UMIN-CTR Clinical Trial

Basic information
Public title	Does the visceral obesity predict perioperative outcomes for ulcerative colitis?
Acronym	Visceral obesity in ulcerative colitis
Scientific Title	Does the visceral obesity predict perioperative outcomes for ulcerative colitis?
Scientific Title:Acronym	Visceral obesity in ulcerative colitis
Region	Japan

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

Objectives
Narrative objectives1	In general, obese patients are at increased surgical risk for perioperative complications. In recent years, a tendency towards obesity in patients with inflammatory bowel disease (IBD) has been reported. However, the relationship between obesity and the progress of IBD is not fully understood and there are limited data on the effect of obesity on perioperative outcomes in IBD patients. In obese patients undergoing surgery for ulcerative colitis (UC), there is a risk of increased operative time and hemorrhage. Another potential problem is difficulty in the pouch reaching the anus, owing to a thick intestinal membrane and a narrow pelvis in males. Whether the pouch will reach the anus cannot be predicted before surgery. It has been reported recently that obesity does not impact perioperative or postoperative outcomes in patients with IBD. However, BMI does not necessarily reflect visceral obesity. Furthermore, IBD patients are at increased risk of central obesity as a result of the use of corticosteroids. Overall, there is a need for alternative measures to BMI for evaluating obesity. There have been reports that visceral obesity is a more accurate predictor of perioperative complications than BMI in patients with colon or gastric cancer. Regarding IBD, it has been reported that visceral obesity is a predictive factor of perioperative complications in Crohn's disease, but this has not been reported for UC. Therefore, our aim is to investigate whether visceral obesity predicts perioperative outcomes in patients with UC.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Is visceral obesity a predictive factor in whether the pouch can reach the anus?
Key secondary outcomes	Patient characteristics, pre-operative pharmacotherapies, surgical outcomes such as operative time and hemorrhage, post-operative complications.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	CT(Computed tomography) scan before surgery. Measurement of visceral obesity.
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	15 years-old <=
Age-upper limit	70 years-old >
Gender	Male and Female
Key inclusion criteria	UC patients undergoing elective total proctocolectomy and ileal pouch anal anastomosis (IPAA) or total proctocolectomy and ileal pouch anal canal anastomosis (IACA) are included in the series.
Key exclusion criteria	UC patient undergoing panproctocolectomy with end ileostomy and emergency/urgent surgical cases (Including IPAA or IACA) are excluded from the series. Patient with a diagnosis or suspicion of Crohn's disease based on histological findings are also excluded.
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hiroki Ikeuchi
Organization	Hyogo College of Medicine
Division name	Department Inflammatory Bowel Disease
Zip code
Address	1-1, Mukogawa-cho, Nishinomiya Hyogo 663-8501, Japan
TEL	0798456372
Email	yu-horio@hyo-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yuki Horio
Organization	Hyogo College of Medicine
Division name	Department Inflammatory Bowel Disease
Zip code
Address	1-1, Mukogawa-cho, Nishinomiya Hyogo 663-8501, Japan
TEL	0798456372
Homepage URL
Email	yu-horio@hyo-med.ac.jp

Sponsor
Institute	Hyogo College of Medicine
Institute
Department

Funding Source
Organization	Hyogo College of Medicine
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
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	2017 Year 02 Month 10 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	Preinitiation
Date of protocol fixation	2017 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date	2017 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 02 Month 03 Day
Last modified on	2017 Year 02 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029873

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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