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

NCT ID: NCT03681444

Last Updated: 2019-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2019-05-30

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.

Detailed Description

The study will be conducted in Makassed General Hospital (MGH) including all admitted patients receiving colonoscopy for the different indications. All patients will receive low volume 2L alpha peg split preps given 8 hours apart at a rate of 1 cup q 30 minutes with addition of 1 L of pure water post each liter with the addition 10mg of bisacodyl the night before.

In the trial, all adult inpatients (range, 18 to 80 years old) undergoing colonoscopy for CRC screening In MGH or with nonspecific gastrointestinal symptoms will be candidates for inclusion in the study. Exclusion criteria will be as follows: outpatient status; serious medical condi¬tions, such as severe cardiac, renal, liver, or metabolic disease; stroke or dementia; major psychiatric illness; known allergy to polyethylene glycol (PEG); a previous colon resection; incomplete colonoscopy examination (failure of cecal intubation); or functional constipation defined by Rome III diagnostic criteria.

Patient information was collected before procedure which included age, gender, weight, height, body mass index (BMI), indications for colonoscopy, and history of previous operation and colonoscopy, as well as bowel frequency. Patients will complete a questionnaire before colonoscopy regarding their preparation experience (the start and end time for PEG solution ingestion; the amount of PEG solution ingested; any associated adverse effects, includ¬ing abdominal pain, nausea, vomiting, headache, dizziness, and others; and willingness to repeat the same preparation in the future) with the help of an endoscopy nurse who will be blinded to the dietary randomization.

Participants were categorized into subgroups with regard to compliance; good compliance was defined as less than 25% of the PEG solution remaining, and poor compliance was defined as 25% or more of the PEG solution remaining. The subjects were randomly assigned to either eat Regular diet (RD), clear fluid diet (CLD) or low-residue diet (LRD) explained to each randomized case by in-hospital dietitian. In all three groups the offered diet was given at breakfast and lunch with fluids only given at dinner.

Conditions

Bowel Preparation Quality

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Regular diet

no dietary restriction

Group Type: EXPERIMENTAL

Regular diet

Intervention Type: OTHER

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

Colonoscopy

Intervention Type: DIAGNOSTIC_TEST

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

Clear fluid diet

no solid material

Group Type: PLACEBO_COMPARATOR

Clear fluid diet

Intervention Type: 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

Colonoscopy

Intervention Type: DIAGNOSTIC_TEST

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

Low residue diet

easy digestible food

Group Type: EXPERIMENTAL

Low residue diet

Intervention Type: 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.

Colonoscopy

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Regular diet

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

Intervention Type: 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

Intervention Type: 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.

Intervention Type: OTHER

Colonoscopy

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Makassed General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dr. Ghassan Hemadeh

Gastroenterologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ghassan Hemadeh, MD

Role: PRINCIPAL_INVESTIGATOR

Makassed General Hospital

Locations

Makassed General Hospital

Beirut, , Lebanon

Countries

Lebanon

Other Identifiers

10218

Identifier Type: -

Identifier Source: org_study_id