Patient and Colonoscopy Cleansing Quality Agreement

NCT04702646 | Completed

• 1 other identifier: Colon cleansing agreement
• Study Type: observational
• Target: 1,011
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of the study is to determine the agreement between colon cleansing quality assessed by a validated scale (Boston Bowel Preparation Scale, BBPS) and the perception of the patient. Patients will be prepared with polyethylene glycol (PEG), PEG plus ascorbic acid (PEG-Asc) or sodium picosulfate-oxide magnesium solution (PS). The secondary aim is to assess predictors of poor bowel cleansing.

Conditions

Cleansing Quality of the Colon

Outcome Measures

Primary Outcomes (1)

• Quality of bowel cleansing

  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

  [Time frame: 1 years][Designated as safety issue: No]

Secondary Outcomes (2)

• Predictive factors associated to an adequate bowel cleansing

  [Time Frame: 1 years][Designated as safety issue: No]

• Test the correlation between 3 sets of pictures and the cleansing quality following the Boston Bowel Preparation Scale

  [Time Frame: 6 months][Designated as safety issue: No]

Study Arms (1)

Consecutive patients for outpatient colonoscopy

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

Drug: Bowel preparation before colonoscopy; Procedure: Colonoscopy

Interventions

Bowel preparation before 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 Polyethylene glycol solution, 2 Liters of PEG-Ascorbic acid or 2 Liters Picosulfate.

Consecutive patients for outpatient colonoscopy

Colonoscopy PROCEDURE

colonoscopy will be performed to every patient included in the study

Consecutive patients for outpatient colonoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Age \>18,
• to sign the informed consent
• patients with indication of outpatient colonoscopy
• patient ingesting preparation

You may not qualify if:

• Last colonoscopy with poor bowel preparation.
• Ileus, intestinal obstruction, megacolon.
• Poorly controlled hypertension (systolic hypertension\> 180mmHg, dyastolic hypertension\> 100mmHg).
• 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.
• Not looking at the characteristics of the last stool.

Sponsors & Collaborators

• Hospital Universitario de Canarias: lead

Study Sites (1)

Department of Gastroenterology

San Cristóbal de La Laguna, S/C de Tenerife, 38320, Spain

Location

Related Publications (6)

• Fatima H, Johnson CS, Rex DK. Patients' description of rectal effluent and quality of bowel preparation at colonoscopy. Gastrointest Endosc. 2010 Jun;71(7):1244-1252.e2. doi: 10.1016/j.gie.2009.11.053. Epub 2010 Apr 1.

  PMID: 20362286 BACKGROUND

• Harewood GC, Wright CA, Baron TH. Assessment of patients' perceptions of bowel preparation quality at colonoscopy. Am J Gastroenterol. 2004 May;99(5):839-43. doi: 10.1111/j.1572-0241.2004.04176.x.

  PMID: 15128347 BACKGROUND

• ASGE Technology Committee; Mamula P, Adler DG, Conway JD, Diehl DL, Farraye FA, Kantsevoy SV, Kaul V, Kethu SR, Kwon RS, Rodriguez SA, Tierney WM. Colonoscopy preparation. Gastrointest Endosc. 2009 Jun;69(7):1201-9. doi: 10.1016/j.gie.2009.01.035. No abstract available.

  PMID: 19481646 BACKGROUND

• Hassan C, East J, Radaelli F, Spada C, Benamouzig R, Bisschops R, Bretthauer M, Dekker E, Dinis-Ribeiro M, Ferlitsch M, Fuccio L, Awadie H, Gralnek I, Jover R, Kaminski MF, Pellise M, Triantafyllou K, Vanella G, Mangas-Sanjuan C, Frazzoni L, Van Hooft JE, Dumonceau JM. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2019. Endoscopy. 2019 Aug;51(8):775-794. doi: 10.1055/a-0959-0505. Epub 2019 Jul 11.

  PMID: 31295746 BACKGROUND

• Hassan C, Fuccio L, Bruno M, Pagano N, Spada C, Carrara S, Giordanino C, Rondonotti E, Curcio G, Dulbecco P, Fabbri C, Della Casa D, Maiero S, Simone A, Iacopini F, Feliciangeli G, Manes G, Rinaldi A, Zullo A, Rogai F, Repici A. A predictive model identifies patients most likely to have inadequate bowel preparation for colonoscopy. Clin Gastroenterol Hepatol. 2012 May;10(5):501-6. doi: 10.1016/j.cgh.2011.12.037. Epub 2012 Jan 10.

  PMID: 22239959 BACKGROUND

• Hernandez G, Gimeno-Garcia AZ, Quintero E. Strategies to Improve Inadequate Bowel Preparation for Colonoscopy. Front Med (Lausanne). 2019 Nov 8;6:245. doi: 10.3389/fmed.2019.00245. eCollection 2019.

  PMID: 31781565 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 Garcia, MD, PhD

  Hospital Universitario de Canarias

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2021
• First Posted: January 11, 2021
• Study Start: February 17, 2021
• Primary Completion: May 31, 2021
• Study Completion: September 30, 2021
• Last Updated: September 21, 2022

Record last verified: 2022-09

Locations

ES (1)