UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Necessity of rod in loop ileostomy
Title of the study (Brief title)	Rod in loop ileostomy
Region	Japan

Condition
Condition	ulcerative colitis
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The diverting loop ileostomy has a role for decreasing the re-operation due to septic complications with anastomotic leakage in restorative proctocolectomy for ulcerative colitis. However, there are appreciable complications with ostomy creation which includes necrosis, prolapsed, retraction, peristomal hernia, dermatitis, ulceration, fistula, and outlet obstruction. Traditionally, ileostomy rod is placed to prevent the stoma retraction in many institutions. However, preventive efficacy for retraction was not proved clearly and not seen proper evaluations but it is known to be associated with pressure ulcer and dermatitis by rod. Then, the primary objective of this study is to determine whether ostomy rod was useful to prevent stoma retraction and outlet obstruction when applied diverting loop ileostomy in UC surgery. The secondary objective is to clarify the incidence of pressure ulcer and dermatitis due to ostomy rod.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	stoma retraction
Key secondary outcomes	parastomal dermatitis

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	insertion of ostomy rod
Interventions/Control_2	Without ostomy rod
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	20 years-old <=
Age-upper limit	70 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with UC who underwent elective 2 staged procedures will be randomly divided into two groups with or without ostomy rod.
Key exclusion criteria	dirty/infected wound, emergency surgery, laparoscopic surgery, separated double barrel ileostomy and stoma creation without bowel resection
Target sample size	160

Research contact person
Name of lead principal investigator	Motoi Uchino
Organization	Hyogo College of Medicine
Division name	Dept of Surgery
Address	1-1,Mukogawacho, Nishinomiya city, Hyogo pref, Japan
TEL	0798-45-6371
Email	uchino2s@hyo-med.ac.jp

Public contact
Name of contact person	Motoi Uchino
Organization	Hyogo College of Medicine
Division name	Department of Surgery
Address	1-1,Mukogawacho, Nishinomiya city, Hyogo pref, Japan
TEL	0798-45-6371
Homepage URL
Email	motoi.uchino@nifty.ne.jp

Sponsor
Institute	Hyogo College of Medicine
Institute
Department

Funding Source
Organization	Hyogo college of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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 11 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 11 Month 01 Day
Anticipated trial start date	2011 Year 11 Month 01 Day
Last follow-up date	2014 Year 04 Month 01 Day
Date of closure to data entry	2014 Year 05 Month 01 Day
Date trial data considered complete	2014 Year 05 Month 01 Day
Date analysis concluded	2015 Year 05 Month 01 Day

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

Management information
Registered date	2011 Year 11 Month 02 Day
Last modified on	2016 Year 09 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007870