparation (Quality)

Comparative Study of Predictive Models of Inadequate Colonic Preparation

The main purpose of the study is to evaluate in a prospective cohort of patients with an appointment for the performance of an outpatient colonoscopy the prediction of the quality of colonic cleansing through the use of 3 predictive models.

The colon cleansing quality will be assessed by a validated scale (Boston Bowel Preparation Scale, BBPS). Patients will be prepared with polyethylene glycol (PEG), PEG plus ascorbic acid (PEG-Asc) or sodium picosulfate-oxide magnesium solution (PS).

Study Overview

• Status: Recruiting
• Conditions: Cleansing Quality of the Colon
• Intervention / Treatment: Drug: Bowel preparation for colonoscopy; Device: Colonoscopic examination

Detailed Description

Although, current guidelines recommend a rate of inadequate bowel cleansing for colonoscopy not higher than 10-15%, in clinical practice poor bowel cleansing in endoscopy units ranged between 6.8% and 33%. The determinants of poor cleanliness have been evaluated in different studies and can be classified into patient-dependent predictors, which include demographic, socioeconomic and clinical variables, variables dependent on the preparation protocol, including the assigned diet, the type of preparation, its fractionation and the space of time elapsed between the last intake and the colonoscopy, and the tolerance mainly attributed to the volume and taste of the evacuating preparation The American Association of Gastrointestinal Endoscopy recommends the administration of additional preparation to these patients with a higher probability of inadequate preparation. Once non-compliance and lack of tolerance to cleaning protocols are excluded, the reason for inadequate preparation is usually the lack of effectiveness of the cleaning protocol. Therefore, it is advisable to select patients who can benefit from supplemented cleaning preparation or intensified cleaning protocols.

There are so far 4 published predictive models that incorporate clinical variables with the aim of determining patients who are candidates for intensified preparations. Of the models mentioned in the previous studies, only 3 are clearly detailed in the corresponding articles.

The researchers will offer to participate in the study to patients scheduled for a 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.

Subsequently, the colonoscopy will be performed and the cleaning quality will be scored according to the BBPS considering suboptimal a cleaning quality of less than 2 points in a segment of the colon.

The bowel cleansing quality following BBPS will be assessed by the endoscopist

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Antonio Z Gimeno García, MD, PhD; Phone Number: +34922678554; Email: antozeben@gmail.com

Study Locations

• Spain
  • Santa Cruz De Tenerife
    • La Laguna, Santa Cruz De Tenerife, Spain, 38320
      • Recruiting
      • Hospital Universitario de Canarias
      • Contact: Antonio Z Gimeno García, MD, PhD; Phone Number: +34922678554; Email: antozeben@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

The researchers will offer to participate in the study to outpatients scheduled for a 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.

Description

Inclusion Criteria:

• Age >18
• To sign the informed consent,
• Patients with indication of outpatient colonoscopy
• Patients ingesting preparation

Exclusion Criteria:

• Resection of more than one colon segment.
• Ileus, intestinal obstruction, megacolon.
• Poorly controlled hypertension (HTAS> 180 HTAD> 100).
• Terminal renal failure (pre-dialysis or dialysis).
• Congestive heart failure (NYHA III-IV).
• Acute liver failure.
• Severe psychiatric illness.
• Dementia with difficulty in the intake of the preparation.
• Pregnancy or breastfeeding.
• Refusal to participate in the study.
• Allergies.
• Incomplete colonoscopy except for poor bowel cleansing

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of poor bowel cleansing assessed by the Boston Bowel Preparation Scale	Quality of bowel cleansing assessed by the Boston Bowel Preparation Scale. This scale goes from 0 (no preparation) to 3 points (excellent preparation) in the three segments of the colon (proximal, transverse and distal). The maximum score is 9 points	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of predictive factors of poor bowel cleansing	To evaluate the factors associated with inadequate colonic cleaning in this cohort of patients with the aim of improving the models described above	3 months

Collaborators and Investigators

• Sponsor: Manuel Hernandez-Guerra, MD
• Investigators: Principal Investigator: Antonio Z Gimeno García, MD, PhD, Hospital Universitario de Canarias

Publications and helpful links

General Publications

• Dik VK, Moons LM, Huyuk M, van der Schaar P, de Vos Tot Nederveen Cappel WH, Ter Borg PC, Meijssen MA, Ouwendijk RJ, Le Fevre DM, Stouten M, van der Galien O, Hiemstra TJ, Monkelbaan JF, van Oijen MG, Siersema PD; Colonoscopy Quality Initiative. Predicting inadequate bowel preparation for colonoscopy in participants receiving split-dose bowel preparation: development and validation of a prediction score. Gastrointest Endosc. 2015 Mar;81(3):665-72. doi: 10.1016/j.gie.2014.09.066. Epub 2015 Jan 17.
• Gimeno-Garcia AZ, Baute JL, Hernandez G, Morales D, Gonzalez-Perez CD, Nicolas-Perez D, Alarcon-Fernandez O, Jimenez 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.
• Berger A, Cesbron-Metivier E, Bertrais S, Olivier A, Becq A, Boursier J, Lannes A, Luet D, Pateu E, Dib N, Caroli-Bosc FX, Vitellius C, Cales P. A predictive score of inadequate bowel preparation based on a self-administered questionnaire: PREPA-CO. Clin Res Hepatol Gastroenterol. 2021 Jul;45(4):101693. doi: 10.1016/j.clinre.2021.101693. Epub 2021 Apr 20.

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2023
• Primary Completion (Estimated): August 20, 2023
• Study Completion (Estimated): September 1, 2023

Study Registration Dates

• First Submitted: May 13, 2023
• First Submitted That Met QC Criteria: May 13, 2023
• First Posted (Actual): May 23, 2023

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 12, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CHUC_2022_87

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will no be available to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No