An interventional study of 3L PEG + Linaclotide and 3L PEG in Bowel Preparation for Colonoscopy, sponsored by Changhai Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-20.
Sponsored by Changhai Hospital · Not applicable, Interventional, and Diagnostic
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.
Changhai Hospital is the lead sponsor of 342 studies on the registry; 133 are open to participants now.
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Bowel preparation for colonoscopy was performed with 3L polyethylene glycol solution combined with 3-day linaclotide.
Drug: 3L PEG + Linaclotide
Bowel preparation for colonoscopy was performed with 3L polyethylene glycol solution without linaclotide.
Drug: 3L PEG
Bowel preparation for colonoscopy was performed with 2L polyethylene glycol solution combined with 3-day linaclotide.
Drug: 2L 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.
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.
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.
Bowel preparation adequate rate
The proportion of participants with all colon segment scores (right colon, transverse colon, left colon) were ≥ 2 according to Boston Bowel Preparation Scale (BBPS) .
Time frame: within 10 minute after viewing colonoscopy video.
Boston bowel preparation scale score
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.
Time frame: Within 10 minute after viewing colonoscopy video.
Aronchick Scale
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.
Time frame: Within 10 minute after viewing colonoscopy video.
Bowel preparation excellent rate
The proportion of participants with total score ≥ 8 according to Boston Bowel Preparation Scale.
Time frame: Within 10 minute after viewing colonoscopy video.
Bowel preparation completion rate assessed by questionnaire survey
Proportion of subjects with laxative intake greater than 90% of the required amount in protocol.
Time frame: Immediately after questionnaire survey.
Subjects satisfaction rate assessed by 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.
Time frame: Immediately after questionnaire survey.
Endoscopists satisfaction with the quality of bowel preparation
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.
Time frame: Immediately after colonoscopy.
Adenoma detection rate
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.
Time frame: 14 days after colonosopy.
Polyp detection rate
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.
Time frame: Immediately after colonoscopy.
Incidence of adverse events assessed by questionnaire survey
Proportion of subjects with adverse events occuring in intestinal preparation.
Time frame: Immediately after questionnaire survey.
Drug compliance in linaclotide group
Proportion of subjects Taking 3 linaclotide capsules according to the protocol in linaclotide group.
Time frame: Immediately after questionnaire survey.
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Changhai Hospital