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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006657
Receipt No. R000007870
Scientific Title Necessity of rod in loop ileostomy
Date of disclosure of the study information 2011/11/03
Last modified on 2016/09/01

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Basic information
Public title Necessity of rod in loop ileostomy
Acronym Rod in loop ileostomy
Scientific Title Necessity of rod in loop ileostomy
Scientific Title:Acronym 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
1st name
Middle name
Last name Motoi Uchino
Organization Hyogo College of Medicine
Division name Dept of Surgery
Zip code
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
1st name
Middle name
Last name Motoi Uchino
Organization Hyogo College of Medicine
Division name Department of Surgery
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
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
2011 Year 11 Month 01 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000007870

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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