Bowel Preparation Before Colonoscopy
Conditions
Keywords
Colonoscopy, Lactulose, Polyethylene glycol, Bowel preparation
Brief summary
The purpose of this study is to evaluate the efficacy of polyethylene glycol（PEG） combined with lactulose for bowel preparation before colonoscopy in low-risk patients and high-risk patients.
Detailed description
The quality of bowel preparation is crucial for colonoscopy. Some high-risk factors for inadequate bowel preparation have been identified , including age \>70, previous colon surgery, constipation, diabetes, Parkinson's disease, history of stroke or spinal cord injury, prior history of inadequate bowel preparation, body mass index (BMI) \>25, use of tricyclic antidepressant or narcotics. Patients were considered as high risk if they have any of the above factors and considered as low risk if they did not have any of these risk factors.This is a multicenter, endoscopist-blinded study to compare the efficacy of PEG combined with lactulose and PEG alone in bowel preparation. In colonoscopy procedures, endoscopists who were blinded to the intervention evaluated the overall quality of colonoscopy cleaning according to the Boston Bowel Preparation Scale. Patients' tolerance, defecation, adverse events and adenoma detection rate (ADR) were also evaluated.
Interventions
DRUGPEG
Patients began to drink 1 L of PEG at 8:00 PM on the day before colonoscopy at a rate of 250 mL every 10- 15 minutes. On the day of the procedure, patients took the remaining 2 L of PEG 4-6 hours before colonoscopy.
DRUGPEG+lactulose
On the day before colonoscopy , Patients took 45 mL lactulose solution at 7:00 PM. And then Patients began to drink 1 L of PEG at 8:00 PM at a rate of 250 mL every 10- 15 minutes. On the day of the procedure, patients took 45 mL lactulose solution and the remaining 2 L of PEG 4-6 hours before colonoscopy.
Sponsors
Hubei Hospital of Traditional Chinese Medicine
Wuhan Central Hospital
Wuhan Third Hospital
The General Hospital of Central Theater Command
The Third People's Hospital of Hubei Province
Wuhan Puren Hospital
Wuhan Puai Hospital
Tian You Hospital Affiliated to Wuhan University of Science and Technology
Wuhan Red Cross Hospital
Renmin Hospital of Wuhan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Investigator)
Masking description
The allocation assignment of patients was performed by a designated technician at each center based on a computer-generated random sequence. The designated technician was not involved in the colonoscopy procedure.
Intervention model description
Patients scheduled for colonoscopy were stratified into low- and high-risk patients based on the inclusion criteria. Low- and high-risk patients were randomized to the PEG alone or lactulose combined with PEG group respectively.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
\- Adults undergoing colonoscopy.
Exclusion criteria
* 1.presence of any contraindications for colonoscopy (gastrointestinal obstruction or perforation,severe acute inflammatory bowel disease,toxic megacolon,severe heart failure,unable to swallow,severe heart failure,etc); * 2.Patients with galactosemia; * 3\. hypersensitivity to any of the ingredients; * 4.Pregnancy or lactation; * 5.Use of lactulose,prokinetic agents or purgatives within 7 days; * 6.Unwilling to sign informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Boston Bowel Preparation Scale | during colonoscopy | Cleanliness of the colon during colonoscopy will be evaluated by the Boston Bowel Preparation Scale which is a 4-point scoring system applied to each of 3 broad regions of the colon: the right side, the transverse section, and the left side. The total BBPS score ranged from 0 to 9. If total BostonBowel Preparation Score ≥6 with each segmental BBPS≥2, we regard it as adequate bowel preparation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of adverse events | 2 days | adverse events, such as vomiting, nausea, headache, abdominal distention,abdominal pain. |
| Cecal intubation rate | during colonoscopy | Colonoscopy reaches cecal region. |
| Cecal intubation time | during colonoscopy | Colonoscopy reaches cecal region. |
| Adenoma Detection Rate | 2 days | Diagnosis was confirmed by histologic examination |
| defecation frequency | 2 days | Frequency of bowel movement. |
| Willingness to repeat bowel preparation | 2 days | The number of patients have a willingness to undergo a repeated bowel preparation if needed. |
| Withdrawal time | during colonoscopy | The time from the cecum to the anus, but excluded time for biopsy performance or removal of polyps. |
Countries
China
Outcome results
None listed