Bowel Preparation Quality Clinical Trial
Official title:
Diet Selection Pre-Colonoscopy: Any Difference Between Clear, Low-residue and Regular Diet on Bowel Prep Quality, Tolerance, Acceptance and Compliance
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02540031 -
The Impact of Additional Oral Preparation on the Quality of Bowel Preparation for Colonoscopy
|
Phase 3 |