Surgical Techniques for Crohn's Disease
(SPARES Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial allows participants to continue taking their current medications, including corticosteroids, 5-ASA drugs, thiopurines, MTX, antibiotics, anti-TNF, vedolizumab, and ustekinumab.
What data supports the effectiveness of the treatment High Ligation of Ileocolic Artery, Mesenteric Non-Sparing Ileocolic Resection, and Mesenteric Sparing Ileocolic Resection for Crohn's Disease?
The research indicates that laparoscopic-assisted ileocolic resection for Crohn's disease is a safe and feasible procedure, although complications like mesenteric pseudoaneurysm can occur. Additionally, high ligation of arteries, while used in other conditions like rectal cancer, may affect blood flow, but this does not necessarily increase the risk of complications like anastomotic leakage.12345
Is the surgical technique for Crohn's disease generally safe?
The surgical technique, including high ligation of the ileocolic artery, is generally considered safe, but there are potential risks such as pseudoaneurysms (abnormal bulging of blood vessels) and ischemia (reduced blood flow) if arteries are mistakenly ligated. These complications are rare and can often be managed effectively with prompt treatment.12678
How is the treatment High Ligation of Ileocolic Artery, Mesenteric Sparing different from other treatments for Crohn's disease?
This treatment is unique because it involves high ligation (tying off) of the ileocolic artery and sparing the mesentery (the tissue that attaches the intestines to the abdominal wall), which is different from traditional surgeries that often remove diseased mesentery. This approach may help reduce postoperative recurrence of Crohn's disease.29101112
What is the purpose of this trial?
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 resectionStudy population - Adult Crohn's disease patients with medically refractory terminal ileal Crohn's disease undergoing a primary ileocecal resection.Study sites - Multicenter international studyDescription 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 resectionParticipate duration - 5 years
Research Team
Amy Lightner, MD
Principal Investigator
The Cleveland Clinic
Eligibility Criteria
Adults aged 18-65 with Crohn's Disease affecting less than 30 cm of the terminal ileum and not responding to standard treatments can join. They must be able to follow the study protocol for 5 years and give consent. Excluded are those with a history of cancer, other significant medical conditions, or requiring additional surgeries beyond ileocolic resection.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Surgery
Participants undergo either a high ligation of ileocolic artery or mesenteric sparing ileocolic resection
Post-operative Monitoring
Participants are monitored for endoscopic recurrence using Rutgeerts score
Follow-up
Participants are monitored for clinical and surgical recurrence
Treatment Details
Interventions
- High Ligation of Ileocolic Artery
- Mesenteric Sparing
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Cleveland Clinic
Lead Sponsor