Diet Selection Pre-Colonoscopy: Comparison Between Clear, Low-residue and Regular Diet
Condition: Bowel Preparation Quality
Study type: Interventional

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.
    

Intervention name(s): Regular diet; Clear fluid diet; Low residue diet; Colonoscopy
Intervention type(s): Other; Other; Other; Diagnostic Test
Intervention description(s): Patients will be provided with any type of food preferred at any time in any quantity; 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; 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 will be performed under conscious sedation with intravenous midazolam and pethidine titrated as required
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Other