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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
