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| Name | Class |
|---|---|
| Shanxi Provincial People's Hospital | OTHER_GOV |
| 900th Hospital of PLA Joint Logistic Support Force | OTHER |
| Ruijin Hospital | OTHER |
| The First Affiliated Hospital of Nanchang University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3L PEG + Linaclotide | Experimental | Bowel preparation for colonoscopy was performed with 3L polyethylene glycol solution combined with 3-day linaclotide. |
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| 3L PEG alone | Active Comparator | Bowel preparation for colonoscopy was performed with 3L polyethylene glycol solution without linaclotide. |
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| 2L PEG + Linaclotide | Experimental | Bowel preparation for colonoscopy was performed with 2L polyethylene glycol solution combined with 3-day linaclotide. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3L PEG + Linaclotide | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) . | within 10 minute after viewing colonoscopy video. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhaoshen Li | Changhai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai Hospital, Naval Medical University | Shanghai | 200433 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34034273 | Background | Zhang M, Zou W, Xu C, Jia R, Liu K, Xu Q, Xu H. Polyethylene glycol combined with linaclotide is an effective and well-tolerated bowel preparation regimen for colonoscopy: an endoscopist-blinded, randomized, controlled trial. Eur J Gastroenterol Hepatol. 2021 Dec 1;33(1S Suppl 1):e625-e633. doi: 10.1097/MEG.0000000000002184. | |
| 40423516 |
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| ID | Term |
|---|---|
| C523483 | linaclotide |
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| OTHER |
| Qilu Hospital of Shandong University | OTHER |
| The Affiliated Hospital of Qingdao University | OTHER |
| The Third Affiliated Hospital of Wenzhou Medical University | OTHER |
| Affiliated Yueqing Hospital of Wenzhou Medical University | OTHER |
| The First Affiliated Hospital of Soochow University | OTHER |
| Seventh Medical Center of PLA Army General Hospital | OTHER |
| The First Hospital of Jilin University | OTHER |
| The Second Hospital of Hebei Medical University | OTHER |
| The Affiliated Hospital of Inner Mongolia Medical University | OTHER |
| The Second Affiliated Hospital of Dalian Medical University | OTHER |
| Ningxia Medical University General Hospital | UNKNOWN |
| Affiliated Hospital of Qinghai University | OTHER |
| The First People's Hospital of Yunnan | OTHER |
| Second Xiangya Hospital of Central South University | OTHER |
| Shanghai Zhongshan Hospital | OTHER |
| Daping Hospital of Army Medical University | OTHER |
| Zunyi Medical College | OTHER |
| Huizhou Municipal Central Hospital | OTHER |
| Affiliated Hospital of Southwest Medical University | OTHER |
| The First Hospital of Shihezi University | UNKNOWN |
| Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
| The Second Affiliated Hospital of Air Force Military Medical University | OTHER |
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|
| 3L PEG | 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. |
|
| 2L PEG + Linaclotide | 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. |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | Immediately after colonoscopy. |
| Incidence of adverse events assessed by questionnaire survey | Proportion of subjects with adverse events occuring in intestinal preparation. | Immediately after questionnaire survey. |
| Drug compliance in linaclotide group | Proportion of subjects Taking 3 linaclotide capsules according to the protocol in linaclotide group. | Immediately after questionnaire survey. |
| Pan P, Chen H, Wang T, Liu K, Tuo B, Wang R, Fu H, Jiang C, Chen L, Zhao Q, Wang W, Chen W, Guo Q, Chen W, Li Y, Tian Z, Feng Z, Yang S, Fan Y, Luan F, Chen Y, Li Z, Bai Y. Effect of 3-Day Linaclotide Administration to Reduce the Polyethylene Glycol Volume for Colonoscopy Bowel Preparation: A Multicenter, Noninferiority, Randomized Controlled Trial. Am J Gastroenterol. 2026 Feb 1;121(2):453-460. doi: 10.14309/ajg.0000000000003557. Epub 2025 May 27. |