Crohn DiseaseSPARESNCT04578392
MeSenteric SpAring Versus High Ligation Ileocolic Resection for the Prevention of REcurrent Crohn's DiseaSe (SPARES)
A study testing high ligation of ileocolic artery and mesenteric sparing in people with Crohn Disease, run by The Cleveland Clinic at 7 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- high ligation of ileocolic artery and mesenteric sparing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 28 Jul 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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.
- Specific exclusions; Evidence of hepatitis B, C, or HIV
- 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
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
United States4 sites
Cleveland Clinic
Cleveland, Ohio, 44195
Cedars-Sinai Hospital System
Los Angeles, California, 90048
Stanford University School of Medicine
Stanford, California, 94305
Cleveland Clinic Florida
Weston, Florida, 33331
United Kingdom1 site
St Mark's Hospital and Academic Institution
Harrow, Middlesex, HA1 3UJ
About this study
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
Read more
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
Read the detailed description
There is increasing evidence to suggest that the mesentery may play an active role in the pathophysiology of Crohn's disease. There is significant clinical, endoscopic, and surgical recurrence of disease following ileocolic resection at the site of the anastomosis. The study is seeking to understand if the mesentery plays a role in recurrence following ileocolic resection.
Crohn's disease (CD) is a chronic inflammatory disease of the intestinal tract with an unknown etiology and an unknown cure. The characteristic transmural inflammation can progress to refractory inflammatory disease, stricturing disease, and fistulizing disease - all potential indications for surgery when medical management has been exhausted. An important tenant to remember is that surgery is not curative but is rather an adjunct to maximal medical therapy.
One third of patients with Crohn's disease (CD) will require a major abdominal resection within 5 years of their diagnosis, and two-thirds will ultimately require operative management at least once during the course of their disease.
Unfortunately, surgery for Crohn's disease (CD) is not curative and disease recurrence is common with 62% having endoscopic recurrence at six months, and 80% and 30% of patients having endoscopic and clinical recurrence, respectively, at one year. A third of these patients will require a reoperation at 10 years and up to 80% will require an additional operation by 15 years.This undoubtedly leads to an increased probability of malabsorption syndrome and decreased quality of life.
A significant volume of research has been conducted in attempt to determine how to prevent postoperative recurrence of CD following an ileocolic resection. Some studies have focused on the timing of resuming postoperative medical therapy. Others have looked at surgical technique at the time of ileocolic resection including anatomic configuration of the anastomosis and performing a stapled versus handsewn anastomosis. Various configurations include a side to side anastomosis, end to end, and Kono-S anastomosis. A randomized clinical trial compared a side to side versus an end to end, and found endoscopic recurrence rates were similar in the two groups (42.5% versus 37.9%) at a mean follow up of 11.9 months. A later multi-institution international trial of the Kono S anastomosis determined that the anastomosis was associated with a decreased surgical recurrence rate as compared to conventional anastomoses; 5 and 10 year surgical recurrence-free survival was 98.6%.15 Several Cochrane Database reviews have reported no difference in a stapled versus handsewn anastomosis for an ileocolic resection. Therefore, other than the potential decreased recurrence with the Kono-S anastomosis, no other surgical techniques have altered the postoperative recurrence rate of CD following an ileocolic resection.
Interestingly there is recent evidence to suggest that CD may be a disease of the mesentery rather than just the mucosa of the bowel alone. In CD, the transmural inflammation facilitates increased bacterial translocation into the creeping fat. These translocating antigens and activate adipocytes which are cells than have complex metabolic and immunologic functions. Additionally, it is thought that functional abnormalities in the mesenteric structures exert an inflammatory effect: the secretion of adipokines that have endocrine functions contribute to immunomodulation through a response to afferent signals, neuropeptides, and functional cytokines; mesenteric nerves are involved in the pathogenesis through neuropeptides; and lymphatics in the mesentery may obstruct, remodel, and impair contraction, contributing to the irregularly thickened mesentery seen in CD. Interestingly, the interaction between neuropeptides, adipokines, and vascular and lymphatic endothelia leads to adipose tissue remodeling. This makes the mesentery an active participant in CD, seemingly as much as the bowel itself. However, the mesentery is typically spared, or left in situ, during resection for CD, unlike resections for adenocarinocma of the colon. In adenocarcinoma, a 'high ligation' is performed, where the feeding vessel is taken at its origin in order to take sufficient mesentery and lymph nodes with the colon specimen. However, in operations for CD, the mesentery is spared and typically taken close to the bowel wall despite enlarged lymph nodes and thickened diseased mesentery. A high ligation of the ileocolic artery in order to sample an increased volume of mesentery and lymph nodes to prevent postoperative CD has never been evaluated in a randomized control trial. A recent retrospective study comparing surgical recurrence following a mesenteric sparing versus mesenteric resection approach with ileocecal resection found cumulative reoperation rates were significantly lower in the mesenteric resection group (40% versus 2.9%; p=0.003).
