Status:
COMPLETED
Application of Linaclotide Capsule in Bowel Preparation for Colonoscopy
Lead Sponsor:
Changhai Hospital
Collaborating Sponsors:
Shanxi Provincial People's Hospital
900 Hospital of Joint Logistics Support Force of PLA
Conditions:
Bowel Preparation for Colonoscopy
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 18-75 years old, male or female;
- To undergo diagnostic, screening or monitoring colonoscopy;
- Signed written informed consent;
Exclusion
- Severe cardiopulmonary insufficiency, renal failure or a history of stroke or myocardial infarction within six months;
- History of abdominal or pelvic surgery;
- Pregnant and lactating women;
- BMI \> 28, BMI \< 18.5, inflammatory bowel disease, constipation (defecation less than 3 times in the last week, and laborious defecation, fecal sclerosis, low volume) or intestinal obstruction and other high-risk factors of intestinal preparation;
- Abnormal coagulation function or taking antiplatelet or anticoagulant drugs within 7 days;
- Warning symptoms and signs of colorectal cancer: hematochezia, melena, unexplained anemia, low body weight, abdominal mass, positive digital rectal test; or imaging and laboratory tests highly suspect colorectal cancer;
- Colon polyps have been identified;
- Stow score 7 (watery, no solid mass), diarrhea was considered;
- Participation in other interventional clinical trials within 60 days.
Key Trial Info
Start Date :
May 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 28 2024
Estimated Enrollment :
1607 Patients enrolled
Trial Details
Trial ID
NCT05291325
Start Date
May 25 2022
End Date
April 28 2024
Last Update
June 20 2024
Active Locations (1)
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1
Changhai Hospital, Naval Medical University
Shanghai, China, 200433