NCT03933371

Brief Summary

The main purpose of the study is to determine risk factors of poor bowel cleansing in patients referred for colon capsule endoscopy (CCE) examination. Patients will be prepared with polyethylene glycol (PEG), and a booster by using oral low volume sodium phosphate (NaP) and sodium-amidotrizoate and meglumine-amidotrizoate (Gastrografin ®) The investigators also will try to design a predictive score of poor bowel cleansing and to validate the Bowel cleansing score designed by Leighton and modified by Spada

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
403

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

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

First Submitted

Initial submission to the registry

April 28, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 1, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

May 7, 2019

Status Verified

May 1, 2019

Enrollment Period

1.5 years

First QC Date

April 28, 2019

Last Update Submit

May 3, 2019

Conditions

Colon Adenoma

Keywords

colonoscopycapsuleCleansing

Outcome Measures

Primary Outcomes (1)

  • Colon cleansing

    Quality of bowel cleansing assessed by the Spada Bowel Preparation Scale. Cleansing is classified from 1 ( no preparation) to 4 (excellent preparation) in each of the 4 segments of the colon (proximal colon, transverse colon, distal colon and rectum)

    [Time frame: 20 months][Designated as safety issue: No]

Interventions

Colon Capsule EndoscopyDEVICE

The capsule endoscopy will be ingested by the participant. This device captures images along the large bowel. This images are stored in an external memory and afterwards they are downloaded in a computer

Eligibility Criteria

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

All patients referred for colon capsule endoscopy meeting inclusion and exclusion criteria will be included in the study. Spanish hospitals with the availability of colon capsule endoscopy will be invited to participate in the study

You may qualify if:

  • Age ≥ 18 years
  • Patients referred for colon capsule endoscopy

You may not qualify if:

  • Ileus, intestinal obstruction, megacolon.
  • Poorly controlled hypertension (HTAS\> 180 HTAD\> 100).
  • Terminal renal failure (pre-dialysis or dialysis).
  • Congestive heart failure (NYHA III-IV).
  • Acute liver failure.
  • Severe psychiatric illness.
  • Dementia with difficulty in the intake of the preparation.
  • Pregnancy or breastfeeding.
  • Refusal to participate in the study.
  • Inability to follow the instructions.
  • Alergies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Spada C, Hassan C, Munoz-Navas M, Neuhaus H, Deviere J, Fockens P, Coron E, Gay G, Toth E, Riccioni ME, Carretero C, Charton JP, Van Gossum A, Wientjes CA, Sacher-Huvelin S, Delvaux M, Nemeth A, Petruzziello L, de Frias CP, Mayershofer R, Amininejad L, Dekker E, Galmiche JP, Frederic M, Johansson GW, Cesaro P, Costamagna G. Second-generation colon capsule endoscopy compared with colonoscopy. Gastrointest Endosc. 2011 Sep;74(3):581-589.e1. doi: 10.1016/j.gie.2011.03.1125. Epub 2011 May 20.

    PMID: 21601200RESULT

  • Alarcon-Fernandez O, Ramos L, Adrian-de-Ganzo Z, Gimeno-Garcia AZ, Nicolas-Perez D, Jimenez A, Quintero E. Effects of colon capsule endoscopy on medical decision making in patients with incomplete colonoscopies. Clin Gastroenterol Hepatol. 2013 May;11(5):534-40.e1. doi: 10.1016/j.cgh.2012.10.016. Epub 2012 Oct 16.

    PMID: 23078891RESULT

  • Spada C, Hassan C, Galmiche JP, Neuhaus H, Dumonceau JM, Adler S, Epstein O, Gay G, Pennazio M, Rex DK, Benamouzig R, de Franchis R, Delvaux M, Deviere J, Eliakim R, Fraser C, Hagenmuller F, Herrerias JM, Keuchel M, Macrae F, Munoz-Navas M, Ponchon T, Quintero E, Riccioni ME, Rondonotti E, Marmo R, Sung JJ, Tajiri H, Toth E, Triantafyllou K, Van Gossum A, Costamagna G; European Society of Gastrointestinal Endoscopy. Colon capsule endoscopy: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2012 May;44(5):527-36. doi: 10.1055/s-0031-1291717. Epub 2012 Mar 2.

    PMID: 22389230RESULT

  • Spada C, Hassan C, Costamagna G. Colon capsule endoscopy. Gastrointest Endosc Clin N Am. 2015 Apr;25(2):387-401. doi: 10.1016/j.giec.2014.11.007. Epub 2015 Jan 28.

    PMID: 25839692RESULT

MeSH Terms

Interventions

Endoscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Antonio Z Gimeno Garcia, MD, PhD

    Hospital Universitario de Canarias

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Z Gimeno García, MD, PhD

CONTACT

34-922678000antozeben@gmail.com

Study Design

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

Study Record Dates

First Submitted

April 28, 2019

First Posted

May 1, 2019

Study Start

May 1, 2019

Primary Completion

November 1, 2020

Study Completion

December 1, 2020

Last Updated

May 7, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share