UMIN-CTR Clinical Trial

Basic information
Public title	Risk factors for postoperative small bowel obstruction after surgery for colorectal cancer
Acronym	Risk factors for postoperative small bowel obstruction after surgery for colorectal cancer
Scientific Title	Risk factors for postoperative small bowel obstruction after surgery for colorectal cancer
Scientific Title:Acronym	Risk factors for postoperative small bowel obstruction after surgery for colorectal cancer
Region	Japan

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

Objectives
Narrative objectives1	Investigating risk factors for small bowel obstruction after colorectal cancer surgery
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Development of small bowel obstruction
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	Patients with colorectal cancer who undergo operation in Second Department of Surgery, Wakayama Medical University or our related hospitals
Key exclusion criteria	(1) Patients with unresectable peritoneal dissemination nodules. (2) Patients with a history of intraperitoneal irradiation. (3) Patients with chronic inflammatory bowel disease (Crohn's disease / ulcerative colitis / Gastrointestinal Behcet's disease). (4) Other cases judged by the attending physician to be maladaptive.
Target sample size	800

Research contact person
Name of lead principal investigator	1st name Tsukasa Middle name Last name Hotta
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Zip code	641-8510
Address	811-1, Kimiidera, Wakayama 641-8510, Japan
TEL	073-441-0613
Email	hotta@wakayama-med.ac.jp

Public contact
Name of contact person	1st name Kenji Middle name Last name Matsuda
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Zip code	641-8510
Address	811-1, Kimiidera, Wakayama 641-8510, Japan
TEL	073-441-0613
Homepage URL
Email	kmatsuda@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University
Institute
Department

Funding Source
Organization	Wakayama Medical University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Research Ethics Committee of Wakayama Medical University
Address	811-1 Kimiidera, Wakayama, Wakayama Prefecture 641-8509, Japan
Tel	073-447-2300
Email	wa-rinri@wakayama-med.ac.jp

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	和歌山県立医科大学（和歌山）、済生会和歌山病院（和歌山）、南和歌山医療センター（和歌山）、済生会有田病院（和歌山）、和歌山労災病院（和歌山）、大阪南医療センター（大阪）、公立那賀病院（和歌山）、泉大津市立病院（大阪）、国保日高総合病院（和歌山）、橋本市民病院（和歌山）

Other administrative information
Date of disclosure of the study information	2020 Year 03 Month 19 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	985
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	Preparation for publication of results
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 05 Month 12 Day
Date of IRB	2009 Year 05 Month 12 Day
Anticipated trial start date	2009 Year 07 Month 06 Day
Last follow-up date	2017 Year 11 Month 29 Day
Date of closure to data entry	2017 Year 11 Month 29 Day
Date trial data considered complete	2017 Year 11 Month 29 Day
Date analysis concluded	2017 Year 11 Month 29 Day

Other
Other related information	prospective cohort study

Management information
Registered date	2020 Year 03 Month 18 Day
Last modified on	2020 Year 03 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045432