Colon Disease
Conditions
Keywords
colonoscopy, bowel preparation
Brief summary
Adequate quality of bowel preparation(BP) is essential for colonoscopy. Several guidelines recommend that split-dose of 4L PEG should be used as a standard regime for BP. However, the high-volume PEG caused lower compliance to the regime and increased cost. Oral lactulose is a treatment for constipation. It tastes sweet and has no obvious gastrointestinal side effects. Previous study shows 200ml lactulose oral solution plus 2L water has been proven superior BP compared to 2L PEG. However, there is a lack of research describing bowel cleansing and colonoscopy outcomes using lactulose oral solution compared with the standard split dose of 4L PEG. Here we compared the use of a lactulose oral solution (300ml+1.5 L) with a PEG formulation (2 L) for colonoscopy preparation using the following metrics: quality of cleansing, colonoscopy outcomes, patient/physician satisfaction, and patient tolerability.
Interventions
DRUGLactulose
In experiment cohort, patients do not use standard bowel preparation regimen, they totally drink 300ml lactulose.
In control cohort, patients use the standard split-dose bowel preparation regimen,
Sponsors
First People's Hospital of Hangzhou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* age 18-80 patients with intact colon and rectum
Exclusion criteria
* prior finding of severe colorectal stricture * without the requirement of reaching cecum * suspected colonic stricture or perforation * use of prokinetic agents or purgatives within 7 days * toxic colitis or megacolon * pregnant women * hemodynamically unstable * patients who cannot give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bowel preparation | 2 hours | Boston bowel preparation score (BBPS)：cleanliness of each part of the colon: 0=unprepared colon segment with mucosa not seen because of solid stool that cannot be cleared; 1=portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen because of staining, residual stool, and/or opaque liquid; 2=minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3=entire mucosa of colon segment seen well with no residual staining, small fragments of stool, or opaque liquid. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 2 hours | — |
| Willingness to repeat bowel preparation (BP) | 2 hours | We will ask patients in the form of questionnaire whether they are willing to repeat the same bowel preparation method if they need colonoscopy examination again. |
| Cecal intubation rate | 2 hours | — |
| Insertion time | 2 hours | — |
| Withdrawal time | 2 hours | — |
| Adenoma detection rate | 2 hours | — |
Contacts
Primary ContactHui Jia, MD
Outcome results
None listed