The endoscopic recurrence of CD typically precedes clinical symptoms, and the severity of lesions can predict the subsequent symptomatic course of the disease. Over a four year follow-up period, 100% of patients with severe endoscopic recurrence (Rutgeerts score of i2-i4) developed symptomatic recurrence compared to only 9% of patients with a low score (i0-i1). With such a high rate of endoscopic recurrence, it is thought that post-surgical evaluation should be performed at six months rather than one year when considering adequate early treatment.
- Conditions
- Crohn Disease
- Being tested
- high ligation of ileocolic artery, mesenteric sparing
- Keywords
- ileocolic resection, Crohn's disease
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high ligation of ileocolic arteryProcedure or surgery
Patients will be randomized according to post-operative recurrence risk to surgery to high ligation or mesenteric sparing
mesenteric sparingProcedure or surgery
Patients will be randomized according to post-operative recurrence risk to surgery to high ligation or mesenteric sparing
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: high ligation of ileocolic artery; Procedure: mesenteric sparing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
Clinical Recurrence - Crohn's Disease Activity Index (CDAI)
Clinical Recurrence is defined as an increase in CDAI >100 or CDAI >150
This tool used to quantify the symptoms of patients with Crohn's disease in order to define response or remission of disease. Remission of Crohn's disease is defined as CDAI below 150. Severe disease was defined as a value of greater than 450. Most major research studies on medications in Crohn's disease define response as a fall of the CDAI of greater than 70 points. (score ranges form 0 to over 600, the higher the score, the higher the disease state)
Measured: 6 months, 1 year
Endoscopic Recurrence - Rutgeert score
Endoscopic recurrence is define as a 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.
Measured: 1 year
Surgical Recurrence
Surgical recurrence is define as need for repeat ileocolic resection due to recurrence at anastomotic site
Measured: 1 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start28 Jul 2020
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Why it stopped: PI left Cleveland Clinic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model 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.
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony Lembo, The Cleveland Clinic
- Investigators
- Amy Lightner, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04578392
- Sponsor's protocol ID
- 20-139
- Acronym
- SPARES
- Status last verified
- Apr 2026
- First submitted
- 1 Oct 2020
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bernell O, Lapidus A, Hellers G. Risk factors for surgery and postoperative recurrence in Crohn's disease. Ann Surg. 2000 Jan;231(1):38-45. doi: 10.1097/00000658-200001000-00006.
PubMed 10636100Bouguen G, Peyrin-Biroulet L. Surgery for adult Crohn's disease: what is the actual risk? Gut. 2011 Sep;60(9):1178-81. doi: 10.1136/gut.2010.234617. Epub 2011 May 24. No abstract available.
PubMed 21610273Peyrin-Biroulet L, Oussalah A, Williet N, Pillot C, Bresler L, Bigard MA. Impact of azathioprine and tumour necrosis factor antagonists on the need for surgery in newly diagnosed Crohn's disease. Gut. 2011 Jul;60(7):930-6. doi: 10.1136/gut.2010.227884. Epub 2011 Jan 12.
PubMed 21228429Canin-Endres J, Salky B, Gattorno F, Edye M. Laparoscopically assisted intestinal resection in 88 patients with Crohn's disease. Surg Endosc. 1999 Jun;13(6):595-9. doi: 10.1007/s004649901049.
PubMed 10347299Mekhjian HS, Switz DM, Watts HD, Deren JJ, Katon RM, Beman FM. National Cooperative Crohn's Disease Study: factors determining recurrence of Crohn's disease after surgery. Gastroenterology. 1979 Oct;77(4 Pt 2):907-13. No abstract available.
PubMed 467942Lewis RT, Maron DJ. Efficacy and complications of surgery for Crohn's disease. Gastroenterol Hepatol (N Y). 2010 Sep;6(9):587-96.
