Bowel Preparation for Colonoscopy
Conditions
Keywords
Linaclotide, Bowel preparation, colonoscopy
Brief summary
The clinical purpose of this study was to investigate whether the adjuvant application of linaclotide in bowel preparation for colonoscopy could improve the quality of bowel preparation or reduce the dosage of laxatives.
Interventions
DRUG3L PEG + Linaclotide
Before colonoscopy, particpant take linaclotide capsules for 3 days (1 tablet should be taken at least 30 minutes before the first meal every day). Particpant take 1500ml polyethylene glycol electrolyte solution within 1.5 hours from 20 p.m the night before the examination; and repeat the same dose of polyethylene glycol electrolyte solution 4-6 hours before colonoscopy.
DRUG3L PEG
Particpant take 1500ml polyethylene glycol electrolyte solution within 1.5 hours from 20 p.m the night before the examination; and repeat the same dose of polyethylene glycol electrolyte solution 4-6 hours before colonoscopy.
DRUG2L PEG + Linaclotide
Before colonoscopy, particpant take linaclotide capsules for 3 days (1 tablet should be taken at least 30 minutes before the first meal every day). Particpant take 1000ml polyethylene glycol electrolyte solution within 1 hours from 20 p.m the night before the examination; and repeat the same dose of polyethylene glycol electrolyte solution 4-6 hours before colonoscopy.
Sponsors
Shanxi Provincial People's Hospital
900 Hospital of Joint Logistics Support Force of PLA
Ruijin Hospital
The First Affiliated Hospital of Nanchang University
Qilu Hospital of Shandong University
The Affiliated Hospital of Qingdao University
The Third Affiliated Hospital of Wenzhou Medical University
Affiliated Yueqing Hospital of Wenzhou Medical University
The First Affiliated Hospital of Soochow University
The 7th Medical Center of the PLA General Hospital
The First Hospital of Jilin University
The Second Hospital of Hebei Medical University
The Affiliated Hospital of Inner Mongolia Medical University
The Second Affiliated Hospital of Dalian Medical University
Ningxia Medical University General Hospital
Affiliated Hospital of Qinghai University
Yunnan First People's Hospital
Second Xiangya Hospital of Central South University
Shanghai Zhongshan Hospital
Daping Hospital, Army Military Medical University
Zunyi Medical College
Huizhou Municipal Central Hospital
Affiliated Hospital of Southwest Medical University
The First Hospital of Shihezi University
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Tangdu Hospital of Air Force Military Medical University
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* 18-75 years old, male or female; * To undergo diagnostic, screening or monitoring colonoscopy; * Signed written informed consent;
Exclusion criteria
* Severe cardiopulmonary insufficiency, renal failure or a history of stroke or myocardial infarction within six months; * History of abdominal or pelvic surgery; * Pregnant and lactating women; * BMI \> 28, BMI \< 18.5, inflammatory bowel disease, constipation (defecation less than 3 times in the last week, and laborious defecation, fecal sclerosis, low volume) or intestinal obstruction and other high-risk factors of intestinal preparation; * Abnormal coagulation function or taking antiplatelet or anticoagulant drugs within 7 days; * Warning symptoms and signs of colorectal cancer: hematochezia, melena, unexplained anemia, low body weight, abdominal mass, positive digital rectal test; or imaging and laboratory tests highly suspect colorectal cancer; * Colon polyps have been identified; * Stow score 7 (watery, no solid mass), diarrhea was considered; * Participation in other interventional clinical trials within 60 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bowel preparation adequate rate | within 10 minute after viewing colonoscopy video. | The proportion of participants with all colon segment scores (right colon, transverse colon, left colon) were ≥ 2 according to Boston Bowel Preparation Scale (BBPS) . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Aronchick Scale | Within 10 minute after viewing colonoscopy video. | Overall bowel preparation was scored prior to irrigation or suction. The Aronchick Scale scoring rules: 1, excellent, a small amount of liquid, 95% mucous membrane is visible; 2, good, plenty of clear fluid, covering 5%-25% of mucous membrane, 90% mucous membrane is visible; 3, medium, semi-solid manure that cannot be sucked out or washed away, 90% mucous membrane is visible; 4, poor, semi-solid manure that cannot be sucked out or washed away, 90% mucous membrane is visible; 5, inadequate, repeated bowel preparation or reexamination is required. Total Aronchick score 1-5, the lower the score, the better the quality of bowel preparation. |
| Bowel preparation excellent rate | Within 10 minute after viewing colonoscopy video. | The proportion of participants with total score ≥ 8 according to Boston Bowel Preparation Scale. |
| Bowel preparation completion rate assessed by questionnaire survey | Immediately after questionnaire survey. | Proportion of subjects with laxative intake greater than 90% of the required amount in protocol. |
| Subjects satisfaction rate assessed by questionnaire survey | Immediately after questionnaire survey. | Proportion of subjects satisfacted with the whole intestinal preparation process. Subjects satisfaction was divided into four grades: 4, very satisfied; 3, moderately satisfied; 2, moderately dissatisfied; 1, very dissatisfied. Subjects in grades 3 and 4 were considered satisfied; subjects in grades 1 and 2 were considered dissatisfied. |
| Boston bowel preparation scale score | Within 10 minute after viewing colonoscopy video. | The BBPS scoring rules: 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 are 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 is seen well; 3, entire mucosa of colon segment seen well, with no residual staining, small fragments of stool, or opaque liquid. the higher the score, the better the quality of bowel preparation. 3 intestinal segments were scored separately: the right side of the colon, the transverse section of the colon, and the left side of the colon. Total BBPS score 0-9, the higher the score, the better the quality of bowel preparation. |
| Adenoma detection rate | 14 days after colonosopy. | The adenoma detection rate was calculated as the number of colonoscopies with at least one adenoma detected divided by the total number of colonoscopies in the group. Adenomatous polyps must be confirmed by pathological findings. |
| Polyp detection rate | Immediately after colonoscopy. | The polyp detection rate was calculated as the number of colonoscopies with at least one polyp detected divided by the total number of colonoscopies in the group. |
| Incidence of adverse events assessed by questionnaire survey | Immediately after questionnaire survey. | Proportion of subjects with adverse events occuring in intestinal preparation. |
| Drug compliance in linaclotide group | Immediately after questionnaire survey. | Proportion of subjects Taking 3 linaclotide capsules according to the protocol in linaclotide group. |
| Endoscopists satisfaction with the quality of bowel preparation | Immediately after colonoscopy. | Proportion of endoscopists satisfacted with the quality of bowel preparation during colonoscopy. Endoscopists satisfaction was divided into four grades: 4, very satisfied; 3, moderately satisfied; 2, moderately dissatisfied; 1, very dissatisfied. Subjects in grades 3 and 4 were considered satisfied; subjects in grades 1 and 2 were considered dissatisfied. |
Countries
China
Outcome results
None listed