UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025994
Receipt number R000029873
Scientific Title Does the visceral obesity predict perioperative outcomes for ulcerative colitis?
Date of disclosure of the study information 2017/02/10
Last modified on 2024/02/09 09:11:31

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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 Hiroki
Middle name
Last name Ikeuchi

Organization

Hyogo College of Medicine

Division name

Department Inflammatory Bowel Disease

Zip code

663-8501

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 Yuki
Middle name
Last name Horio

Organization

Hyogo College of Medicine

Division name

Department Inflammatory Bowel Disease

Zip code

663-8501

Address

1-1, Mukogawa-cho, Nishinomiya Hyogo 663-8501, Japan

TEL

0798456372

Homepage URL


Email

yu-horio@hyo-med.ac.jp


Sponsor or person

Institute

Hyogo College of Medicine

Institute

Department

Personal name



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

Hyogo College of Medicine

Address

1-1, Mukogawa-cho, Nishinomiya Hyogo 663-8501, Japan

Tel

0798456066

Email

rinri@hyo-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



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

Open public recruiting

Date of protocol fixation

2017 Year 02 Month 01 Day

Date of IRB

2017 Year 03 Month 23 Day

Anticipated trial start date

2017 Year 04 Month 01 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2025 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2017 Year 02 Month 03 Day

Last modified on

2024 Year 02 Month 09 Day



Link to view the page

Value
https://center6.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