Surgical Techniques for Crohn's Disease
(SPARES Trial)
Recruiting in Palo Alto (17 mi)
+6 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: The Cleveland Clinic
Disqualifiers: Repeat resection, Other disease locations, Cancer, others
No Placebo Group
Trial Summary
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 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
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.
12345Is 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.
12678How 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.
29101112Eligibility 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
I am between 18 and 65 years old.
My condition hasn't improved with current treatment or I can't tolerate it.
My Crohn's disease affects less than 30 cm of my ileocolic region.
+3 more
Exclusion Criteria
I have had cancer before, but not melanoma or any non-localized skin cancers.
I need surgery urgently.
I haven't had major heart issues or other serious health problems in the last 6 months.
+11 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Surgery
Participants undergo either a high ligation of ileocolic artery or mesenteric sparing ileocolic resection
1 week
1 visit (in-person)
Post-operative Monitoring
Participants are monitored for endoscopic recurrence using Rutgeerts score
6 months
1 visit (in-person)
Follow-up
Participants are monitored for clinical and surgical recurrence
5 years
Annual visits (in-person)
Participant Groups
The SPARES trial is testing two surgical methods in Crohn's patients: high ligation versus mesenteric sparing of the ileocolic artery during resection. It aims to see which technique better prevents disease recurrence after surgery, monitored over six months to five years.
2Treatment groups
Active Control
Group I: mesenteric sparing for a primary ileocolic resectionActive Control2 Interventions
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
Group II: high ligation of ileocolic arteryActive Control2 Interventions
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Cleveland Clinic FloridaWeston, FL
Mt. SinaiToronto, Canada
Cleveland ClinicCleveland, OH
Cedars-Sinai Hospital SystemLos Angeles, CA
More Trial Locations
Loading ...
Who Is Running the Clinical Trial?
The Cleveland ClinicLead Sponsor
References
High Ligation of the Inferior Mesenteric Artery Induces Hypoperfusion of the Sigmoid Colon Stump During Anterior Resection. [2021]Background: Anastomotic leakage (AL) after colorectal surgery is associated with insufficient vascular perfusion of the anastomotic ends. This study aimed to evaluate the effect of high vs. low ligation of the ileocolic artery and inferior mesenteric artery, respectively, on the vascular perfusion of the bowel stumps during ileocecal resection (ICR) and anterior rectal resection (AR). Methods: We retrospectively evaluated patients who underwent ICR or AR between 2016 and 2020. Real-time indocyanine green fluorescence angiography was performed to measure the fluorescence time (FT) as a marker of the blood flow in the proximal and distal stumps before anastomosis. Results: Thirty-four patients with lower right-sided colon cancer underwent laparoscopic ICR. Forty-one patients with rectosigmoid colon or rectal cancer underwent robotic high AR (HAR) (n = 8), robotic low AR (LAR) (n = 6), laparoscopic HAR (n = 8), or laparoscopic LAR (n = 19). The FT was similar in the ileal and ascending colon stumps (p = 1.000) and did not differ significantly between high vs. low ligation of the ileocolic artery (p = 0.934). The FT was similar in the sigmoid colon and rectal stumps (p = 0.642), but high inferior mesenteric artery ligation significantly prolonged FT in the sigmoid colon during AR compared with low ligation (p = 0.004), indicating that the high ligation approach caused significant hypoperfusion compared with low ligation. The AL rate was similar after low vs. high ligation. Conclusions: Low vascular perfusion of the bowel stumps may not be an absolute risk factor for AL. High inferior mesenteric artery ligation could induce sigmoid colon stump hypoperfusion during anterior rectal resection.
Endovascular treatment of ileocolic pseudoaneurysm after a laparoscopic-assisted bowel resection for Crohn disease. [2016]Since the introduction of laparoscopic-assisted ileocolic resection for Crohn disease more than 15 years ago, it has become established as a challenging but feasible and safe procedure. A crucial step in the operation is the division of the thick and chronically inflamed mesentery, which in many cases is performed extracorporeally. We report a case of a 32-year-old man with a 14-year history of Crohn ileitis who underwent elective laparoscopic-assisted ileocolic resection. His procedure and the postoperative course were uneventful. A computed tomography scan 2 weeks later revealed a 3-cm-diameter asymptomatic mesenteric pseudoaneurysm, which was successfully treated by transcatheter coil embolization. Pseudoaneurysm of mesenteric arteries has not been documented before in relation to bowel resection by conventional or minimally invasive approaches. It is likely that the thick vascular mesentery of this patient with Crohn disease was a contributing factor to this complication.
