Status
Completed
Phase
Not applicable
Enrollment
720
Locations
8
Results
Not posted
Publications
0
Study 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.
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
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.
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.
Timeline
First posted
May 18, 2022
Study start
Aug 1, 2022
Primary completion
Jun 30, 2023
Study completion
Jul 15, 2023
Results posted
Not reported
Registry updated
May 23, 2024
Outcomes
Bowel preparation adequate rate
Time frame · 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
Time frame · 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.
Subject willingness to repeat the preparation
Time frame · 1 Day of colonoscopy
Survey
Tolerance to bowel preparation
Time frame · 1 Day of colonoscopy
It will be subjective and assessed as non, mild, moderate, severe.
Tolerance to colonoscopy
Time frame · 1 Day of colonoscopy
It will be subjective and assessed as non, mild, moderate, severe.
Average number of polyps per patient
Time frame · 1 Day of colonoscopy
Average number of polyps detected per patient by colonoscopy in each arm
Average number of adenomas per patient
Time frame · 1 Day of colonoscopy
Average number of adenomas detected per patient by colonoscopy in each arm
Withdrawal time
Time frame · 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
Time frame · 1 Day of colonoscopy
Cecal intubation was defined as reaching the ileocecal valve
Eligibility
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.
Study locations
China. Showing up to 24 locations stored in the fast local snapshot.
Ningxia Hui Autonomous Region People's Hospital
Yinchuan, Ningxia, China
Xi'an Central Hospital
Xi'an, Shaanxi, China
Xi'an Jiaotong University Second Affiliated Hospital
Xi'an, Shaanxi, China
Air Force 986 Hospital
Xi'an, Shaanxi, China
Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, China
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, China
Linfen Central Hospital
Linfen, Shanxi, China
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Publications
No PMID-linked publications were present in this registry snapshot.
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