PubMed 21088749Lazarev M, Ullman T, Schraut WH, Kip KE, Saul M, Regueiro M. Small bowel resection rates in Crohn's disease and the indication for surgery over time: experience from a large tertiary care center. Inflamm Bowel Dis. 2010 May;16(5):830-5. doi: 10.1002/ibd.21118.
PubMed 19798731Orlando A, Mocciaro F, Renna S, Scimeca D, Rispo A, Lia Scribano M, Testa A, Aratari A, Bossa F, Tambasco R, Angelucci E, Onali S, Cappello M, Fries W, D'Inca R, Martinato M, Castiglione F, Papi C, Annese V, Gionchetti P, Rizzello F, Vernia P, Biancone L, Kohn A, Cottone M. Early post-operative endoscopic recurrence in Crohn's disease patients: data from an Italian Group for the study of inflammatory bowel disease (IG-IBD) study on a large prospective multicenter cohort. J Crohns Colitis. 2014 Oct;8(10):1217-21. doi: 10.1016/j.crohns.2014.02.010. Epub 2014 Mar 11.
PubMed 24630485Olaison G, Smedh K, Sjodahl R. Natural course of Crohn's disease after ileocolic resection: endoscopically visualised ileal ulcers preceding symptoms. Gut. 1992 Mar;33(3):331-5. doi: 10.1136/gut.33.3.331.
PubMed 1568651Rutgeerts PJ. From aphthous ulcer to full-blown Crohn's disease. Dig Dis. 2011;29(2):211-4. doi: 10.1159/000323922. Epub 2011 Jul 5.
PubMed 21734386Michelassi F, Balestracci T, Chappell R, Block GE. Primary and recurrent Crohn's disease. Experience with 1379 patients. Ann Surg. 1991 Sep;214(3):230-8; discussion 238-40. doi: 10.1097/00000658-199109000-00006.
PubMed 1929605Rutgeerts P. Strategies in the prevention of post-operative recurrence in Crohn's disease. Best Pract Res Clin Gastroenterol. 2003 Feb;17(1):63-73. doi: 10.1053/bega.2002.0358.
PubMed 12617883McLeod 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.
PubMed 19502857Kono T, Fichera A, Maeda K, Sakai Y, Ohge H, Krane M, Katsuno H, Fujiya M. Kono-S Anastomosis for Surgical Prophylaxis of Anastomotic Recurrence in Crohn's Disease: an International Multicenter Study. J Gastrointest Surg. 2016 Apr;20(4):783-90. doi: 10.1007/s11605-015-3061-3. Epub 2015 Dec 22.
PubMed 26696531Neutzling CB, Lustosa SA, Proenca IM, da Silva EM, Matos D. Stapled versus handsewn methods for colorectal anastomosis surgery. Cochrane Database Syst Rev. 2012 Feb 15;2012(2):CD003144. doi: 10.1002/14651858.CD003144.pub2.
PubMed 22336786
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MeSenteric SpAring Versus High Ligation Ileocolic Resection for the Prevention of REcurrent Crohn's DiseaSe (SPARES)
- ClinicalTrials.gov ID
- NCT04578392
- Acronym / sponsor ID
- SPARES / 20-139
- Conditions
- Crohn Disease
- Keywords
- ileocolic resection, Crohn's disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left Cleveland Clinic
- Enrolment
- 13 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 28 Jul 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
There is increasing evidence to suggest that the mesentery may play an active role in the pathophysiology of Crohn's disease. There is significant clinical, endoscopic, and surgical recurrence of disease following ileocolic resection at the site of the anastomosis. The study is seeking to understand if the mesentery plays a role in recurrence following ileocolic resection.
Crohn's disease (CD) is a chronic inflammatory disease of the intestinal tract with an unknown etiology and an unknown cure. The characteristic transmural inflammation can progress to refractory inflammatory disease, stricturing disease, and fistulizing disease - all potential indications for surgery when medical management has been exhausted. An important tenant to remember is that surgery is not curative but is rather an adjunct to maximal medical therapy.
One third of patients with Crohn's disease (CD) will require a major abdominal resection within 5 years of their diagnosis, and two-thirds will ultimately require operative management at least once during the course of their disease.
Unfortunately, surgery for Crohn's disease (CD) is not curative and disease recurrence is common with 62% having endoscopic recurrence at six months, and 80% and 30% of patients having endoscopic and clinical recurrence, respectively, at one year. A third of these patients will require a reoperation at 10 years and up to 80% will require an additional operation by 15 years.This undoubtedly leads to an increased probability of malabsorption syndrome and decreased quality of life.
