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| Name | Class |
|---|---|
| University Hospital of Limerick | OTHER |
| The Cleveland Clinic | OTHER |
| Sixth Affiliated Hospital, Sun Yat-sen University | OTHER |
| Sir Run Run Shaw Hospital |
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The study evaluates whether there is a reduction in the rate of postoperative progression of the disease following extensive mesenteric excision (EME), when compared to that of limited mesenteric excision (LME), in patients undergoing ileocolic resection for Crohn's disease. Half of participants will receive EME, while the other half will receive LME.
EME and LME are the two surgical procedures which are commonly used in the treatment of Crohn's disease. However, the areas of the mesenteric tissue resected are different.
EME means that the mesentery is resected avoiding the root region, i.e. 1 cm from the root of ileocolic artery and vein.
LME represents that the mesentery is retained, i.e. "Close shave" or 3 cm from the border of bowel (using whatever approach - clips, or haemostatic vessel sealing device).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extensive mesenteric resection | Experimental | Mesenteric is resected avoiding the root region, i.e. 1 cm from the root of ileocolic artery and vein. |
|
| Limited mesenteric excision | Active Comparator | Mesentery is retained, i.e. "Close shave" or 3 cm from the border of bowel (using whatever approach - clips, or haemostatic vessel sealing device). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extensive mesenteric resection | Procedure | The mesentery is resected avoiding the root region. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Accumulated 5-year postoperative surgical recurrence | The requirement for repeat surgery for a Crohn's disease related indication. | 5 years after the first surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Accumulated 5-year endoscopic recurrence | Disease proximal to the anastomosis or in the perianastomotic are considered to be a endoscopic recurrence (Rutgeert's score i2, or higher, disease in other sites is not considered recurrence) | 5 years after the first surgery |
| Accumulated 5-year clinical recurrence |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative operation-related complications | 30-day postoperative morbidity | 30 day |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Yi, PhD | Contact | +86 13851843735 | liyi.jlh@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhu Weiming | Jinling Hospital, Nanjing, China. | Principal Investigator |
| John Calvin Coffey | University Hospital Limerick, Limerick, Ireland. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital of Eastern Theater Command | Recruiting | Nanjing | Jiangsu | 210000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29309546 | Background | Coffey CJ, Kiernan MG, Sahebally SM, Jarrar A, Burke JP, Kiely PA, Shen B, Waldron D, Peirce C, Moloney M, Skelly M, Tibbitts P, Hidayat H, Faul PN, Healy V, O'Leary PD, Walsh LG, Dockery P, O'Connell RP, Martin ST, Shanahan F, Fiocchi C, Dunne CP. Inclusion of the Mesentery in Ileocolic Resection for Crohn's Disease is Associated With Reduced Surgical Recurrence. J Crohns Colitis. 2018 Nov 9;12(10):1139-1150. doi: 10.1093/ecco-jcc/jjx187. | |
| 25307174 |
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| OTHER |
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| Limited mesenteric excision | Procedure | The mesentery is retained. |
|
The presence of endoscopic disease (i2, or higher) or radiological evidence plus the presence of symptoms attributable to Crohn's disease that are severe enough to require medical or surgical treatment. |
| 5 years after the first surgery |
| Luca Stocchi |
| The Cleveland Clinic |
| Principal Investigator |
| Background |
| Li Y, Zhu W, Gong J, Zhang W, Gu L, Guo Z, Cao L, Shen B, Li N, Li J. Visceral fat area is associated with a high risk for early postoperative recurrence in Crohn's disease. Colorectal Dis. 2015 Mar;17(3):225-34. doi: 10.1111/codi.12798. |
| 30043133 | Background | Li Y, Ge Y, Gong J, Zhu W, Cao L, Guo Z, Gu L, Li J. Mesenteric Lymphatic Vessel Density Is Associated with Disease Behavior and Postoperative Recurrence in Crohn's Disease. J Gastrointest Surg. 2018 Dec;22(12):2125-2132. doi: 10.1007/s11605-018-3884-9. Epub 2018 Jul 24. |
| 32085793 | Derived | Li Y, Mohan H, Lan N, Wu X, Zhou W, Gong J, Shen B, Stocchi L, Coffey JC, Zhu W. Mesenteric excision surgery or conservative limited resection in Crohn's disease: study protocol for an international, multicenter, randomized controlled trial. Trials. 2020 Feb 21;21(1):210. doi: 10.1186/s13063-020-4105-x. |