UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study of assessment for gastrointestinal motility function using radiopaque marker
Title of the study (Brief title)	The study of assessment for gastrointestinal motility function using radiopaque marker
Region	Japan

Condition
Condition	colorectal cancer
Classification by specialty	Surgery in general Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the recovery of postoperative gastrointestinal motility function by using radiopaque marker.
Basic objectives2	Others
Basic objectives -Others	It has been suggested that mechanical bowel preparation (MBP) is of no benefit in terms of anastomotic healing, infection rate, or improvement in postoperative course in patients undergoing elective colorectal surgery, indicating that MBP should be abandoned. However, the effect of MBP on postoperative gastrointestinal motility has been assessed subjectively. In this randomized trial, we assessed objectively the effect of MBP on postoperative gastrointestinal motility and mobility in elective colonic resection.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Transition and excretion rate of the radiopaque marker
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Preoprative mechanical bowel preparation
Interventions/Control_2	No preoperative mechanical preparation
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	This study included patients who underwent an elective open or laparoscope-assisted colonic resection (LAC) in our institute. All patients were invited to participate in this trial, which compared outcomes after surgery with or without preoperative MBP. General inclusion criteria were patients with (1) a primary tumor located from the cecum to the sigmoid colon and (2) an American Society of Anesthesiologists grade of I or II.
Key exclusion criteria	Exclusion criteria were a stoma, a complete intestinal obstruction that needed decompression, and a past history of another colonic resection.
Target sample size	100

Research contact person
Name of lead principal investigator	Eiji Uchida
Organization	Nippon Medical School
Division name	Department of surgery
Address	Sendagi 1-1-5 Bunkyo-ku, Tokyo
TEL	03-3822-2131
Email	uchida@nms.ac.jp

Public contact
Name of contact person	Takeshi Yamada
Organization	Nippon Medical School
Division name	Department of surgery
Address	Sendagi 1-1-5 Bunkyo-ku, Tokyo
TEL	03-3822-2131
Homepage URL
Email	y-tak@nms.ac.jp

Sponsor
Institute	Nippon Medical School Department of surgery
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2011 Year 04 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2011 Year 03 Month 20 Day
Anticipated trial start date	2011 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 03 Month 23 Day
Last modified on	2018 Year 04 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006295