Surgical Techniques for Crohn's Disease

(SPARES Trial)

Recruiting at 6 trial locations

Overseen By Allison Bayles, AA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Disqualifiers: Repeat resection, Other disease locations, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

181 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two surgical techniques to determine which better reduces Crohn's disease symptoms post-surgery. It focuses on adults with Crohn's disease affecting the last part of the small intestine, unresponsive to medication. The study compares high ligation of the ileocolic artery (tightening of a specific artery) to a tissue-sparing technique. Individuals with Crohn's disease affecting less than 30 cm of their intestine, who haven't found relief from medication, might be suitable candidates. The trial will assess disease recurrence six months after surgery and conduct follow-ups for a total of five years. As an unphased trial, it offers patients the chance to contribute to innovative surgical research that could enhance future treatment options.

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 prior data suggests that these surgical techniques are safe for Crohn's disease patients?

Research has shown that both surgical methods—high ligation of the ileocolic artery and mesenteric sparing—are generally well-tolerated. High ligation involves removing a section of blood vessels and reduces the early return of Crohn's disease in the intestines. Studies have demonstrated the safety of this technique.

Mesenteric sparing, in contrast, preserves more of the mesentery, the tissue that holds the intestines in place. Research indicates that this method can lead to similar or even fewer complications after surgery compared to traditional methods, confirming its safety for patients.

Overall, both techniques have been studied sufficiently to confirm their safety for those considering surgery for Crohn's disease. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these surgical techniques for Crohn's Disease because they offer new ways to perform ileocolic resections, potentially improving patient outcomes. The high ligation of the ileocolic artery is a technique that involves tying off this artery higher up, which could reduce complications like bleeding. Mesenteric sparing, on the other hand, preserves more of the mesentery, the tissue that supports the intestines, which might lead to faster recovery and fewer long-term issues. These approaches could provide alternatives to the current standard surgeries by minimizing invasive impacts and enhancing recovery.

What evidence suggests that these surgical techniques are effective for Crohn's disease?

This trial will compare two surgical methods to prevent Crohn's disease from returning after surgery. One method involves removing the mesentery, a fold of tissue that connects the intestine to the abdominal wall. Reports suggest this approach might reduce the chance of the disease returning by about 37%. The other method, called high ligation, involves tying off the artery that supplies blood to the affected area. Some studies have found this method safe, but risks include the formation of bulging blood vessels. Both techniques aim to improve patient outcomes by reducing the likelihood of Crohn's disease returning after surgery. ^{2 3 4 6 7}

Who Is on the Research Team?

Amy Lightner, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

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

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: mesenteric sparing for a primary ileocolic resection Active Control 2 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 artery Active Control 2 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

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Published Research Related to This Trial

A limited resection of the terminal ileum and ileocecal valve, followed by ileocecal anastomosis, was successfully performed on three patients with Crohn's disease, resulting in symptom resolution and no mucosal changes at 6 and 12 months post-surgery.

This approach minimizes the extent of surgery compared to standard ileocolic resection, potentially reducing the risk of post-surgical relapses and preserving more of the bowel, making it a viable alternative for select patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimally invasive ileocecal valve resection in ileocecal Crohn's disease. Benassai, G., Serra, C., Romeo, G., et al.[2023]

In a study of 207 patients undergoing ileocecal or ileocolic resections for Crohn's disease, steroid use and preoperative abscess formation were identified as significant independent risk factors for anastomotic complications, with complication rates reaching 40% when both factors were present.

The overall risk of anastomotic complications was 6% in patients without these risk factors, but increased to 14% with one risk factor, highlighting the importance of assessing these conditions before surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of risk factors on the safety of ileocolic anastomosis in Crohn's disease surgery. Tzivanakis, A., Singh, JC., Guy, RJ., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[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]

In a study of 92 rectal cancer patients undergoing laparoscopic radical resection, type III inferior mesenteric artery (IMA) was associated with significantly higher intraoperative blood loss and a greater incidence of postoperative anastomotic fistula compared to type I and II IMAs.

Despite the increased bleeding and fistula rates in type III IMA patients, the overall risk of postoperative complications did not differ significantly among the three IMA types, suggesting that while type III may pose specific challenges, it does not lead to a higher overall complication rate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A clinical study of inferior mesenteric artery typing in laparoscopic radical resections with left colonic artery preservation of rectal cancer. Chen, J., Wang, M., Chen, Y., et al.[2022]

A novel surgical technique combining mesenteric excision and exclusion was performed on 22 patients with ileocolic Crohn's disease, showing high feasibility and safety with no cases of intra-abdominal sepsis or anastomotic leak.

