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Application of linaclotide in bowel preparation before colonoscopy in patients with constipation

Application of linaclotide in bowel preparation before colonoscopy in patients with constipation

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081524
Enrollment
Unknown
Registered
2024-03-04
Start date
2024-01-02
Completion date
Unknown
Last updated
2024-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bowel preparation

Interventions

A:3L-PEG+linaclotide :A:Patients need to take 1 capsule of linaclotide (290ug/capsule) 30 minutes before the first meal every day 3 days before colonoscopy for 3 days, and do not take it on the day o
Take 2L of PEG solution 6 hours before colonoscopy for routine bowel preparation
B:4L-PEG:B:Patients do not take linacretide. Take 2L of PEG solution at 20 o'clock the night before the examination, and finish within 1-4 hours

Sponsors

The First Bethune Hospital of Jilin University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Adult outpatients (from 18- to 75-years-old) who were scheduled for a colonoscopy were enrolled in this study. constipation using Rome ? criteria (1) ages 18 to 75 years, irrespective of gender; (2) undergoing diagnostic, screening, or surveillance colonoscopy; (3) provision of written informed consent; (4) constipation as defined by the Rome IV criteria (fewer than three bowel movements per week with associated symptoms such as straining, hard or lumpy stools).

Exclusion criteria

Exclusion criteria: (1) history of stroke or acute myocardial infarction (within 6 months), severe heart failure (New York Heart Association class II–IV), chronic renal failure (stage 2–5) (2) history of abdominal or pelvic surgery (3) patients who were pregnant or breastfeeding during the study period (4) BMI>28,BMI<18.5,risk factors for bowel preparation, such as inflammatory bowel disease or intestinal obstruction (5) history aspirin, warfarin, or other anticoagulant drugs use, or history of blood coagulation disorders (6) alarm symptoms and signs of colorectal cancer: hematochezia, melena, anemia of unknown cause and weight loss, abdominal mass, positive digital rectal test; or imaging and laboratory tests with high suspicion of colorectal cancer; (7) colonic polyps have been identified (8) Bristol Stool Scale score 7 (watery, no solid mass), considered diarrhoea; (9) patients who were participating in other clinical trials in 60 days or patients who did not provide written informed consent.

Design outcomes

Primary

MeasureTime frame
Intestinal preparation pass rate;Reccal insertion rate;Colonoscopy operation time;

Secondary

MeasureTime frame
Excellent rate of bowel preparation;Colon polyp detection rate;Detection rate of colon adenoma;Evaluation of adverse reactions;Bowel preparation regimen is willing to repeat rate;

Countries

China

Contacts

Public ContactXu Hong

The First Hospital of Jilin University

x_hong@jlu.edu.cn+86 137 5666 1648

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026