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The purpose of this study is to compare the colon cleansing quality of linaclotide versus control in adult patients at high risk of inadequate bowel preparation: one group will receive polyethylene glycol solution (PEG) split dose (1 L + 2 L) plus linaclotide and the other group PEG (1 L + 2 L) plus placebo before colonoscopy.
The objective of this trial is to compare the colon cleanliness achieved with PEG split dose (1 L + 2 L) + linaclotide versus PEG split dose (1 L + 2 L) + placebo for patients scheduled for a colonoscopy at high risk of inadequate bowel preparation. The target patients are those with constipation, poor bowel preparation history, history of abdominal/pelvic surgery, comorbidity (diabetes, Parkinson's disease, stroke, or history of spinal cord injury), BMI > 25 kg/m2, age > 70, tricyclic antidepressants usage, or opioid usage, as defined by the latest version of Bowel Preparation Guidelines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3 L PEG + Linaclotide | Active Comparator | Bowel preparation for colonoscopy was performed with 3 L polyethylene glycol solution combined with 2-day linaclotide. |
|
| 3 L PEG + Placebo | Placebo Comparator | Bowel preparation for colonoscopy was performed with 3 L polyethylene glycol solution combined with 2-day placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3 L PEG + linaclotide | Drug | Participants take a linaclotide capsule on the day before colonoscopy at least 30 minutes before the first meal (if this is impossible, take the capsule as early as possible on that day). Participants take 1 L polyethylene glycol electrolyte solution within 1 hour from 8 p.m the night before the examination and take another linaclotide capsule and 2 L polyethylene glycol electrolyte solution 4 hours before the colonoscopy. |
| Measure | Description | Time Frame |
|---|---|---|
| Bowel preparation adequate rate | The rate of participants with all colon segment scores (proximal colon, transverse colon, distal colon) are ≥ 2 according to Boston Bowel Preparation Scale. | 48 hours |
| Number of adenomas per patient | If there is no significant difference in the first primary outcome between the two groups, compare the average number of adenomas per patient detected by colonoscopy. | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Subject willingness to repeat the preparation | Survey | 1 Day of colonoscopy |
| Tolerance to bowel preparation | It will be subjective and assessed as non, mild, moderate, severe. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhiguo Liu, M.D. | Study Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ningxia Hui Autonomous Region People's Hospital | Yinchuan | Ningxia | 750002 | China | ||
| Xi'an Central Hospital |
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| ID | Term |
|---|---|
| C523483 | linaclotide |
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A randomized grouping sequence by block randomization with a block size of 4 is generated using a web-based service. Linaclotide or placebo is allocated according to the sequence and labelled in numerial order (1 - 720) without labelling the allocation information. Therefore, patients, endoscopists, and other investigators at each center will be unaware of the drug allocation.
|
| 3 L PEG + placebo | Drug | Participants take a placebo capsule on the day before colonoscopy at least 30 minutes before the first meal (if this is impossible, take the capsule as early as possible on that day). Participants take 1 L polyethylene glycol electrolyte solution within 1 hour from 8 p.m the night before the examination and take another placebo capsule and 2 L polyethylene glycol electrolyte solution 4 hours before the colonoscopy. |
|
| 1 Day of colonoscopy |
| Tolerance to colonoscopy | It will be subjective and assessed as non, mild, moderate, severe. | 1 Day of colonoscopy |
| Average number of polyps per patient | Average number of polyps detected per patient by colonoscopy in each arm | 1 Day of colonoscopy |
| Average number of adenomas per patient | Average number of adenomas detected per patient by colonoscopy in each arm | 1 Day of colonoscopy |
| Withdrawal time | the time from cecal identification to the withdrawal of the colonoscopy across the anus minus the time of polypectomy. | 1Day of colonoscopy |
| Cecal intubation rate for colonoscopies | Cecal intubation was defined as reaching the ileocecal valve | 1 Day of colonoscopy |
| Xi'an |
| Shaanxi |
| 710004 |
| China |
| Xi'an Jiaotong University Second Affiliated Hospital | Xi'an | Shaanxi | 710004 | China |
| Air Force 986 Hospital | Xi'an | Shaanxi | 710036 | China |
| Xijing Hospital of Digestive Diseases | Xi'an | Shaanxi | 710036 | China |
| Shaanxi Provincial People's Hospital | Xi'an | Shaanxi | 710068 | China |
| Linfen Central Hospital | Linfen | Shanxi | 041000 | China |
| The Second Hospital of Shanxi Medical University | Taiyuan | Shanxi | China |