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The comparison of the clinical utility between two kinds of bowel preparations (NaP Tablets and PEG salt solution)

The comparison of the clinical utility between two kinds of bowel preparations (NaP Tablets and PEG salt solution) - The comparison of the clinical utility between two kinds of bowel preparations (NaP Tablets and PEG salt solution)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000005385
Enrollment
500
Registered
2011-05-11
Start date
2011-05-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

The patients who need colonoscopy

Interventions

dosage:Sodium picosulfate hydrate is taken at 9 p.m. on the previous day of colonoscopy. 50 NaP tablets are taken 5 at a time every 15 minutes with about 200 ml of clear liquids, starting 4 to 6 hours

Sponsors

NTT Medical Center Tokyo, Gastroenterology Division
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients who need colonoscopy irrespective of sex, inpatients or outpatients. 2. Those who submit written informed consent.

Exclusion criteria

Exclusion criteria: A. Those who are true of contraindication to NaP or PEG solution: 1. patients with congestive heart failure or unstable angina, 2. patients with long QT syndrome or critical ventricular arrhythmia, 3. patients with ascites, 4. patients with or suspected of ileus, 5. patients with or suspected of bowel perforation, 6. patients with toxic megacolon, 7. patients with critical renal failure including hemodialysis patients and patients with acute phosphate nephropathy and 8. patients with a history of hypersensitivity of NaP or PEG solution. (As to PEG solution only 4, 5 and 6 are true of contraindication.) B. Those who are under 20 years old or 75 years old or more, or those who are 65 years old or more taking medicine which affect renal blood flow or function (such as diuretic, angiotensin-converting enzyme inhibitor, angiotensin-receptor antagonist, NSAIDs ). C. Those who are severely constipated (those who habitually take purgative or those who have less than 3 bowel movements a week). D. Those who have had their digestive tract operated (except a history of appendicitis operation) E. Those women who are pregnant, breast-feeding, or suspected of being pregnant. F. In addition, those who are judged to be inappropriate by doctors.

Design outcomes

Primary

MeasureTime frame
The quality of overall colon cleansing.

Secondary

MeasureTime frame
1. The quality of colon cleansing in each 6 lesion of colon (ileocecal lesion, ascending colon, transverse colon, descending colon, sigmoid colon and rectum). 2. The amount of time to reach the cecum 3. The success rate of reaching the cecum 4. The defecation condition and the patients tolerance (by questionnaire)

Countries

Japan

Contacts

Public ContactYosuke Tsuji

NTT Medical Center Tokyo gastroenterology division

ytsuji-tky@umin.ac.jp03-3448-6111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026