Clear Liquid vs Liberalized Diet in Preparation for Colonoscopy

NCT02621658 | Unknown

• 1 other identifier: Bowel Prep Protocol
• Study Type: interventional
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

Colorectal cancer is the third most common cancer diagnosed in both men and women in the United States. The death rate from this disease, however, has been decreasing over the last 20 years. Early detection and removal of pre-malignant polyps is considered to be at the core of this change. At the same time, polyp detection is highly dependent on an adequate bowel preparation. Froehlich, et al., found that poor bowel preparation is associated with longer colonoscopy times, more difficult procedures and a higher rate of incomplete procedures(2). Although a Clear Liquid Diet is usually the prescribed diet in most bowel preparation regimes, several studies have shown similar results with less restrictive diets. Based on the hypothesis that a Full Liquid Diet(FLD) is not inferior to a Clear Liquid Diet(CLD), investigators plan to conduct a prospective, randomized trial, in order to compare these dietary interventions. The investigators and endoscopists will be blinded to patient's diet group. Researchers aim to investigate if diet liberalization to a Full Liquid Diet(FLD) is associated with similar bowel cleansing as compared with a Clear Liquid Diet(CLD). Investigators will compare the performance of these dietary interventions regarding adenoma detection rates(ADR), time to cecal intubation(TCI), and colonoscope withdrawal time. In addition, the investigators want to assess whether patient's Compliance and Satisfaction is similar or superior in the experimental group vs the control group.

Conditions

Colorectal Cancer

Keywords

Colorectal Cancer; Colonoscopy; Adenoma Detection Rate; Bowel Preparation; Time to Cecal Intubation

Outcome Measures

Primary Outcomes (4)

• Quality of Bowel Preparation

  This will be assessed using the Boston Bowel Preparation Scale

  At the time of Colonoscopy

• Time to Cecal Intubation

  During Colonoscopy

• Colonoscope Withdrawal time

  Time elapsed since the endoscopist starts withdrawing the colonoscope, after reaching the cecum, until the completion of the test.

  During Colonoscopy

• Adenoma Detection Rate

  Number of patients with at least one adenoma, divided by total number of patients aged 50 years or older screened with colonoscopy

  During Colonoscopy

Secondary Outcomes (2)

• Patient compliance

  Before Colonoscopy

• Patient satisfaction

  Before Colonoscopy

Study Arms (2)

Clear Liquid Diet

ACTIVE COMPARATOR

Clear Liquid Diet the day before colonoscopy.

Other: Clear Liquid Diet

Full Liquid Diet

EXPERIMENTAL

Full Liquid Diet the day before colonoscopy.

Other: Full Liquid Diet

Interventions

Clear Liquid Diet OTHER

Patients will be allowed to consume clear soft drinks like ginger ales, Sprite®, 7-Up®, Gatorade®, Kool Aid®. They can also have strained fruit juices like apple, white grape juice and lemonade, and water, tea and coffee without milk or non-dairy creamer. Patient in this arm will also be allowed to have low-sodium chicken or beef broth , in addition to non-red hard candies, Jell-O®, and popsicles.

Clear Liquid Diet

Full Liquid Diet OTHER

Patients will be allowed to consume a Full Liquid Diet, including nutritional supplements(Ensure®, Boost®, Glucerna®), strained cereals(like cream of wheat or strained oatmeal) and vegetables, purred fruit without seeds or pulp, milk, plain ice cream or yogurt, sherbet, coffee with cream, and tea.

Full Liquid Diet

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Asymptomatic patients 50 years old or older, undergoing screening colonoscopy and willing to participate in the study will be included, after obtaining informed/written consent.

You may not qualify if:

• Symptomatic patients, patients with indications for therapeutic colonoscopy, like for example, rectal bleeding or with a prior diagnosis requiring evaluation with colonoscopy(Prior diagnosis of colon polyps, Iron-deficiency Anemia, Inflammatory Bowel Disease, Colorectal Cancer, Chronic diarrhea, Abnormal Imaging) will be excluded from participation. Please note that patients with Iron-deficiency Anemia will not be excluded from the study, based solely on this diagnosis, if they have an indication, otherwise, for Screening Colonoscopy.

Sponsors & Collaborators

• San Antonio Military Medical Center: lead

Related Publications (9)

• Harewood GC, Sharma VK, de Garmo P. Impact of colonoscopy preparation quality on detection of suspected colonic neoplasia. Gastrointest Endosc. 2003 Jul;58(1):76-9. doi: 10.1067/mge.2003.294.

  PMID: 12838225 BACKGROUND

• Stolpman DR, Solem CA, Eastlick D, Adlis S, Shaw MJ. A randomized controlled trial comparing a low-residue diet versus clear liquids for colonoscopy preparation: impact on tolerance, procedure time, and adenoma detection rate. J Clin Gastroenterol. 2014 Nov-Dec;48(10):851-5. doi: 10.1097/MCG.0000000000000167.

  PMID: 25296243 BACKGROUND

• Jung YS, Seok HS, Park DI, Song CS, Kim SE, Lee SH, Eun CS, Han DS, Kim YS, Lee CK. A clear liquid diet is not mandatory for polyethylene glycol-based bowel preparation for afternoon colonoscopy in healthy outpatients. Gut Liver. 2013 Nov;7(6):681-7. doi: 10.5009/gnl.2013.7.6.681. Epub 2013 Aug 14.

  PMID: 24312709 BACKGROUND

• Froehlich F, Wietlisbach V, Gonvers JJ, Burnand B, Vader JP. Impact of colonic cleansing on quality and diagnostic yield of colonoscopy: the European Panel of Appropriateness of Gastrointestinal Endoscopy European multicenter study. Gastrointest Endosc. 2005 Mar;61(3):378-84. doi: 10.1016/s0016-5107(04)02776-2.

  PMID: 15758907 BACKGROUND

• Melicharkova A, Flemming J, Vanner S, Hookey L. A low-residue breakfast improves patient tolerance without impacting quality of low-volume colon cleansing prior to colonoscopy: a randomized trial. Am J Gastroenterol. 2013 Oct;108(10):1551-5. doi: 10.1038/ajg.2013.21.

  PMID: 24091500 BACKGROUND

• Full Liquid Diet vs Clear Liquid Diet for Colonoscopy Preparation: Preliminary Results. Gutkin E, et. al. ACG2011; Abstract P412

  BACKGROUND

• 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: 20883845 BACKGROUND

• Agresti A, Coull BA, Approximate is better than "exact" for interval estimation of binomial proportions, The American Statistician 52:119-126, 1998.

  BACKGROUND

• Jones B, Jarvis P, Lewis JA, Ebbutt AF. Trials to assess equivalence: the importance of rigorous methods. BMJ. 1996 Jul 6;313(7048):36-9. doi: 10.1136/bmj.313.7048.36.

  PMID: 8664772 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Luis X Velez-Colon, MD

  San Antonio Military Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luis X. Velez-Colon, MD

CONTACT

210-916-1759; luis.x.velezcolon.mil@mail.mil

Pedro A. Manibusan, DO

CONTACT

210-916-4367; pedro.a.manibusan.mil@mail.mil

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gastroenterology Fellow(PGY5)

Study Record Dates

• First Submitted: November 23, 2015
• First Posted: December 3, 2015
• Study Start: January 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 3, 2015

Record last verified: 2015-12