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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000025994 |
Receipt No. | 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 | 2017/02/04 |
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 |
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Condition | ||
Condition | Ulcerative colitis | |
Classification by specialty |
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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?
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Key secondary outcomes | Patient characteristics, pre-operative pharmacotherapies, surgical outcomes such as operative time and hemorrhage, post-operative complications.
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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 |
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Interventions/Control_1 | CT(Computed tomography) scan before surgery.
Measurement of visceral obesity. |
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Eligibility | ||||
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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.
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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 |
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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 | ||||||
yu-horio@hyo-med.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
yu-horio@hyo-med.ac.jp |
Sponsor | |
Institute | Hyogo College of Medicine |
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Funding Source | |
Organization | Hyogo College of Medicine |
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Category of Funding Organization | Other |
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Secondary IDs | NO |
Study ID_1 | |
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IND to MHLW |
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Date of disclosure of the study information |
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URL releasing protocol | |
Publication of results | Unpublished |
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Baseline Characteristics | |
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Recruitment status | Preinitiation | ||||||
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Last modified on |
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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 | |
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Research case data | |
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