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Procedure

Surgical Techniques for Crohn's Disease (SPARES Trial)

N/A

Recruiting

Led By Amy Lightner, MD

Research Sponsored by The Cleveland Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Males and females 18-65 years of age.

Medically refractory disease or inability to tolerate ongoing medical therapy

Must not have

Emergent indication for an operation

Patients who are undergoing an ileal resection only (NOT ileocecal) because the disease spares the distal most aspect of ileum and ileocecal valve

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 and 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare two operative techniques for patients with Crohn's disease who are undergoing a primary ileocecal resection. The primary endpoint is 6-month endoscopic recurrence.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects aren't specified but may include typical risks associated with abdominal surgery such as infection, bleeding, pain at incision site, bowel obstruction due to scar tissue formation (adhesions), and complications from anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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My condition hasn't improved with current treatment or I can't tolerate it.

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My Crohn's disease affects less than 30 cm of my ileocolic region.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need surgery urgently.

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I am having surgery to remove part of my small intestine, but not the valve connecting it to the large intestine.

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I am having a second surgery to remove part of my small intestine and colon.

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I need more than just ileocolic resection surgery due to additional disease locations.

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My surgery included creating a temporary opening for waste (ileostomy).

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I have more than 30 cm of disease in the last part of my small intestine.

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I am under 18 years old.

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I have a history of autoimmune diseases, but not Crohn's disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 and 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 and 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Endoscopic recurrence based on Rutgeert scoring at the time of colonoscopy

Secondary study objectives

Clinical Recurrence - Crohn's Disease Activity Index (CDAI)

Endoscopic Recurrence - Rutgeert score

Surgical Recurrence

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

0 / 11Eligibility criteria met