← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 and 5 years

Awards & highlights

SPARES Trial 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.Check my eligibility

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.See study design

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.

SPARES Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 18 and 65 years old.

Select...

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

Select...

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

SPARES Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Endoscopic recurrence based on Rutgeert scoring at the time of colonoscopy

Secondary outcome measures

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

Endoscopic Recurrence - Rutgeert score

Surgical Recurrence

SPARES 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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor

1,030 Previous Clinical Trials

1,365,377 Total Patients Enrolled

Amy Lightner, MD2.33 ReviewsPrincipal Investigator - The Cleveland Clinic

The Cleveland Clinic

18 Previous Clinical Trials

1,443 Total Patients Enrolled

5Patient Review

Dr. Lightner's excellent skillset saved my husband's life. We are incredibly grateful to her.

Media Library

High Ligation of Ileocolic Artery (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04578392 — N/A

Crohn's Disease Research Study Groups: mesenteric sparing for a primary ileocolic resection, high ligation of ileocolic artery

Crohn's Disease Clinical Trial 2023: High Ligation of Ileocolic Artery Highlights & Side Effects. Trial Name: NCT04578392 — N/A

High Ligation of Ileocolic Artery (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04578392 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial currently accept new participants?

"Data available on clinicaltrials.gov suggests that the aforementioned trial is currently in search of participants. The experiment was initially advertised on July 28th 2020 and its details were last modified on April 1st 2022."

Answered by AI

Are there many sites within the city where this trial is currently taking place?

"Prospective patients can find this trial at Cleveland Clinic in Ohio, Mt. Sinai in Toronto, Ontario, and the Cedars-Sinai Hospital System in Los Angeles with 5 other sites scattered throughout North America."

Answered by AI

Is the target age range for this clinical trial larger than 40 years?

"The age range for this medical trial is between 18 and 65. If a patient falls outside of these brackets, there are 69 trials available to patients under the age of 18 or 195 studies suitable for those over 65 years old."

Answered by AI

Are there any qualifications for participation in this experiment?

"This medical research is searching for 181 individuals aged between 18 and 65 with ileocolitis. Eligibility criteria include: gender, age range, length of Crohn's disease in ileocolic area, concurrent treatment with corticosteroids and other drugs such as 5-ASA medications, thiopurines, MTX antibiotics etc., compliance to the protocol rules and regulations, capacity to provide written consent without coercion or undue influence, medically intractable illness or allergic reaction/intolerance towards conventional therapeutic approaches."

Answered by AI

What is the aggregate number of participants actively engaged in this clinical trial?

"Affirmative. The clinicaltrials.gov database implies that this medical trial is currently in need of participants; it was first listed on July 28th 2020 and the most recent amendment was made April 1st 2022. 181 subjects are required from five different research facilities."

Answered by AI

Recent research and studies

GutJournal

Natural Course of Crohn's Disease After Ileocolic Resection: Endoscopically Visualised Ileal Ulcers Preceding Symptoms.

Olaison, G, K Smedh, and R Sjodahl. 1992. “Natural Course of Crohn's Disease After Ileocolic Resection: Endoscopically Visualised Ileal Ulcers Preceding Symptoms.”. Gut. BMJ. doi:10.1136/gut.33.3.331.

GutJournal

Surgery for Adult Crohn's Disease: What Is the Actual Risk?

Bouguen, G., and L. Peyrin-Biroulet. 2011. “Surgery for Adult Crohn's Disease: What Is the Actual Risk?”. Gut. BMJ. doi:10.1136/gut.2010.234617.

Surgical EndoscopyJournal

Laparoscopically Assisted Intestinal Resection in 88 Patients with Crohn’s Disease

Canin-Endres, J., B. Salky, F. Gattorno, and M. Edye. 1999. “Laparoscopically Assisted Intestinal Resection in 88 Patients with Crohn’s Disease”. Surgical Endoscopy. Springer Science and Business Media LLC. doi:10.1007/s004649901049.

Diseases of the Colon & RectumJournal