[Accurate low ligation of inferior mesenteric artery and root lymph node dissection according to different vascular typing in laparoscopic radical resection of rectal cancer]. [2018]To explore the feasibility and clinical significance of precision low inferior mesenteric artery (IMA) ligation with the left colonic artery (LCA) preservation and root lymph node dissection in laparoscopic radical resection for rectal cancer, according to the inferior mesenteric artery (IMA) types.
Randomized clinical trial of high versus low inferior mesenteric artery ligation during anterior resection for rectal cancer. [2022]The optimal level for inferior mesenteric artery ligation during anterior resection for rectal cancer is controversial. The aim of this randomized trial was to clarify whether the inferior mesenteric artery should be tied at the origin (high tie) or distal to the left colic artery (low tie).
A clinical study of inferior mesenteric artery typing in laparoscopic radical resections with left colonic artery preservation of rectal cancer. [2022]An investigation of the effects of different types of the inferior mesenteric artery (IMA) on laparoscopic left colic artery (LCA) radical resection of rectal cancer was conducted.
Ileal long-segment ischemia after the unintended ligation of variant ileal branch during laparoscopic right hemicolectomy. [2022]The variant terminal trunk of the superior mesenteric artery (SMA) could be confused with the ileocolic artery (ICA) as it runs on the right side of the superior mesenteric vein. If the variant ileal branch of SMA is mistaken for the ICA, unintentional ligation could cause long-segment ischemia in the ileum. We encountered a rare case of ileal ischemia caused by unintentional ligation of the variant ileal branch of the SMA during laparoscopic right hemicolectomy, which was confirmed by indocyanine green (ICG) angiography and hyperspectral imaging (HSI). Intraoperative real-time perfusion monitoring using ICG angiography and tissue oxygen saturation monitoring using HSI could help detect segments of hypoperfusion and prevent hypoperfusion-related anastomotic complications.
Proximal bowel necrosis after high ligation of the inferior mesenteric artery in colorectal surgery. [2022]High ligation of the inferior mesenteric artery may jeopardize blood supply to the proximal bowel. We undertook this study to review the clinical features and outcomes of patients who developed proximal bowel necrosis after high ligation of the inferior mesenteric artery, and to assess the incidence and the risk factors for this complication.
Traumatic ileocolic pseudoaneurysm: diagnosis and transcatheter treatment. [2019]Injuries to branches of the superior mesenteric artery are unusual and often difficult to diagnose, yet require prompt recognition and treatment to prevent exsanguinating hemorrhage or bowel ischemia. This report describes a unique case of an ileocolic artery pseudoaneurysm diagnosed using delayed CT imaging and definitively treated by transcatheter embolization. Cathet. Cardiovasc. Intervent. 48:217-219, 1999.
Mesenteric Excision and Exclusion for Ileocolic Crohn's Disease: Feasibility and Safety of an Innovative, Combined Surgical Approach With Extended Mesenteric Excision and Kono-S Anastomosis. [2023]Ileocolic resection for Crohn's disease traditionally does not include a high ligation of the ileocolic pedicle, and most commonly is performed with a stapled side-to-side ileocolic anastomosis. The mesentery has recently been implicated in the pathophysiology of Crohn's disease. Two techniques have been developed and are associated with reduced postoperative recurrence: the Kono-S anastomosis that excludes diseased mesentery and extended mesenteric excision that resects diseased mesentery. We aimed to assess the technical feasibility and safety of a novel combination of techniques: mesenteric excision and exclusion.
Minimally invasive ileocecal valve resection in ileocecal Crohn's disease. [2023]Considering ileocolic resection as a surgical standard for the treatment of ileocecal valve Crohn's disease, we propose a limited resection of the terminal ileum and ileocecal valve with ileocecal anastomosis.
Laparoscopic intracorporeal ileocolic resection for Crohn's disease: is it safe? [2009]The aim of this study was to assess the impact of laparoscopic ileocolic resection with intracorporeal vascular division and anastomosis on the outcome of patients with terminal ileal Crohn's disease.
Influence of risk factors on the safety of ileocolic anastomosis in Crohn's disease surgery. [2022]Ileocecal resection is the most commonly performed operation in patients with Crohn's disease. Anastomotic-associated complications, with their associated morbidity, are the most feared risks of surgery.