Surgical Techniques for Crohn's Disease

Overseen By Koianka Ivanova-Trencheva, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Under 18, Pregnant, Non-English speakers, others

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

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how two surgical techniques for Crohn's disease affect gut bacteria and the immune system. Researchers aim to determine if differences exist between the Kono-S procedure (KSa) and side-to-side anastomosis (SSa) in these areas. Suitable candidates include those with Crohn's ileitis or ileocolitis requiring surgery. As an unphased trial, this study provides patients the chance to contribute to valuable research that could enhance surgical outcomes for Crohn's disease.

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications. You can participate regardless of whether you are untreated or taking steroids or biologics.

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

Research has shown that the Kono-S procedure is generally safe for people with Crohn’s disease. Studies indicate that this surgery has low rates of disease recurrence and fluid leakage at the surgical site. However, some patients experience moderate rates of disease returning at the surgery site when examined with a special camera.

In comparison, the side-to-side anastomosis (SSa) method also has available safety data. Evidence suggests it has a higher rate of disease recurrence at the surgery site than the Kono-S method. One study found a recurrence rate of 62.8% with SSa compared to 22.2% with Kono-S.

Both techniques are used in surgeries for Crohn’s disease, each with its own safety profile. People considering these procedures should discuss these findings with their healthcare provider to determine which option might be best based on their individual health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the surgical techniques being tested for Crohn's disease because they offer potentially improved outcomes for patients undergoing surgery. The Kono-S anastomosis (KSa) technique is unique because it aims to reduce the high rate of post-surgical complications, like recurrence of the disease, by creating a more stable and functional connection between bowel segments. This approach contrasts with the traditional side-to-side anastomosis (SSa), which is the current standard but may not be as effective in preventing disease recurrence. By exploring these different surgical methods, researchers hope to identify a technique that could lead to better long-term results and improve the quality of life for patients with Crohn's disease.

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

This trial will compare two surgical techniques for Crohn's disease: the Kono-S anastomosis (KSa) and the side-to-side anastomosis (SSa). Research has shown that the Kono-S anastomosis might lower the chances of Crohn's disease returning after surgery. Some studies found that patients who underwent this procedure showed fewer signs of recurrence during scope examinations. The Kono-S technique generally yields good short-term results and acceptable complication rates. However, other studies suggest that its effectiveness in reducing recurrence isn't always clear. In contrast, the side-to-side anastomosis is a more traditional method, commonly used and considered effective for Crohn's patients. This trial continues to study both procedures to better understand their effects on gut bacteria and the immune system. ^{2 6 7 8 9}

Who Is on the Research Team?

Fabrizio Michelassi, MD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for adults with Crohn's ileitis or ileocolitis who need surgery. It includes those previously in a related trial and all disease types (B1, B2, B3). Patients on any preoperative medication are eligible.

Inclusion Criteria

My preoperative medication status does not affect my eligibility.

You were previously part of the 'Kono-S anastomosis versus side-to-side functional end anastomosis in the prevention of post-operative recurrence of Crohn's Disease (WC IRB #1303013645)' trial.

I need surgery for my Crohn's affecting the ileum or ileum and colon.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Patients undergo surgical resection and are randomly assigned to either Kono-S or side-to-side anastomosis

1 day

1 visit (in-person)

Post-surgery Monitoring

Biopsies and genetic tests are conducted to analyze changes in the microbiome and immune environment

3-6 months, 12-18 months, and 60 months

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery

60 months

What Are the Treatments Tested in This Trial?

Interventions

• KSa
• SSa

Trial Overview

The study compares two surgical techniques for Crohn's Disease: Kono-S anastomosis (KSa) and side-to-side anastomosis (SSa), focusing on their effects on gut bacteria and the immune system within the intestines.

How Is the Trial Designed?

Group I: Kono-S anastomosis (KSa) Experimental Treatment 1 Intervention

Randomized enrollment of preoperative patients undergoing surgical resection for Crohn's ileitis or ileocolitis

Group II: side-to-side anastomosis (SSa) Active Control 1 Intervention

Randomized enrollment of preoperative patients undergoing surgical resection for Crohn's ileitis or ileocolitis

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Crohn's & Colitis Foundation of America, Inc.

