Crohn Disease Clinical Trial
— SPARESOfficial title:
MeSenteric SpAring Versus High Ligation Ileocolic Resection for the Prevention of REcurrent Crohn's DiseaSe (SPARES)
NCT number | NCT04578392 |
Other study ID # | 20-139 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 28, 2020 |
Est. completion date | December 31, 2027 |
Study description - Patients will be randomized according to post-operative recurrence risk to either a high ligation of ileocolic artery or mesenteric sparing ileocolic resection for terminal ileal Crohn's disease. The primary endpoint 6-month endoscopic recurrence. Endpoints - Primary endpoint; 6 months Secondary endpoints at 1 and 5 years post ileocecal resection Study population - Adult Crohn's disease patients with medically refractory terminal ileal Crohn's disease undergoing a primary ileocecal resection. Study sites - Multicenter international study Description of study intervention - Randomized control trial of two operative techniques Operative approach of a high ligation of ileocolic artery as compared to mesenteric sparing for a primary ileocolic resection Participate duration - 5 years
Status | Recruiting |
Enrollment | 181 |
Est. completion date | December 31, 2027 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Males and females 18-65 years of age. - Isolated ileocolic Crohn's disease of <30 cm in length - Concurrent therapies with corticosteroids, 5-ASA drugs, thiopurines, MTX, antibiotics, anti-TNF, vedolizumab, ustekinumab therapy are permitted. - Ability to comply with protocol - Competent and able to provide written informed consent - Medically refractory disease or inability to tolerate ongoing medical therapy Exclusion Criteria:Inability to give informed consent. - Patients less than 18 years of age - Patients undergoing repeat ileocolic resection - Patients with concurrent disease in other locations (e.g. proximal stricturing of the small bowel, fistulizing disease to the sigmoid colon) requiring an additional intervention in the operating room beyond an ileocolic resection. - Patients with >30 cm of terminal ileal disease - Patients who are undergoing an ileal resection only (NOT ileocecal) because the disease spares the distal most aspect of ileum and ileocecal valve - Patient whose anastomosis is diverted intra-operatively with a loop or end ileostomy - Clinically significant medical conditions within the six months before surgery: e.g. myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the patient. - Specific exclusions; Evidence of hepatitis B, C, or HIV - History of cancer including melanoma (with the exception of localized skin cancers) - Emergent indication for an operation - Pregnant or breast feeding. - History of clinically significant auto-immunity (other than Crohn's disease) or any previous example of fat-directed autoimmunity - Inability to follow up at respective sites for the primary endpoint |
Country | Name | City | State |
---|---|---|---|
Canada | Mt. Sinai | Toronto | Ontario |
Italy | Humanitas | Rozzano | Milano |
United Kingdom | St Mark's Hospital and Academic Institution | Harrow | Middlesex |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | Cedars-Sinai Hospital System | Los Angeles | California |
United States | Stanford University School of Medicine | Stanford | California |
United States | Cleveland Clinic Florida | Weston | Florida |
Lead Sponsor | Collaborator |
---|---|
The Cleveland Clinic |
United States, Canada, Italy, United Kingdom,
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* Note: There are 21 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Endoscopic recurrence based on Rutgeert scoring at the time of colonoscopy | Endoscopic recurrence is define as a Rutgeert score >2 at the time of colonoscopy The score is attributed directly, by selecting the appropriate degree - 5 degrees, from i0 (lowest) to i4 highest, with single-choice selection menu. Rutgeerts score is only be used for evaluation of post-surgical recurrences at ileocolic anastomosis level. | 6 months | |
Secondary | Clinical Recurrence - Crohn's Disease Activity Index (CDAI) | Clinical Recurrence is defined as an increase in CDAI >100 or CDAI >150
This tool used to quantify the symptoms of patients with Crohn's disease in order to define response or remission of disease. Remission of Crohn's disease is defined as CDAI below 150. Severe disease was defined as a value of greater than 450. Most major research studies on medications in Crohn's disease define response as a fall of the CDAI of greater than 70 points. (score ranges form 0 to over 600, the higher the score, the higher the disease state) |
6 months, 1 year | |
Secondary | Endoscopic Recurrence - Rutgeert score | Endoscopic recurrence is define as a score >2 at the time of colonoscopy The score is attributed directly, by selecting the appropriate degree - 5 degrees, from i0 (lowest) to i4 highest, with single-choice selection menu. Rutgeerts score is only be used for evaluation of post-surgical recurrences at ileocolic anastomosis level. | 1 year | |
Secondary | Surgical Recurrence | Surgical recurrence is define as need for repeat ileocolic resection due to recurrence at anastomotic site | 1 and 5 years |
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