MeSenteric SpAring Versus High Ligation Ileocolic Resection for the Prevention of REcurrent Crohn's DiseaSe (SPARES)

NCT04578392 | Terminated

• 1 other identifier: 20-139
• Study Type: interventional
• Target: 13
• Locations: 4 countries
• Sites: 7

Brief Summary

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

Conditions

Crohn Disease

Keywords

ileocolic resection; Crohn's disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  6 months, 1 year

• Endoscopic Recurrence - Rutgeert score

  1 year

• Surgical Recurrence

  1 and 5 years

Study Arms (2)

high ligation of ileocolic artery

ACTIVE COMPARATOR

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

Procedure: high ligation of ileocolic artery; Procedure: mesenteric sparing

mesenteric sparing for a primary ileocolic resection

ACTIVE COMPARATOR

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

Procedure: high ligation of ileocolic artery; Procedure: mesenteric sparing

Interventions

high ligation of ileocolic artery PROCEDURE

Patients will be randomized according to post-operative recurrence risk to surgery to high ligation or mesenteric sparing

high ligation of ileocolic artery; mesenteric sparing for a primary ileocolic resection

mesenteric sparing PROCEDURE

Patients will be randomized according to post-operative recurrence risk to surgery to high ligation or mesenteric sparing

high ligation of ileocolic artery; mesenteric sparing for a primary ileocolic resection

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (7)

Cedars-Sinai Hospital System

Los Angeles, California, 90048, United States

Location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Mt. Sinai

Toronto, Ontario, M5G 1X5, Canada

Location

Humanitas

Rozzano, Milano, 20089, Italy

Location

St Mark's Hospital and Academic Institution

Harrow, Middlesex, HA1 3UJ, United Kingdom

Location

Related Publications (21)

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• McLeod RS, Wolff BG, Ross S, Parkes R, McKenzie M; Investigators of the CAST Trial. Recurrence of Crohn's disease after ileocolic resection is not affected by anastomotic type: results of a multicenter, randomized, controlled trial. Dis Colon Rectum. 2009 May;52(5):919-27. doi: 10.1007/DCR.0b013e3181a4fa58.

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• Coffey CJ, Kiernan MG, Sahebally SM, Jarrar A, Burke JP, Kiely PA, Shen B, Waldron D, Peirce C, Moloney M, Skelly M, Tibbitts P, Hidayat H, Faul PN, Healy V, O'Leary PD, Walsh LG, Dockery P, O'Connell RP, Martin ST, Shanahan F, Fiocchi C, Dunne CP. Inclusion of the Mesentery in Ileocolic Resection for Crohn's Disease is Associated With Reduced Surgical Recurrence. J Crohns Colitis. 2018 Nov 9;12(10):1139-1150. doi: 10.1093/ecco-jcc/jjx187.

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  PMID: 16481630 RESULT

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Amy Lightner, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery in the Department of Colon and Rectal Surgery at Cleveland Clinic

Model Details: 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.

Study Record Dates

• First Submitted: October 1, 2020
• First Posted: October 8, 2020
• Study Start: July 28, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); US (4); CA (1); GB (1)