The median postoperative stay was only 4 days, and while there were 2 readmissions for reintervention, the overall outcomes suggest this approach could potentially reduce postoperative recurrence of Crohn's disease, warranting further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Holubar, SD., Gunter, RL., Click, BH., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 80 patients undergoing laparoscopic ileocolic resection for terminal ileal Crohn's disease, the procedure had a low conversion rate of 1.2% and a complication rate of only 7.5%, indicating it is a safe surgical option.

The surgery resulted in a recurrence rate of 30% over a median follow-up of 64 months, suggesting that while effective, some patients may experience a return of symptoms after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laparoscopic intracorporeal ileocolic resection for Crohn's disease: is it safe? Bergamaschi, R., Haughn, C., Reed, JF., et al.[2009]

A rare case of ileal ischemia occurred due to the unintentional ligation of a variant ileal branch of the superior mesenteric artery during laparoscopic surgery, highlighting the risk of confusing this branch with the ileocolic artery.

The use of intraoperative real-time monitoring techniques, such as indocyanine green (ICG) angiography and hyperspectral imaging (HSI), can effectively detect hypoperfusion and potentially prevent complications related to inadequate blood supply during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ileal long-segment ischemia after the unintended ligation of variant ileal branch during laparoscopic right hemicolectomy. Son, GM., Kim, TU., Shin, DH., et al.[2022]

In a study of 409 patients undergoing high or low ligation for sigmoid colon and rectal cancer, 2.0% of those who had high ligation developed proximal bowel necrosis, a serious complication that required secondary surgery.

Advanced age, cerebrovascular disease, and hypertension were identified as significant risk factors for developing proximal bowel necrosis, with cerebrovascular disease being an independent predictor of this complication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proximal bowel necrosis after high ligation of the inferior mesenteric artery in colorectal surgery. Tsujinaka, S., Kawamura, YJ., Tan, KY., et al.[2022]

In a randomized trial involving 331 patients with rectal cancer, the method of inferior mesenteric artery ligation (high tie vs. low tie) did not significantly affect the incidence of anastomotic leakage, with rates of 17.7% for high tie and 16.3% for low tie.

There were no significant differences in overall survival (87.2% vs. 89.4%) or disease-free survival (76.3% vs. 77.6%) at 5 years between the two ligation methods, indicating that the choice of ligation level does not impact long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized clinical trial of high versus low inferior mesenteric artery ligation during anterior resection for rectal cancer. Fujii, S., Ishibe, A., Ota, M., et al.[2022]

The case report highlights a rare instance of an ileocolic artery pseudoaneurysm, which is a serious condition that can lead to severe bleeding or bowel ischemia if not promptly diagnosed and treated.

The diagnosis was successfully made using delayed CT imaging, and the condition was effectively treated through transcatheter embolization, demonstrating a minimally invasive approach to managing such vascular injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Traumatic ileocolic pseudoaneurysm: diagnosis and transcatheter treatment. Rundback, JH., Chughtai, S., Rozenblit, G., et al.[2019]

Citations

1. clinicaltrials.stanford.edu clinicaltrials.stanford.edu/trials/m/NCT04578392.html

MeSenteric SpAring Versus High Ligation Ileocolic Resection ... Patients will be randomized according to post-operative recurrence risk to either a high ligation of ileocolic artery or mesenteric sparing ileocolic resection.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9365471/

Intriguing Role of the Mesentery in Ileocolic Crohn's Disease It was suggested that excision of the mesentery may reduce immunological activity and eventually surgical recurrence rates. Histological ...

3. withpower.com withpower.com/trial/phase-crohn-disease-6-2020-04e78

Surgical Techniques for Crohn's Disease (SPARES Trial) The surgical technique, including high ligation of the ileocolic artery, is generally considered safe, but there are potential risks such as pseudoaneurysms ( ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03172143

Mesenteric Sparing for the Prevention of Recurrent Crohn's ... A significant volume of research has been conducted in attempt to determine how to prevent postoperative recurrence of CD following an ileocolic resection. Some ...

5. trial.medpath.com trial.medpath.com/clinical-trial/8b11ac9dac8e9384/nct04578392-mesenteric-sparing-vs-high-ligation-ileocolic-resection

MeSenteric SpAring Versus High Ligation Ileocolic Resection ... Study description - Patients will be randomized according to post-operative recurrence risk to either a high ligation of ileocolic artery or mesenteric sparing ...

6. stanfordhealthcare.org stanfordhealthcare.org/trials/m/NCT04578392.html

MeSenteric SpAring Versus High Ligation Ileocolic ... Purpose. Study description - Patients will be randomized according to post-operative recurrence risk to either a high ligation of ileocolic artery or ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1091255X25002215

Recurrence in Crohn's disease: the impact of surgical ... ... mesenteric resection with high ligation of the ileocolic vessels can reduce early mucosal recurrence. Several RCTs are underway to evaluate ...