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| Name | Class |
|---|---|
| Crohn's & Colitis Foundation of America, Inc. | UNKNOWN |
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The purpose of this study is to compare the effect of two procedures - the Kono-S procedure and the side-to-side functional end to end anastomosis - on the microbiome (the bacteria that live in our gut) and on the intestinal immune system. The investigators are hypothesizing that there are differences in the microbiome environment and the immune environment between the two procedural groups.
These are two are different ways to re-connect the intestines after a portion of it is removed during surgery. Patients will be randomly assigned to either be re-connected with a procedure called the Kono-S anastomosis or with a side-to-side anastomosis during their surgery. This study will look at the microbiome and immune environment in the piece of intestine that is removed during surgery. Then, at the follow colonoscopies (3-6 month, 12-18 month, 60 month), biopsies (small pieces of tissue) will be taken near the connection between the small intestine and colon. This will be used to see how the microbiome and immune system in that area changed since the surgery. Genetic tests will be used to measure the microbiome and the levels of immune proteins in the intestines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kono-S anastomosis (KSa) | Experimental | Randomized enrollment of preoperative patients undergoing surgical resection for Crohn's ileitis or ileocolitis |
|
| side-to-side anastomosis (SSa) | Active Comparator | Randomized enrollment of preoperative patients undergoing surgical resection for Crohn's ileitis or ileocolitis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kono-S anastomosis (KSa) | Procedure | antimesenteric functional end-to-end handsewn anastomosis connecting small intestine and colon after surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in composition of the microbiome between treatment groups | Microbiome composition will be measured via an analysis of of 16S rRNA sequencing from tissue samples. | At the time of the surgery |
| Changes in the immune cell environment between treatment groups | Immune cell environment in the tissue will be measured by gene expression levels in the tissue sample via bulk RNA sequencing. | 3-6 month, 12-18 month and 60 month post-surgery endoscopy. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fabrizio Michelassi, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medical Center | New York | New York | 10065 | United States |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Side-to-side anastomosis (SSa) | Procedure | side-to-side anastomosis connecting small intestine and colon after surgery |
|
| D007410 | Intestinal Diseases |