NCT02955901

Brief Summary

Colonoscopy is one of the most common methods for the diagnosis and treatment of lower gastrointestinal tract diseases and provides a unique opportunity to identify early neoplastic lesions. Adequate bowel preparation is important for optimal colonoscopy. New bowel-cleansing regimens, study of patient-related risk factors to fail a proper preparation and diet adaptations have been studied recently. A low residue diet is the standard in the day before the colonoscopy. Some endoscopists prescribe this dietary plan for a 3-day period prior to the exam, although no study compared the recommended 1-day versus 3-day diet regime, or the influence in bowel preparation results. The aim of this project is to determine if the use of a 3-day low residue diet improves bowel preparations results and the influence in patient tolerability and adherence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
412

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

October 25, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 4, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

July 16, 2019

Status Verified

July 1, 2019

Enrollment Period

1.9 years

First QC Date

October 25, 2016

Last Update Submit

July 13, 2019

Conditions

Colon DiseaseColonic Neoplasms

Keywords

Randomized controlled trialColonoscopyColon DiseaseLow residue dietColon preparation

Outcome Measures

Primary Outcomes (1)

  • Score of mucosal visualization

    Using Boston Bowel Preparation Scale during the exam

    1 day (during colonoscopy)

Secondary Outcomes (5)

  • Patient assessment of diet protocol

    1 day (the day of the exam)

  • Polyp detection rate, location and configuration

    1 day (during colonoscopy)

  • Adenoma Detection Rate

    Within 30 days from colonoscopy date

  • Cecum intubation rate

    1 day (during colonoscopy)

  • Withdrawal time

    1 day (during colonoscopy)

Other Outcomes (1)

  • Patients characteristics questionnaire

    1 day

Study Arms (2)

3-day low residue diet

ACTIVE COMPARATOR

Group A - 3 day low residue diet prior to the colonoscopy

Other: 3 day low residue diet prior to the colonoscopy

1-day low residue diet

PLACEBO COMPARATOR

Group B - 1 day low residue diet prior to the colonoscopy

Other: 1 day low residue diet prior to the colonoscopy

Interventions

3 day low residue diet prior to the colonoscopyOTHER

3 day low residue diet prior to the colonoscopy

3-day low residue diet
1 day low residue diet prior to the colonoscopyOTHER

3 day low residue diet prior to the colonoscopy

1-day low residue diet

Eligibility Criteria

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

You may qualify if:

  • Consecutive series of patients scheduled for total colonoscopy
  • Signed informed consent

You may not qualify if:

  • inpatients
  • sedation
  • urgent procedures
  • colonoscopies not intended to reach the caecum
  • patient with previous partial colectomy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Portuguese Oncology Institute - Coimbra

Coimbra, 3001 - 651, Portugal

Location

Related Publications (12)

  • Rex DK, Schoenfeld PS, Cohen J, Pike IM, Adler DG, Fennerty MB, Lieb JG 2nd, Park WG, Rizk MK, Sawhney MS, Shaheen NJ, Wani S, Weinberg DS. Quality indicators for colonoscopy. Gastrointest Endosc. 2015 Jan;81(1):31-53. doi: 10.1016/j.gie.2014.07.058. Epub 2014 Dec 2. No abstract available.

    PMID: 25480100BACKGROUND

  • 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

  • ASGE Standards of Practice Committee; Saltzman JR, Cash BD, Pasha SF, Early DS, Muthusamy VR, Khashab MA, Chathadi KV, Fanelli RD, Chandrasekhara V, Lightdale JR, Fonkalsrud L, Shergill AK, Hwang JH, Decker GA, Jue TL, Sharaf R, Fisher DA, Evans JA, Foley K, Shaukat A, Eloubeidi MA, Faulx AL, Wang A, Acosta RD. Bowel preparation before colonoscopy. Gastrointest Endosc. 2015 Apr;81(4):781-94. doi: 10.1016/j.gie.2014.09.048. Epub 2015 Jan 14. No abstract available.

