Colonoscopy
Conditions
Keywords
colonoscopy, inadequate bowel preparation, Boston Bowel Preparation Scale, linaclotide
Brief summary
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.
Detailed description
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.
Interventions
DRUG3 L PEG + linaclotide
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.
DRUG3 L PEG + placebo
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.
Sponsors
Zhiguo Liu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* scheduled for colonoscopy * age ≥ 18 * meet any of the followings: functional constipation according to Rome IV criteria, poor bowel preparation history, BMI \> 25 kg/m2, age \> 70, history of abdominal/pelvic surgery, comorbidity (diabetes, Parkinson's disease, stroke, or history of spinal cord injury), antidepressant usage, opioid usage * willing to provide informed consent
Exclusion criteria
* unable to cooperate with questionnaires * uncontrolled hypertension (systolic .170 mm Hg and diastolic.100mmHg) * pregnancy or lactation * toxic colitis, or megacolon * allergy to preparation components * active inflammatory bowel disease * clinically significant electrolyte abnormalities * a history of severe renal, liver, or cardiac insufficiency * has already been enrolled in the study * gastrointestinal obstruction * obvious gastroparesis or gastric retention * bowel perforation * polyp syndrome * history of colectomy * any other condition that is inappropriate for enrollment as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bowel preparation adequate rate | 48 hours | The rate of participants with all colon segment scores (proximal colon, transverse colon, distal colon) are ≥ 2 according to Boston Bowel Preparation Scale. |
| Number of adenomas per patient | 48 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject willingness to repeat the preparation | 1 Day of colonoscopy | Survey |
| Tolerance to bowel preparation | 1 Day of colonoscopy | It will be subjective and assessed as non, mild, moderate, severe. |
| Tolerance to colonoscopy | 1 Day of colonoscopy | It will be subjective and assessed as non, mild, moderate, severe. |
| Average number of polyps per patient | 1 Day of colonoscopy | Average number of polyps detected per patient by colonoscopy in each arm |
| Average number of adenomas per patient | 1 Day of colonoscopy | Average number of adenomas detected per patient by colonoscopy in each arm |
| Withdrawal time | 1Day of colonoscopy | the time from cecal identification to the withdrawal of the colonoscopy across the anus minus the time of polypectomy. |
| Cecal intubation rate for colonoscopies | 1 Day of colonoscopy | Cecal intubation was defined as reaching the ileocecal valve |
Countries
China
Outcome results
None listed