181 Participants Needed

Surgical Techniques for Crohn's Disease

(SPARES Trial)

Recruiting at 6 trial locations
CM
KE
AV
AB
Overseen ByAllison Bayles, AA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: The Cleveland Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

AL

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

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.
Ability to comply with protocol
See 2 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.
See 11 more

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)

Treatment Details

Interventions

  • High Ligation of Ileocolic Artery
  • Mesenteric Sparing
Trial Overview 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.
Participant Groups
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

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials
1,072
Recruited
1,377,000+

Findings from Research

In a study of 75 patients undergoing ileocecal resection or anterior rectal resection, high ligation of the inferior mesenteric artery was found to significantly prolong blood flow time in the sigmoid colon, indicating potential hypoperfusion issues.
Despite the differences in vascular perfusion, the rates of anastomotic leakage were similar between high and low ligation techniques, suggesting that low vascular perfusion may not be a definitive risk factor for leakage.
High Ligation of the Inferior Mesenteric Artery Induces Hypoperfusion of the Sigmoid Colon Stump During Anterior Resection.Higashijima, J., Kono, T., Shimada, M., et al.[2021]
Laparoscopic-assisted ileocolic resection for Crohn's disease is a safe and feasible procedure, as demonstrated by the uneventful postoperative course of a 32-year-old patient.
A rare complication, a mesenteric pseudoaneurysm, was identified post-surgery, likely due to the patient's thick vascular mesentery, highlighting the need for awareness of this potential risk in similar cases.
Endovascular treatment of ileocolic pseudoaneurysm after a laparoscopic-assisted bowel resection for Crohn disease.Edden, Y., Shussman, N., Cohen, MJ., et al.[2016]
In a study of 104 rectal cancer patients, precision low inferior mesenteric artery (IMA) ligation with left colonic artery (LCA) preservation led to a significant increase in the number of harvested lymph nodes compared to traditional high IMA ligation (24.9 vs. 16.9 nodes).
The precision technique also resulted in fewer postoperative complications (5.8% vs. 9.6%) while maintaining safety, as there were no significant differences in operative time or other recovery metrics between the two surgical methods.
[Accurate low ligation of inferior mesenteric artery and root lymph node dissection according to different vascular typing in laparoscopic radical resection of rectal cancer].Zhou, J., Zhang, S., Huang, J., et al.[2018]

References

High Ligation of the Inferior Mesenteric Artery Induces Hypoperfusion of the Sigmoid Colon Stump During Anterior Resection. [2021]
Endovascular treatment of ileocolic pseudoaneurysm after a laparoscopic-assisted bowel resection for Crohn disease. [2016]
[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]
Randomized clinical trial of high versus low inferior mesenteric artery ligation during anterior resection for rectal cancer. [2022]
A clinical study of inferior mesenteric artery typing in laparoscopic radical resections with left colonic artery preservation of rectal cancer. [2022]
Ileal long-segment ischemia after the unintended ligation of variant ileal branch during laparoscopic right hemicolectomy. [2022]
Proximal bowel necrosis after high ligation of the inferior mesenteric artery in colorectal surgery. [2022]
Traumatic ileocolic pseudoaneurysm: diagnosis and transcatheter treatment. [2019]
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]
Minimally invasive ileocecal valve resection in ileocecal Crohn's disease. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Laparoscopic intracorporeal ileocolic resection for Crohn's disease: is it safe? [2009]
12.United Statespubmed.ncbi.nlm.nih.gov
Influence of risk factors on the safety of ileocolic anastomosis in Crohn's disease surgery. [2022]
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