Impact of Low Fiber Diet on Colonic Cleansing Quality (DIETPREP)

NCT03247452 | Completed

• 1 other identifier: Large bowel cleansing
• Study Type: interventional
• Target: 404
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single center randomized controlled trial to compare bowel cleansing for outpatient colonoscopy in two groups of participants: one group will receive instructions of one-day structured low fiber diet whilst the other group will receive three-day low fiber diet. Both groups will receive the same bowel cleansing solution (polyethylene glycol plus ascorbic acid). Bowel cleansing will be assessed according the Boston Bowel Preparation Scale.

Conditions

Cleansing Quality of the Colon

Keywords

Low fiber diet; Colonoscopy; Bowel Cleansing

Outcome Measures

Primary Outcomes (1)

• Boston Bowel Preparation Scale

  This scale goes from 0 (no preparation) to 3 points (excellent preparation) in the three segments of the colon (Proximal, transverse and distal). Maximum punctuation is 9 points

  7 months

Secondary Outcomes (2)

• Proportion of polyps detected in each arm

  7 months

• Degree of satisfaction with diet

  7 months

Study Arms (2)

One-day low fiber diet

ACTIVE COMPARATOR

Patients assigned to the active comparator will receive oral and written instructions about the same structured low fiber diet designed by an Endocrinologist but they will follow this diet only the day before colonoscopy. 2 liters of polyethylene glycol plus ascorbic acid will be administered

Other: One-day Low fiber diet; Drug: Polyethylene Glycol plus ascorbic acid

Three-day low fiber diet

EXPERIMENTAL

Patients assigned to the experimental group will receive oral and written instructions about a structured low fiber diet designed by an Endocrinologist. They must follow this diet three days before colonoscopy. 2 liters of polyethylene glycol plus ascorbic acid will be administered

Other: Three-day low fiber diet; Drug: Polyethylene Glycol plus ascorbic acid

Interventions

One-day Low fiber diet OTHER

One-day low fiber diet before colonoscopy

One-day low fiber diet

Three-day low fiber diet OTHER

Three days low fiber diet before colonoscopy

Three-day low fiber diet

Polyethylene Glycol plus ascorbic acid DRUG

2 liters of Polyethylene Glycol plus ascorbic acid will be administered to both groups

One-day low fiber diet; Three-day low fiber diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years

You may not qualify if:

• Patients with previous colon surgery
• Last colonoscopy with poor bowel preparation
• 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
• Phenylketonuria
• Deficiency of glucose-6-phosphate dehydrogenase
• Refusal to participate in the study
• Inability to follow the instructions

Sponsors & Collaborators

• Hospital Universitario de Canarias: lead

Study Sites (1)

Department of Gastroenterology

San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain

Location

Related Publications (5)

• 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: 23335011 RESULT

• 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: 26735547 RESULT

• Gimeno-Garcia AZ, Baute JL, Hernandez G, Morales D, Gonzalez-Perez CD, Nicolas-Perez D, Alarcon-Fernandez O, Jimenez A, Hernandez-Guerra M, Romero R, Alonso I, Gonzalez Y, Adrian Z, Carrillo M, Ramos L, Quintero E. Risk factors for inadequate bowel preparation: a validated predictive score. Endoscopy. 2017 Jun;49(6):536-543. doi: 10.1055/s-0043-101683. Epub 2017 Mar 10.

  PMID: 28282690 RESULT

• Wu KL, Rayner CK, Chuah SK, Chiu KW, Lu CC, Chiu YC. Impact of low-residue diet on bowel preparation for colonoscopy. Dis Colon Rectum. 2011 Jan;54(1):107-12. doi: 10.1007/DCR.0b013e3181fb1e52.

  PMID: 21160321 RESULT

• Gimeno-Garcia AZ, de la Barreda Heuser R, Reygosa C, Hernandez A, Mascareno I, Nicolas-Perez D, Jimenez A, Lara AJ, Alarcon-Fernandez O, Hernandez-Guerra M, Romero R, Alonso I, Gonzalez Y, Adrian Z, Hernandez G, Hernandez D, Delgado R, Quintero E. Impact of a 1-day versus 3-day low-residue diet on bowel cleansing quality before colonoscopy: a randomized controlled trial. Endoscopy. 2019 Jul;51(7):628-636. doi: 10.1055/a-0864-1942. Epub 2019 Apr 3.

  PMID: 30943553 DERIVED

MeSH Terms

Interventions

Polyethylene Glycols; Ascorbic Acid

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Carbohydrates

Study Officials

• Enrique Quintero, MD, PhD

  Hospital Universitario de Canarias

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Only the endoscopists in charged of rating cleansing quality during colonoscopy will be masked.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2017
• First Posted: August 11, 2017
• Study Start: December 18, 2017
• Primary Completion: March 31, 2018
• Study Completion: July 1, 2018
• Last Updated: August 15, 2018

Record last verified: 2018-08

Locations

ES (1)