NCT07355777

Brief Summary

Colonoscopy which is the standard examination for the exploration of the colon and rectum is performed very frequently. Colon preparation before the examination is an essential step and pescription of the colonic preparation is carried out by the gastroenterologist. However, despite a standardized explanation of the colon preparation, there is heterogeneity in understanding the colonic preparation, which in some cases compromises the quality of the colonoscopy examination. This clinical study aims to investigate whether an explanation of colonic preparation by tutorial films would increase the quality of colon preparation and would reach the recommendations of the Société française d'endoscopie digestive (SFED) in 2019.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
574

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2025

Geographic Reach
1 country

5 active sites

Status
recruiting

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

April 1, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 21, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

12 months

First QC Date

September 29, 2025

Last Update Submit

January 13, 2026

Conditions

Keywords

colon preparationcolonoscopygastro-intestinal disordertutorial

Outcome Measures

Primary Outcomes (1)

  • Assessment of the quality of the colonic preparation by the boston score for each groupe

    To date, the evaluation of the quality of the colonic preparation recognized by the SFED is the establishment of the Boston score. For each group, calculate the percentage of patients obtaining a Boston score ≥ 7. A Boston score ≥ 7 for a high-quality preparation is the score to be obtained according to the 2019 SFED recommendations for at least 90% of patients, excluding colonoscopies performed for emergencies.

    During the colonoscopy procedure

Secondary Outcomes (3)

  • Detection rate of adenomas in each arm will be compared

    During the colonoscopy procedure

  • The rate of complete colonoscopy in each group

    During the colonoscopy procedure

  • Incidence of procedure- adverse events as assessed by complications reports

    From the colonoscopy procedure to one day after

Study Arms (2)

face to face + Tutorial

EXPERIMENTAL

one arm F+T "face to face + Tutorial" will have, in addition to all the items received by Group F, an email containing a link to a video tutorial explaining how to perform colonic preparation.

Procedure: Colonoscopy

face to face

ACTIVE COMPARATOR

The other arm F : "face to face" of patients will have the explanation of the colonic preparation and the administrative and legal documents of the centre's current practice by the gastro-enterologist.

Procedure: Colonoscopy

Interventions

ColonoscopyPROCEDURE

The explanation of the colonic preparation will be done at home by film tutorial, before the colonic procedure or as usual, by the physician during a specific consultation before the colonic procedure but the quality of preparation will be evaluated by the boston score as usual.

face to faceface to face + Tutorial

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Consecutive patients undergoing their first colonoscopy for gastrointestinal symptoms, family history of CRC or suspected CRC.
  • Ability to use the internet and a link to a video.
  • Life expectancy over three months.
  • Patient ≥ 18 years old, requiring a colonoscopy procedure.

You may not qualify if:

  • Patient with any psychiatric or psychological disorder that does not allow them a properd understanding and follow-up of the study.
  • Patient without internet access.
  • Patient requiring a colonoscopy procedure in emergency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Saint Joseph Saint Luc Hospital, Lyon, RHONE-ALPES

Lyon, 69007, France

RECRUITING

Clinique De L'infirmerie Protestante 3 Chem. du Penthod 69300 Caluire-et-Cuire

Lyon, France

RECRUITING

Clinique du Val d'ouest 39 chemin de la Vernique 69130 Ecully

Lyon, France

RECRUITING

Clinique Médico-Chirurgicale Charcot 51 rue Commandant Charcot 69110 Sainte-Foy-lès-lyon

Lyon, France

RECRUITING

Les portes du sud 2 avenue du 11 novembre 1918 69200 Vénissieux

Lyon, France

RECRUITING

MeSH Terms

Conditions

Digestive System Diseases

Interventions

Colonoscopy

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Marc O'BRIEN

    Hopital Saint Joseph Saint Luc

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2025

First Posted

January 21, 2026

Study Start

April 1, 2025

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

January 21, 2026

Record last verified: 2026-01

Locations