臨床研究等提出・公開システム

Japanese

Date of registration	May. 28, 2025
Last modified on	June. 05, 2026
Trial ID	jRCT1041250038

Scientific Title	A randomized prospective comparative study of split-dose Sulprep for bowel preparation before colonoscopy
Public Title	A randomized prospective comparative study of split-dose Sulprep for bowel preparation before colonoscopy

Contact for Scientific Queries	Name	Yamamura Takeshi
	Affiliation	Nagoya University, Graduate School of Medicine
	Address	Room 916, 9th floor, Medical Research Bldg. 1, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
	Telephone	+81-52-741-2172
	E-mail	yamamura.takeshi.x1@f.mail.nagoya-u.ac.jp
Contact for Public Queries	Name	Takada Naoki
	Affiliation	Nagoya University, Graduate School of Medicine
	Address	Room 916, 9th floor, Medical Research Bldg. 1, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
	Telephone	+81-52-741-2172
	E-mail	takada.naoki.w8@f.mail.nagoya-u.ac.jp

Recruitment status	Pending

Anticipated date of first enrollment		May. 28, 2025
Target sample size		196
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	parallel assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	Adult patients 18 years of age and older. Patients are scheduled for colonoscopy for surveillance after colorectal polypectomy, examination of fecal occult blood positivity, or colorectal screening for other diseases. Patients must be admitted to the hospital on or before the day before the examination and undergo pretreatment under inpatient care.
	Exclusion Criteria	Patients with a history of surgery of the gastrointestinal tract (excluding appendicectomy) Patients with suspected gastrointestinal obstruction or stenosis Patients with a history or suspicion of inflammatory bowel disease Suspected intestinal perforation, toxic megacolon, or gastric evacuation failure Severe renal dysfunction (CCr<30) Patients with a history of hypersensitivity to MOVIPREP or SULPREP ingredients Patients with a history of hypersensitivity to any of the ingredients of MOVIPREP or SULPREP.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		colorectal cancer
Intervention(s)		Patients undergoing colonoscopy will be randomly assigned to one of two groups: those undergoing pretreatment with the Sulprep split method and those undergoing pretreatment with the MobiPrep same-day method.
Health Condition(s) Keyword		colonoscopy
Intervention(s) Keyword		bowel preparation
Health Condition(s) Code		D015179
Intervention(s) Code		D003113
Primary Outcome(s)		Percentage of who complete bowel preparation within 3 hours
Secondary Outcome(s)		Time from start of pretreatment to completion of bowel preparation The amount of water taken on the day of the examination The number of patients who did not complete the pretreatment after taking the prescribed amount of laxatives and the details of the additional bowel preparations. Bowel Cleaness Bubble Score Subjects' acceptability evaluation (questionnaire) Symptoms of side effects during the bowel preparation

Secondary Sponsor

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Nagoya University Clinical Research Audit Committee
Address	65, Tsurumai-cho, Showa-ku, Nagoya City, Aichi
Telephone	+81-52-744-2479
E-Mail	iga-shinsa@t.mail.nagoya-u.ac.jp
Approval Status	Approval
Date of approval	Mar. 17, 2025

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
6	June. 05, 2026	(this page)	Changes
5	Sept. 16, 2025	Detail	Changes
4	July. 09, 2025	Detail	Changes
3	June. 18, 2025	Detail	Changes
2	June. 16, 2025	Detail	Changes
1	May. 28, 2025	Detail

List of change history