Predictive Models of Inadequate Colonic Preparation

NCT05871801 | Completed

• 1 other identifier: CHUC_2022_87
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Cleansing Quality of the Colon

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of predictive factors of poor bowel cleansing

  3 months

Interventions

Bowel preparation for colonoscopy DRUG

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.

Colonoscopic examination DEVICE

Colonoscopy will be performed to every patient included in the study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Manuel Hernandez-Guerra, MD: lead

Study Sites (1)

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain

Location

Related Publications (3)

• 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.

  PMID: 25600879 BACKGROUND

• 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.

  PMID: 33852957 BACKGROUND

• 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.

  PMID: 28282690 BACKGROUND

MeSH Terms

Interventions

Colonoscopy

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Antonio Z Gimeno García, MD, PhD

  Hospital Universitario de Canarias

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 13, 2023
• First Posted: May 23, 2023
• Study Start: May 20, 2023
• Primary Completion: August 20, 2023
• Study Completion: September 1, 2023
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)