NCT04475146

Brief Summary

The research hypothesis is that video visualization improves the quality of bowel preparation and the patients' understanding of the modalities of bowel preparation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
282

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

First Submitted

Initial submission to the registry

July 2, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 17, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

3 years

First QC Date

July 2, 2020

Last Update Submit

September 16, 2024

Conditions

Keywords

video of bowel preparation

Outcome Measures

Primary Outcomes (1)

  • Comparison of colonoscopy percentage with a Boston score of 7 or higher and a score of 2 or higher in each segment, in group 1 "standard information and video visualization" versus in group 2 "standard information."

    Boston score

    Immediately after the colonoscopy

Secondary Outcomes (1)

  • A scale of understanding and satisfaction in relation to the quality of Information on intestinal preparation.

    2 hours after the colonoscopy

Study Arms (2)

Standard information and video visualization

Standard information and video visualization

Other: video vizualisation

Standard information, no video

Standard information, no video

Interventions

video vizualisation

Standard information and video visualization

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All major patients, without legal protection measures, understanding French and having access to the internet and an email address. Patient having a first outpatient colonoscopy with preparation by MOVIPREP. The study will be proposed by the investigator to patients followed for colonoscopy in the department of Hepato-gastroenterology. If patients accepted to participate in the protocol and the informed consent form is signed, patients will be included in the protocol.

You may qualify if:

  • Major patient
  • Patient with first indication of colonoscopy
  • Colonoscopy performed in outpatient with preparation by MOVIPREP
  • Patient affiliated with Social Security
  • Informed consent signed by the patient

You may not qualify if:

  • Hospitalized patients
  • With no Internet access, or no access to the email
  • Blind patients
  • Patient who don't speak French
  • Pregnant woman
  • Severe constipation (3 stools/week) or long-term laxatives
  • History of partial or total colectomy
  • Other preparation product

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre hospitalier intercommunal de Créteil

Créteil, 94100, France

Location

CHI Villeneuve St George

Villeneuve-Saint-Georges, France

Location

Study Design

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

Study Record Dates

First Submitted

July 2, 2020

First Posted

July 17, 2020

Study Start

September 1, 2020

Primary Completion

September 1, 2023

Study Completion

March 1, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations