Postoperative Surgical Recurrence
Conditions
Brief summary
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.
Detailed description
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).
Interventions
PROCEDUREExtensive mesenteric resection
The mesentery is resected avoiding the root region.
PROCEDURELimited mesenteric excision
The mesentery is retained.
Sponsors
The Cleveland Clinic
University Hospital of Limerick
Sixth Affiliated Hospital, Sun Yat-sen University
Sir Run Run Shaw Hospital
Jinling Hospital, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accumulated 5-year postoperative surgical recurrence | 5 years after the first surgery | The requirement for repeat surgery for a Crohn's disease related indication. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Accumulated 5-year endoscopic recurrence | 5 years after the first surgery | 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) |
| Accumulated 5-year clinical recurrence | 5 years after the first surgery | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| postoperative operation-related complications | 30 day | 30-day postoperative morbidity |
Countries
China
Contacts
Primary ContactLi Yi, PhD
Outcome results
None listed