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Compensation: Varies

Number of Visits: 4

80 Participants Needed

Surgical Techniques for Crohn's Disease

Overseen ByKoianka 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 GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.

Is the surgical technique for Crohn's Disease safe for humans?

Bariatric surgery, which is sometimes used in patients with inflammatory bowel disease (IBD) like Crohn's, has been found to be relatively safe. In a study of 2608 patients, the rates of serious complications were low, with wound infections at 4.1%, serious complications at 2.0%, and IBD flare-ups at 4.3%.¹ ² ³ ⁴ ⁵

How does the treatment KSa, SSa for Crohn's disease differ from other treatments?

The treatment KSa, SSa for Crohn's disease is unique because it involves specific surgical techniques that focus on bowel preservation, such as strictureplasty, which helps relieve obstructive symptoms while maintaining intestinal length. Additionally, minimally invasive options like laparoscopic and robotic-assisted techniques are emphasized, offering benefits like shorter hospital stays and faster recovery compared to traditional open surgery.⁶ ⁷ ⁸ ⁹ ¹⁰

What is the purpose of this trial?

The purpose of this study is to compare the effect of two procedures - the Kono-S procedure and the side-to-side functional end to end anastomosis - on the microbiome (the bacteria that live in our gut) and on the intestinal immune system. The investigators are hypothesizing that there are differences in the microbiome environment and the immune environment between the two procedural groups.

Research Team

Fabrizio Michelassi, MD

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

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.

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Timeline

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

Treatment Details

Interventions

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.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Kono-S anastomosis (KSa)Experimental Treatment1 Intervention

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

Group II: side-to-side anastomosis (SSa)Active Control1 Intervention

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

Find a Clinic Near You

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

Recruited

80+

Findings from Research

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 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]

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]