Bowel Preparation for Colonoscopy
Conditions
Keywords
Bowel preparation, Low-residue diet, colonoscopy
Brief summary
Previously, our team compared the effects of a low-residue full nutrition formula podwer (FNFP) combined with 3 liters of polyethylene glycol(PEG) solution and the self-prepared low-residue diet combined with 3 liters of PEG solution on the quality of bowel preparation for colonoscopy, and the results showed that the adequate bowel preparation rate was significantly improved in low-residue full nutrition formula podwer group. However, there are still a considerable number of patients in the process of taking 3L PEG appeared bloating, abdominal pain, nausea, vomiting and other adverse reactions, indicating some subjects can not tolerate the dosage of 3L PEG. In order to reduce adverse reactions and provide more options for people with low PEG tolerance, this study intends to compare the effects of low-residue FNFP combined with 2L PEG and self-provided low-residue diet combined with 3L PEG on the quality bowel preparation, colonoscopy lesions detection, adverse reactions, and tolerance, compliance and satisfaction of subjects.
Interventions
DIETARY_SUPPLEMENTLow-residue full nutrition formula podwer
The day before the colonoscopy, subjects were given a low-residue full nutrition formula podwer instead of a traditional self-prepared low-residue diet. Subjects were given 6 packs (60g/pack) pre-packaged FNFP and asked to use the FNFP according to individual needs. The 2 liters of polyethylene glycol solution is taken in split dosing, with 1 liter taken at 8pm the day before the colonoscopy and 1 liter taken 3-5 hours before the colonoscopy.
DIETARY_SUPPLEMENTSelf-prepared low-residue diet
Subjects in the self-prepared Low-residue diet group were instructed to follow and prepare an Low-residue diet in the day prior to colonoscopy. The 3 liters of polyethylene glycol solution is taken in split dosing, with 1 liter taken at 8pm the day before the colonoscopy and 2 liter taken 4-6 hours before the colonoscopy.
Sponsors
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* adult subjects between the ages of 18 and 75 who were scheduled for screening, monitoring, and diagnostic colonoscopy.
Exclusion criteria
* severe heart, brain, lung, kidney complications or a history of acute myocardial infarction within six months. * a history of abdominal or pelvic surgery, BMI \> 28 or BMI \< 18.5, inflammatory bowel disease, constipation (less than 3 bowel movements in the past week, with strenuous bowel movements, hard stool, small volume), or intestinal obstruction. * imaging and laboratory tests are highly suspicious of colorectal cancer or warning signs and symptoms of colorectal cancer: blood in the stool, black stool, unexplained anemia and significant weight loss, abdominal mass, and positive digital rectal examination.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adequate bowel preparation rate | Two months | Defined as score ≥ 2 for all colon segment (right-side colon, transverse colon, and left-side colon) according to the Boston Bowel Preparation Scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BBPS score (including total score, left colon, transverse colon, and right colon) | Two months | — |
| Aronchick Scale score | Two months | — |
| Bowel preparation completion rate | Two weeks | PEG intake is more than 90% of the requirement |
| Subject satisfaction rate | Two weeks | — |
| Excellent bowel preparation rate | Two months | — |
| Adenoma detection rate | Four weeks | — |
| Polyp detection rate | Two weeks | — |
| Compliance with FNFP | Two weeks | — |
| Colonoscopist satisfaction rate | Two weeks | — |
Countries
China
Outcome results
None listed