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

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

Interventions

OTHER

Regular diet

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

OTHER

Clear fluid diet

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

OTHER

Low residue diet

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.

DIAGNOSTIC_TEST

Colonoscopy

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

Sponsors & Collaborators

• Makassed General Hospital

  lead OTHER

Principal Investigators

• Ghassan Hemadeh, MD · Makassed General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-10-01

Primary Completion

2019-05-30

Completion

2019-05-30

Countries

• Lebanon

Study Locations