A significant volume of research has been conducted in attempt to determine how to prevent postoperative recurrence of CD following an ileocolic resection. Some studies have focused on the timing of resuming postoperative medical therapy. Others have looked at surgical technique at the time of ileocolic resection including anatomic configuration of the anastomosis and performing a stapled versus handsewn anastomosis. Various configurations include a side to side anastomosis, end to end, and Kono-S anastomosis. A randomized clinical trial compared a side to side versus an end to end, and found endoscopic recurrence rates were similar in the two groups (42.5% versus 37.9%) at a mean follow up of 11.9 months. A later multi-institution international trial of the Kono S anastomosis determined that the anastomosis was associated with a decreased surgical recurrence rate as compared to conventional anastomoses; 5 and 10 year surgical recurrence-free survival was 98.6%.15 Several Cochrane Database reviews have reported no difference in a stapled versus handsewn anastomosis for an ileocolic resection. Therefore, other than the potential decreased recurrence with the Kono-S anastomosis, no other surgical techniques have altered the postoperative recurrence rate of CD following an ileocolic resection.
Interestingly there is recent evidence to suggest that CD may be a disease of the mesentery rather than just the mucosa of the bowel alone. In CD, the transmural inflammation facilitates increased bacterial translocation into the creeping fat. These translocating antigens and activate adipocytes which are cells than have complex metabolic and immunologic functions. Additionally, it is thought that functional abnormalities in the mesenteric structures exert an inflammatory effect: the secretion of adipokines that have endocrine functions contribute to immunomodulation through a response to afferent signals, neuropeptides, and functional cytokines; mesenteric nerves are involved in the pathogenesis through neuropeptides; and lymphatics in the mesentery may obstruct, remodel, and impair contraction, contributing to the irregularly thickened mesentery seen in CD. Interestingly, the interaction between neuropeptides, adipokines, and vascular and lymphatic endothelia leads to adipose tissue remodeling. This makes the mesentery an active participant in CD, seemingly as much as the bowel itself. However, the mesentery is typically spared, or left in situ, during resection for CD, unlike resections for adenocarinocma of the colon. In adenocarcinoma, a 'high ligation' is performed, where the feeding vessel is taken at its origin in order to take sufficient mesentery and lymph nodes with the colon specimen. However, in operations for CD, the mesentery is spared and typically taken close to the bowel wall despite enlarged lymph nodes and thickened diseased mesentery. A high ligation of the ileocolic artery in order to sample an increased volume of mesentery and lymph nodes to prevent postoperative CD has never been evaluated in a randomized control trial. A recent retrospective study comparing surgical recurrence following a mesenteric sparing versus mesenteric resection approach with ileocecal resection found cumulative reoperation rates were significantly lower in the mesenteric resection group (40% versus 2.9%; p=0.003).
The endoscopic recurrence of CD typically precedes clinical symptoms, and the severity of lesions can predict the subsequent symptomatic course of the disease. Over a four year follow-up period, 100% of patients with severe endoscopic recurrence (Rutgeerts score of i2-i4) developed symptomatic recurrence compared to only 9% of patients with a low score (i0-i1). With such a high rate of endoscopic recurrence, it is thought that post-surgical evaluation should be performed at six months rather than one year when considering adequate early treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model 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.
| Arm | Type | Receives |
|---|---|---|
| high ligation of ileocolic artery | Active comparator | Procedure: high ligation of ileocolic artery, Procedure: mesenteric sparingRandomized 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 |
| mesenteric sparing for a primary ileocolic resection | Active comparator | Procedure: high ligation of ileocolic artery, Procedure: mesenteric sparingRandomized 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high ligation of ileocolic arteryPatients will be randomized according to post-operative recurrence risk to surgery to high ligation or mesenteric sparing | Procedure or surgery | high ligation of ileocolic artery, mesenteric sparing for a primary ileocolic resection |
| mesenteric sparingPatients will be randomized according to post-operative recurrence risk to surgery to high ligation or mesenteric sparing | Procedure or surgery | high ligation of ileocolic artery, mesenteric sparing for a primary ileocolic resection |
Primary outcome
Endoscopic recurrence based on Rutgeert scoring at the time of colonoscopy
Time frame: 6 months
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.
