NCT05107505

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 4, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2023

Completed
Last Updated

March 3, 2022

Status Verified

February 1, 2022

Enrollment Period

12 months

First QC Date

October 26, 2021

Last Update Submit

February 15, 2022

Conditions

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

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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: 19136102BACKGROUND
  • 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: 23335011BACKGROUND
  • 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: 32377915BACKGROUND

Central Study Contacts

Spyridon Michopoulos, MD

CONTACT

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

Study Start

July 15, 2021

Primary Completion

July 14, 2022

Study Completion

July 14, 2023

Last Updated

March 3, 2022

Record last verified: 2022-02

Locations