Postoperative Surgical Recurrence Clinical Trial
Official title:
The MESOCOLIC Trial: Mesenteric Excision Surgery or Conservative Limited Resection in Crohn's Disease
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.
| Status | Recruiting |
| Enrollment | 116 |
| Est. completion date | January 2025 |
| Est. primary completion date | January 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 16 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - Patients with Crohn's disease limited to the distal ileum and/or right colon receiving their index ileocolonic resection - Patients with a documented history of Crohn's disease based on endoscopic, radiological, or histological criteria Exclusion Criteria: - Pregnancy or willingness to become pregnant in the following year - Previous ileocolic resection history - Patients having Crohn's disease lesion at a gastrointestinal site other than the terminal ileum cecum, or right colon - Patients having an internal fistula which required resection of another segment of bowel |
| Country | Name | City | State |
|---|---|---|---|
| China | General Hospital of Eastern Theater Command | Nanjing | Jiangsu |
| Lead Sponsor | Collaborator |
|---|---|
| Jinling Hospital, China | Sir Run Run Shaw Hospital, Sixth Affiliated Hospital, Sun Yat-sen University, The Cleveland Clinic, University Hospital of Limerick |
China,
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. — View Citation
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. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | postoperative operation-related complications | 30-day postoperative morbidity | 30 day | |
| Primary | Accumulated 5-year postoperative surgical recurrence | The requirement for repeat surgery for a Crohn's disease related indication. | 5 years after the first surgery | |
| Secondary | 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 | |
| Secondary | Accumulated 5-year clinical recurrence | 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 |