Evaluation of The Factors Affecting Bowel Preparation Adequacy for Colonoscopy

NCT05107505 | Unknown

• 1 other identifier: Alexandra Bowel Preparation
• Study Type: observational
• Estimated enrollment: 1,000
• Locations: 1 country
• Sites: 1
• Actual (reported): Study Start
• Estimated — date passed: Primary Completion
• Estimated — date passed: Study Completion

Brief Summary

A prospective observational study in order to:

1. 1.st: Identify epidemiological, clinical, and preparation-related factors that can predict improper preparation leading to better management of the patients with non adequate preparation.
2. 2.nd: Evaluation of the effect of the time of preparation and endoscopy initiation time on the outcome of intestinal preparation for colonoscopy.

Conditions

Bowel Preparation; Preparation for Colonoscopy

Outcome Measures

Primary Outcomes (1)

• improper bowel preparation

  Identify epidemiological, clinical, and preparation-related factors that can predict improper preparation leading to better management of the patients with non adequate preparation.

  01/07/2021-30/06/2022

Secondary Outcomes (1)

• quality of preparation for colonoscopy

  01/07/2021-30/06/2022

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1000 adult patients undergoing colonoscopy

You may qualify if:

• Patients undergoing colonoscopy:
• Age \> 18 years
• Have been prepared for lower gastrointestinal endoscopy
• Have agreed to participate in the study

You may not qualify if:

• Age \<18 years
• Non-acceptance of participation in the study

Sponsors & Collaborators

• Alexandra Hospital, Athens, Greece: lead

Study Sites (1)

Alexandra General Hospital

Athens, 11528, Greece

RECRUITING

Related Publications (3)

• Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):620-5. doi: 10.1016/j.gie.2008.05.057. Epub 2009 Jan 10.

  PMID: 19136102 BACKGROUND

• Hassan C, Bretthauer M, Kaminski MF, Polkowski M, Rembacken B, Saunders B, Benamouzig R, Holme O, Green S, Kuiper T, Marmo R, Omar M, Petruzziello L, Spada C, Zullo A, Dumonceau JM; European Society of Gastrointestinal Endoscopy. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy. 2013;45(2):142-50. doi: 10.1055/s-0032-1326186. Epub 2013 Jan 18.

  PMID: 23335011 BACKGROUND

• Millien VO, Mansour NM. Bowel Preparation for Colonoscopy in 2020: A Look at the Past, Present, and Future. Curr Gastroenterol Rep. 2020 May 6;22(6):28. doi: 10.1007/s11894-020-00764-4.

  PMID: 32377915 BACKGROUND

Central Study Contacts

Spyridon Michopoulos, MD

CONTACT

00302103381387; michosp5@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Of The Gastroenterology Departement

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 4, 2021
• Last Updated: March 3, 2022

Study Start

July 15, 2021

Actual (reported)

Primary Completion

July 14, 2022

Estimated — date passed

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

July 14, 2023

Estimated — date passed

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Record last verified: 2022-02

Locations

GR (1)