Efficacy and Safety of single oral dose method of the Picoprep in colonoscopy

JRCT ID: jRCTs051220195

Registered date:17/03/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients scheduled for colonoscopy
• Date of first enrollment: 17/03/2023
• Target sample size: 145
• Study type: Interventional
• Intervention(s): Perform colonoscopy after taking Picoprep by the single oral dose

Outcome(s)

• Primary Outcome: Adequate bowel preparation rate (BBPS >= 6 points and >= 2 points in all segments)

Secondary Outcome

Efficucy endopoints
Boston bowel preparation score (BBPS) in the single oral dose method
Patient satisfaction score, Intubation time (time from anal insertion to cecum), Cecum intubation
Adenoma detection rate

Safety endopoint
Occurence of side efect

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. patients undergoing colonoscopy
2. age 18 years or older at the time of informed consent
3. pssible to take laxatives
4. possible to give written consent on his/her own

Exclude criteria

1. patients with severe renal dysfunction (eGFR< 30 mL/ min/ 1.73m2)
2. patients with severe heart failure (NYHA class III or IV)
3. patients with hyponaemia (<136 mEq/L) or hypokalaemia (<3.5 mEq/L)
4. Patients with previous surgical resection of the colon or rectum (except for appendectomy and small bowel resection)
5. patients with suspected intestinal obstruction or perforation
6. patients with suspected hemorrhagic lesions such as hemorrhage
7. Patients with suspected or pre-existing inflammatory bowel disease
8. pregnant women and patients who may be pregnant or lactating women
9. patients who have participated in another interventional study within 4 months
10. other patients deemed inappropriate by the investigators of this clinical study.

Related Information

• Primary Sponsor: Kodama Yuzo