Evaluation of The Factors Affecting Bowel Preparation Adequacy for Colonoscopy

Bowel Preparation Clinical Trial

Official title:

Evaluation of The Factors Affecting Bowel Preparation Adequacy for Colonoscopy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05107505
• Other study ID #: Alexandra Bowel Preparation
• Status: Recruiting
• Start date: July 15, 2021
• Est. completion date: July 14, 2023

Study information

• Verified date: February 2022
• Source: Alexandra Hospital, Athens, Greece
• Contact: Spyridon Michopoulos, MD
• Phone: 00302103381387
• Email: michosp5[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A prospective observational study in order to:

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. nd: Evaluation of the effect of the time of preparation and endoscopy initiation time on the outcome of intestinal preparation for colonoscopy.

Description:

Unsuccessful preparation for lower gastrointestinal endoscopy is to date the main obstacle to a comprehensive examination and the main reason for its recurrence. It is also directly related to its diagnostic value.

The literature shows that the diet prior to colonoscopy, the time of assumption of the preparation and certain epidemiological and clinical characteristics of the patient can affect the outcome of the intestinal preparation for colonoscopy.

This seems that adequasy of colonoscopy affects a number of qualitative indicators of lower gastrointestinal endoscopy, such as the duration, the catheterization of the fundus of the cecum and the number of polyps found.

This is a prospective observational study in order to:

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. nd: Evaluation of the effect of the time of preparation and endoscopy initiation time on the outcome of intestinal preparation for colonoscopy.

With starting date:01/07/2021 and expiration date:30/06/2022 (duration: 12 months). All patients who come to the Gastroenterology Department of Alexandra Hospital for endoscopy of the lower digestive tract are eligible for the research protocol. Patients younger than 18 years old or patients who refuse to participate are excluded.

The study has 3 phases. Phase 0 entails the completion of a questionnaire that will include epidemiological, clinical and preparation-related data in all patients who undergoing colonoscopy at the Endoscopy Department. Phase I incorporates Completion of data related to the time of the examination, the result of the preparation (Boston Bowel Preparation Scale) as well as the findings of the endoscopic examination and phase II includes the statistical analysis of the data.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: July 14, 2023
• Est. primary completion date: July 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients undergoing colonoscopy:

• Age > 18 years

• Have been prepared for lower gastrointestinal endoscopy

• Have agreed to participate in the study

Exclusion Criteria:

• Age <18 years

• Non-acceptance of participation in the study

Related Conditions & MeSH terms

• Bowel Preparation
• Preparation for Colonoscopy

Locations

Country	Name	City	State
Greece	Alexandra General Hospital	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Alexandra Hospital, Athens, Greece

Country where clinical trial is conducted

Greece, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	quality of preparation for colonoscopy	Evaluation of the effect of the time of preparation and endoscopy initiation time on the outcome of intestinal preparation for colonoscopy	01/07/2021-30/06/2022