Diet Selection Pre-Colonoscopy: Comparison Between Clear, Low-residue and Regular Diet

NCT03681444 | Completed

• 1 other identifier: 10218
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

Colonoscopy has been used for ages as an evaluating tool of the colonic mucosa for screening and early detection of colonic cancer. Several studies have reported that poor bowel preparation reduces detection of polyps that may have the potential to be cancerous. Polyethylene glycol (PEG) has become the most commonly used agent for colon cleansing because it does not cause fluid exchange across the mucosal membrane and thereby limits fluid and electrolyte disturbances. Only a few studies have evaluated the effects of different diet types on bowel preparation under controlled circumstances. Various studies were made to find the best pre-colonoscopy diet with no single clear study comparing all 3 dietary regimen together was carried out. So, evidence for the efficacy of a RD (regular diet) in bowel preparation is lacking, which led us to question whether it is reasonable to recommend a RD for 24 hours prior to colonoscopy as part of a PEG-based bowel prepa¬ration in healthy inpatients. The investigators are proposing to carry out a randomized clinical trial at Makassed General Hospital and include patients from October 2018 till February 2019. The data of 90 stable adult patients will be obtained through patients' interviews. In the trial, all adult inpatients (range, 18 to 80 years old) undergoing colonoscopy for colorectal cancer (CRC) screening in Makassed General Hospital with nonspecific gastrointestinal symptoms will be candidates for inclusion in the study. Patient receiving endoscopy will be asked to answer multiple questions on the day of procedure. Patients will be randomly allocated to one of 3 groups: Regular Diet (RD), Clear Fluid (CF) and Low-Residue Diet (LRD). The primary outcome will consist of the quality of bowel preparation and efficacy of colon cleansing.

Conditions

Bowel Preparation Quality

Outcome Measures

Primary Outcomes (1)

• bowel preparation quality: Ottawa bowel preparation scale

  Bowel preparation quality will be assessed by Ottawa bowel preparation scale. The scale assesses three components of the large intestine: (1) the rectosigmoid colon, (2) the mid colon and (3) the right colon. A maximum score of 4 is used for each section of the large intestine. A score of 0 is given if the bowel preparation is excellent, a score of 1 is given if the bowel preparation is good, a score of 2 is given if the bowel preparation is fair, a score of 3 is given if the bowel preparation is poor, a score of 4 is given if the bowel preparation is inadequate. The total score is calculated by adding up all 3 scores. The scale has a range from 0 (perfect) to 14 (a completely unprepared colon).

  within 15 minutes after procedure

Secondary Outcomes (1)

• best convenient dietary regimen

  before procedure

Study Arms (3)

Regular diet

EXPERIMENTAL

no dietary restriction

Other: Regular diet; Diagnostic Test: Colonoscopy

Clear fluid diet

PLACEBO COMPARATOR

no solid material

Other: Clear fluid diet; Diagnostic Test: Colonoscopy

Low residue diet

EXPERIMENTAL

easy digestible food

Other: Low residue diet; Diagnostic Test: Colonoscopy

Interventions

Regular diet OTHER

Patients will be provided with any type of food preferred at any time in any quantity

Regular diet

Clear fluid diet OTHER

Patients will be provided with * Plain water * Fruit juices without pulp, such as grape juice, filtered apple juice, and cranberry juice * Soup broth (bouillon or consommé) * Clear sodas, such as ginger ale and Sprite * Gelatin (Jell-O) * Tea or coffee with no cream or milk added * Sports drinks that don't have color

Clear fluid diet

Low residue diet OTHER

The Low Residue Diet is the same as the soft diet with the added limitation of milk to one pint. It provides foods that are easily digestible. It is often used as a transition diet from liquids to the general diet. Indigestible fiber is reduced by using tender cooked vegetables and ripe, canned or cooked fruits from which the tough skins and seeds have been removed. Tender meat or meat made tender in the cooking process is used, thus reducing the amount of connective tissue. Adequacy: By following the recommended guidelines, the diet will be adequate according to the Recommended Daily Allowance. Note: For patients with dentures this diet can be modified by the substitution of ground meat for whole meat and excluding all raw vegetables. Personal tolerances determine food choices; avoid foods that cause GI (gastrointestinal) distress prior to the admission even though that food may be on the "foods included" list.

Low residue diet

Colonoscopy DIAGNOSTIC_TEST

Colonoscopy will be performed under conscious sedation with intravenous midazolam and pethidine titrated as required

Clear fluid diet; Low residue diet; Regular diet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• inpatients 18 to 75 years old
• undergoing colonoscopy for CRC screening
• with nonspecific gastrointestinal symptoms

You may not qualify if:

• outpatient status;
• serious medical conditions, such as severe cardiac, renal, liver, or metabolic disease;
• stroke or dementia;
• major psychiatric illness;
• known allergy to PEG;
• previous colon resection;
• incomplete colonoscopy examination (failure of cecal intubation);
• functional constipation defined by Rome III diagnostic criteria.

Sponsors & Collaborators

• Makassed General Hospital: lead

Study Sites (1)

Makassed General Hospital

Beirut, +961, Lebanon

Location

MeSH Terms

Interventions

Diet; Colonoscopy

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Ghassan Hemadeh, MD

  Makassed General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 19, 2018
• First Posted: September 24, 2018
• Study Start: October 1, 2018
• Primary Completion: May 30, 2019
• Study Completion: May 30, 2019
• Last Updated: September 27, 2019

Record last verified: 2019-09

Locations

LE (1)