NCT02401802

Brief Summary

This trial will compare the efficacy of 2 different sets of dietary recommendations to be followed before colon cleansing for colorectal cancer screening colonoscopy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
276

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 30, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 15, 2017

Status Verified

February 1, 2017

Enrollment Period

5 months

First QC Date

March 17, 2015

Last Update Submit

February 14, 2017

Conditions

Colonic Diseases

Keywords

ColonoscopyDietPolyethylene glycolsEfficacyPersonal satisfactionColorectal cancer screening

Outcome Measures

Primary Outcomes (1)

  • Inadequate bowel preparation.

    The efficacy of bowel preparation will be rated by blinded endoscopists using the Boston Bowel Preparation Scale (BBPS). Colonoscopies with a BBPS score of less than 5 points, or any segment rated less than 2 points will be considered with an inadequate bowel preparation

    1 hour after the colonoscopy

Secondary Outcomes (10)

  • Cecal intubation rate

    1 hour after the colonoscopy

  • Adenoma detection rate

    1 hour after the colonoscopy

  • Polyp detection rate

    1 hour after the colonoscopy

  • Abdominal pain

    6 hours after finishing bowel preparation

  • Nausea

    6 hours after finishing bowel preparation

  • +5 more secondary outcomes

Study Arms (2)

Low-residue diet

EXPERIMENTAL

The experimental group will receive 4 days of low-residue diet Laxative 4 liters polyethylene glycol 4000 in split fashion.

Dietary Supplement: Low-residue diet

Usual care

ACTIVE COMPARATOR

The control group will receive 3 days of low-residue diet followed by 24 hours of liquid diet. Laxative 4 liters polyethylene glycol 4000 in split fashion.

Dietary Supplement: Usual care

Interventions

Low-residue dietDIETARY_SUPPLEMENT

Subjects will be instructed by members of the research team to follow a standardized low residue diet for 4 days

Low-residue diet
Usual careDIETARY_SUPPLEMENT

Subjects will be instructed by members of the research team to follow a low-residue diet for 3 days followed by 24 hours of liquid diet

Usual care

Eligibility Criteria

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

You may qualify if:

  • Consecutive patients referred for a colonoscopy in a population-based colorectal screening program.

You may not qualify if:

  • Unwillingness to participate.
  • Inability to follow instructions
  • Active inflammatory bowel disease
  • Incomplete colonoscopies for technical reasons or contraindication as evaluated by the endoscopist

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital del Mar

Barcelona, Barcelona, 08003, Spain

Location

Related Publications (2)

  • Soweid AM, Kobeissy AA, Jamali FR, El-Tarchichi M, Skoury A, Abdul-Baki H, El-Zahabi L, El-Sayyed A, Barada KA, Sharara AI, Mourad F, Arabi A. A randomized single-blind trial of standard diet versus fiber-free diet with polyethylene glycol electrolyte solution for colonoscopy preparation. Endoscopy. 2010 Aug;42(8):633-8. doi: 10.1055/s-0029-1244236. Epub 2010 Jul 9.

    PMID: 20623443BACKGROUND

  • Alvarez-Gonzalez MA, Pantaleon MA, Flores-Le Roux JA, Zaffalon D, Amoros J, Bessa X, Seoane A, Pedro-Botet J; PROCOLON group. Randomized Clinical Trial: A Normocaloric Low-Fiber Diet the Day Before Colonoscopy Is the Most Effective Approach to Bowel Preparation in Colorectal Cancer Screening Colonoscopy. Dis Colon Rectum. 2019 Apr;62(4):491-497. doi: 10.1097/DCR.0000000000001305.

    PMID: 30844973DERIVED

MeSH Terms

Conditions

Colonic DiseasesPersonal Satisfaction

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesBehavior

Study Officials

  • Marco Antonio Alvarez González, MD, PhD

    Parc de Salut Mar

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 17, 2015

First Posted

March 30, 2015

Study Start

January 1, 2015

Primary Completion

June 1, 2015

Study Completion

December 1, 2015

Last Updated

February 15, 2017

Record last verified: 2017-02

Locations

ES(1)