Collaborator

Trials

1

Recruited

80+

Published Research Related to This Trial

In a study of 92 patients with degenerative spondylolisthesis who underwent surgery, 57.6% experienced no adverse events (AEs), while the most common intraoperative AEs were dural tears (6.5%) and bone-implant interface failures (3.3%).

Postoperative AEs were primarily infections, with urinary tract infections occurring in 10.9% of patients, and the risk of intraoperative AEs increased by 9% for each additional year of age, indicating that older patients may be at higher risk during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective analysis of adverse events in surgical treatment of degenerative spondylolisthesis. Kelly, AM., Batke, JN., Dea, N., et al.[2019]

Out of 409,991 patients who underwent soft tissue reconstructive procedures from 2005 to 2010, 4.06% experienced adverse events (AEs), indicating that while AEs are not uncommon, the overall rates are lower compared to other surgical disciplines.

Certain patient characteristics, such as older age, male gender, nonwhite ethnicity, and reliance on public insurance, were associated with higher rates of AEs, highlighting the need for targeted quality improvement efforts in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient safety in plastic surgery: identifying areas for quality improvement efforts. Hernandez-Boussard, T., McDonald, KM., Rhoads, KF., et al.[2022]

In a study of 346 patients undergoing spinal surgery, 20.8% experienced at least one perioperative adverse event (AE), with pediatric patients showing a higher severity of AEs compared to adults.

Common AEs included dural tears and neuropathic pain in adults, while pediatric patients most frequently experienced neurologic deterioration; these AEs were associated with longer hospital stays, averaging an additional 6 days.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative adverse events in adult and pediatric spine surgery: A prospective cohort analysis of 364 consecutive patients. Lovi, A., Gallazzi, E., Galbusera, F., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11263246/

Safety and effectivity of Kono-S anastomosis in Crohn's patients

Studies reporting outcomes of adults with Crohn's disease undergoing ileocolic resection with subsequent Kono-S anastomosis were included.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8208918/

Experiences with the Kono-S anastomosis in Crohn's ...

The Kono-S anastomosis is associated with acceptable short-term results, complications, and recurrence rates comparable with the established anastomotic ...

3.

academic.oup.com

academic.oup.com/ecco-jcc/article/19/Supplement_1/i32/7966906

OP16 Postoperative endoscopic recurrence after ileocecal ...

This study aims to compare the endoscopic recurrence between the Kono-S and side-to-side functional end anastomosis at 12-18 months after ileocecal resection ...

4.

link.springer.com

link.springer.com/article/10.1007/s10151-024-02991-7

Effect of Kono-S anastomosis on reducing postoperative ...

Kono-S anastomosis has gained increasing interest although evaluation of its impact on reducing Crohn's recurrence shows conflicting results.

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03256240

NCT03256240 | Study of the Kono-S Anastomosis Versus ...

Initial studies have demonstrated that the Kono-S anastomosis has prevented endoscopic evidence of the post-operative recurrence of Crohn's disease at greater ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39037448/

Safety and effectivity of Kono-S anastomosis in Crohn's ...

Patients undergoing Kono-S anastomosis had low rates of surgical recurrence and anastomotic leakage with moderate rates of endoscopic recurrence, clinical ...

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0002961023005780

Safety & feasibility of targeted mesenteric approaches with ...

Targeting the mesentery with novel surgical approaches to ileocolic Crohn's was found to be safe and feasible in terms of short-term outcomes.

8.

consultqd.clevelandclinic.org

consultqd.clevelandclinic.org/study-explores-impact-of-kono-s-anastomosis-on-crohns-disease-patients

Impact of Kono-S Anastomosis on Crohn's Disease Patients

Overall, 174 patients underwent ileocolic anastomosis. Of those, there were 83 patients (47.7%) in the Kono-S anastomosis group and 91 (52.3%) ...

9.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1111/ans.19181

Ileocolic resection for Crohn's disease and the Kono S ...

On the face of it, the findings of an endoscopic recurrence (i2 or greater) rate of 22.2% in the Kono S group vs. 62.8% in the stapled side to ...