3 secondary outcomes
Clinical Recurrence - Crohn's Disease Activity Index (CDAI)
Time frame: 6 months, 1 year
Endoscopic Recurrence - Rutgeert score
Time frame: 1 year
Surgical Recurrence
Time frame: 1 and 5 years
Results and safety
The study was stopped early (reason given: PI left Cleveland Clinic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Background: PubMed 10636100Bernell O, Lapidus A, Hellers G. Risk factors for surgery and postoperative recurrence in Crohn's disease. Ann Surg. 2000 Jan;231(1):38-45. doi: 10.1097/00000658-200001000-00006.
- Background: PubMed 21610273Bouguen G, Peyrin-Biroulet L. Surgery for adult Crohn's disease: what is the actual risk? Gut. 2011 Sep;60(9):1178-81. doi: 10.1136/gut.2010.234617. Epub 2011 May 24. No abstract available.
- Background: PubMed 21228429Peyrin-Biroulet L, Oussalah A, Williet N, Pillot C, Bresler L, Bigard MA. Impact of azathioprine and tumour necrosis factor antagonists on the need for surgery in newly diagnosed Crohn's disease. Gut. 2011 Jul;60(7):930-6. doi: 10.1136/gut.2010.227884. Epub 2011 Jan 12.
- Background: PubMed 10347299Canin-Endres J, Salky B, Gattorno F, Edye M. Laparoscopically assisted intestinal resection in 88 patients with Crohn's disease. Surg Endosc. 1999 Jun;13(6):595-9. doi: 10.1007/s004649901049.
- Background: PubMed 467942Mekhjian HS, Switz DM, Watts HD, Deren JJ, Katon RM, Beman FM. National Cooperative Crohn's Disease Study: factors determining recurrence of Crohn's disease after surgery. Gastroenterology. 1979 Oct;77(4 Pt 2):907-13. No abstract available.
- Background: PubMed 21088749Lewis RT, Maron DJ. Efficacy and complications of surgery for Crohn's disease. Gastroenterol Hepatol (N Y). 2010 Sep;6(9):587-96.
- Background: PubMed 19798731Lazarev M, Ullman T, Schraut WH, Kip KE, Saul M, Regueiro M. Small bowel resection rates in Crohn's disease and the indication for surgery over time: experience from a large tertiary care center. Inflamm Bowel Dis. 2010 May;16(5):830-5. doi: 10.1002/ibd.21118.
- Background: PubMed 24630485Orlando A, Mocciaro F, Renna S, Scimeca D, Rispo A, Lia Scribano M, Testa A, Aratari A, Bossa F, Tambasco R, Angelucci E, Onali S, Cappello M, Fries W, D'Inca R, Martinato M, Castiglione F, Papi C, Annese V, Gionchetti P, Rizzello F, Vernia P, Biancone L, Kohn A, Cottone M. Early post-operative endoscopic recurrence in Crohn's disease patients: data from an Italian Group for the study of inflammatory bowel disease (IG-IBD) study on a large prospective multicenter cohort. J Crohns Colitis. 2014 Oct;8(10):1217-21. doi: 10.1016/j.crohns.2014.02.010. Epub 2014 Mar 11.
- Background: PubMed 1568651Olaison G, Smedh K, Sjodahl R. Natural course of Crohn's disease after ileocolic resection: endoscopically visualised ileal ulcers preceding symptoms. Gut. 1992 Mar;33(3):331-5. doi: 10.1136/gut.33.3.331.
- Background: PubMed 21734386Rutgeerts PJ. From aphthous ulcer to full-blown Crohn's disease. Dig Dis. 2011;29(2):211-4. doi: 10.1159/000323922. Epub 2011 Jul 5.
- Background: PubMed 1929605Michelassi F, Balestracci T, Chappell R, Block GE. Primary and recurrent Crohn's disease. Experience with 1379 patients. Ann Surg. 1991 Sep;214(3):230-8; discussion 238-40. doi: 10.1097/00000658-199109000-00006.
- Background: PubMed 12617883Rutgeerts P. Strategies in the prevention of post-operative recurrence in Crohn's disease. Best Pract Res Clin Gastroenterol. 2003 Feb;17(1):63-73. doi: 10.1053/bega.2002.0358.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy Lightner, MD principal investigator
The Cleveland Clinic
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high ligation of ileocolic artery and mesenteric sparing in people with Crohn Disease, run by The Cleveland Clinic at 7 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada, Italy, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI left Cleveland Clinic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endoscopic recurrence based on Rutgeert scoring at the time of colonoscopy (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04578392, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.