Multicenter study to evaluate the efficacy of 1L Ascorbic acid PEG plus linaclotide for bowel preparation

JRCT ID: jRCTs051210162

Registered date:28/01/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: patients who require colonoscopy
• Date of first enrollment: 12/04/2022
• Target sample size: 1464
• Study type: Interventional
• Intervention(s): Patients receive linaclotide 0.5 mg or sennoside 24 mg prior to 1-L PEG-Asc.

Outcome(s)

• Primary Outcome: inadequate bowel preparation rate scored by Boston Bowel Preparation Scale (BBPS)
• Secondary Outcome: procedure-related parameters, safety and tolerability

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

1) patients who were scheduled for elective colonoscopy
2) patients who aged over 20 years old and under 85 years old
3) patients who were able to fill in the informed consent form for participation

Exclude criteria

1) severe heart failure (NYHA class III or IV)
2) severe hepatic failure (Child-Pugh C)
3) active inflammatory bowel disease
4) dementia
5) allergy to Moviprep, sennoside or linaclotide
6) advanced colorectal cancer
7) intestinal resection
8) past history of participance in this study

Related Information

• Primary Sponsor: Fujiwara Yasuhiro