    PMID: 25595062BACKGROUND

  • Bucci C, Rotondano G, Hassan C, Rea M, Bianco MA, Cipolletta L, Ciacci C, Marmo R. Optimal bowel cleansing for colonoscopy: split the dose! A series of meta-analyses of controlled studies. Gastrointest Endosc. 2014 Oct;80(4):566-576.e2. doi: 10.1016/j.gie.2014.05.320. Epub 2014 Jul 19.

    PMID: 25053529BACKGROUND

  • Cohen LB. Advances in bowel preparation for colonoscopy. Gastrointest Endosc Clin N Am. 2015 Apr;25(2):183-97. doi: 10.1016/j.giec.2014.11.003. Epub 2015 Jan 9.

    PMID: 25839681BACKGROUND

  • Hautefeuille G, Lapuelle J, Chaussade S, Ponchon T, Molard BR, Coulom P, Laugier R, Henri F, Cadiot G. Factors related to bowel cleansing failure before colonoscopy: Results of the PACOME study. United European Gastroenterol J. 2014 Feb;2(1):22-9. doi: 10.1177/2050640613518200.

    PMID: 24918005BACKGROUND

  • Song GM, Tian X, Ma L, Yi LJ, Shuai T, Zeng Z, Zeng XT. Regime for Bowel Preparation in Patients Scheduled to Colonoscopy: Low-Residue Diet or Clear Liquid Diet? Evidence From Systematic Review With Power Analysis. Medicine (Baltimore). 2016 Jan;95(1):e2432. doi: 10.1097/MD.0000000000002432.

    PMID: 26735547BACKGROUND

  • Nguyen DL, Jamal MM, Nguyen ET, Puli SR, Bechtold ML. Low-residue versus clear liquid diet before colonoscopy: a meta-analysis of randomized, controlled trials. Gastrointest Endosc. 2016 Mar;83(3):499-507.e1. doi: 10.1016/j.gie.2015.09.045. Epub 2015 Oct 13.

    PMID: 26460222BACKGROUND

  • Lijoi D, Ferrero S, Mistrangelo E, Casa ID, Crosa M, Remorgida V, Alessandri F. Bowel preparation before laparoscopic gynaecological surgery in benign conditions using a 1-week low fibre diet: a surgeon blind, randomized and controlled trial. Arch Gynecol Obstet. 2009 Nov;280(5):713-8. doi: 10.1007/s00404-009-0986-3. Epub 2009 Feb 20.

    PMID: 19229545BACKGROUND

  • Vanhauwaert E, Matthys C, Verdonck L, De Preter V. Low-residue and low-fiber diets in gastrointestinal disease management. Adv Nutr. 2015 Nov 13;6(6):820-7. doi: 10.3945/an.115.009688. Print 2015 Nov.

    PMID: 26567203BACKGROUND

  • Calderwood AH, Jacobson BC. Comprehensive validation of the Boston Bowel Preparation Scale. Gastrointest Endosc. 2010 Oct;72(4):686-92. doi: 10.1016/j.gie.2010.06.068.

    PMID: 20883845BACKGROUND

  • Parmar R, Martel M, Rostom A, Barkun AN. Validated Scales for Colon Cleansing: A Systematic Review. Am J Gastroenterol. 2016 Feb;111(2):197-204; quiz 205. doi: 10.1038/ajg.2015.417. Epub 2016 Jan 19.

    PMID: 26782820BACKGROUND

Related Links

MeSH Terms

Conditions

Colonic DiseasesColonic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasms

Study Officials

  • Filipe Taveira, MD

    Portuguese Oncology Institute, Coimbra

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 25, 2016

First Posted

November 4, 2016

Study Start

January 1, 2017

Primary Completion

December 1, 2018

Study Completion

May 1, 2019

Last Updated

July 16, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

PT(1)