Predictive Models of Inadequate Colonic Preparation

Cleansing Quality of the Colon Clinical Trial

— Quality  

Official title:

Comparative Study of Predictive Models of Inadequate Colonic Preparation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05871801
• Other study ID #: CHUC_2022_87
• Status: Recruiting
• Start date: May 20, 2023
• Est. completion date: September 1, 2023

Study information

• Verified date: June 2023
• Source: University of La Laguna
• Contact: Antonio Z Gimeno García, MD, PhD
• Phone: +34922678554
• Email: antozeben[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: September 1, 2023
• Est. primary completion date: August 20, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cleansing Quality of the Colon

Intervention

Drug:
• Bowel preparation for colonoscopy
one day liquid diet will be administered to every patient included in the study and: split-dose bowel preparation with 4 Liters of Polyethylenglycol (PEG) solution, 2 Liters of PEG-Asccorbic acid or 2L sodium picosulphate.

Device:
• Colonoscopic examination
Colonoscopy will be performed to every patient included in the study

Locations

Country	Name	City	State
Spain	Hospital Universitario de Canarias	La Laguna	Santa Cruz De Tenerife

Sponsors (1)

Lead Sponsor	Collaborator
Manuel Hernandez-Guerra, MD

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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