Status
Completed
Phase
Not applicable
Enrollment
1,607
Locations
1
Results
Not posted
Publications
2
Study 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
DRUG
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.
DRUG
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.
DRUG
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.
Timeline
First posted
Mar 22, 2022
Study start
May 25, 2022
Primary completion
Aug 30, 2023
Study completion
Apr 28, 2024
Results posted
Not reported
Registry updated
Jun 20, 2024
Outcomes
Bowel preparation adequate rate
Time frame · 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) .
Boston bowel preparation scale score
Time frame · 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.
Aronchick Scale
Time frame · 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
Time frame · 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
Time frame · 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
Time frame · 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.
Endoscopists satisfaction with the quality of bowel preparation
Time frame · 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.
Adenoma detection rate
Time frame · 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
Time frame · 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
Time frame · Immediately after questionnaire survey.
Proportion of subjects with adverse events occuring in intestinal preparation.
Drug compliance in linaclotide group
Time frame · Immediately after questionnaire survey.
Proportion of subjects Taking 3 linaclotide capsules according to the protocol in linaclotide group.
Eligibility
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.
Study locations
China. Showing up to 24 locations stored in the fast local snapshot.
Changhai Hospital, Naval Medical University
Shanghai, China
Publications
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