Kono-S vs Side-to-Side Anastomosis for Crohn's Disease

Recruiting at 7 trial locations

Overseen By Koianka Trencheva, Dr.PH,BSN,MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Recurrent Crohn's, Pregnancy, others

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

Compensation: Varies

Number of Visits: 16

550 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two surgical methods for treating Crohn's disease affecting the intestines: the Kono-S anastomosis and the standard side-to-side anastomosis. The researchers seek to determine which method is more effective for patients needing surgery due to Crohn's ileitis or ileocolitis (inflammation of the small intestine or both the small and large intestines). Participants should have Crohn's disease requiring their first intestinal surgery and can be on any medication, including past treatments with anti-TNF therapy (a common medication for Crohn's).

As an unphased trial, this study provides patients the opportunity to contribute to important research that could improve surgical outcomes for Crohn's disease.

Will I have to stop taking my current medications?

The trial does not specify that you need to stop taking your current medications before surgery. You can be on any medications, including prior anti-TNF therapy, when entering the study.

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

Research has shown that the Kono-S anastomosis is a safe surgical method. Patients who underwent this procedure generally experienced few surgical complications, such as leaks, and rarely required another surgery soon after. However, some patients did have moderate rates of endoscopic recurrence, meaning some signs of the disease returned when checked with a camera.

For the side-to-side functional end anastomosis, studies have compared it to other methods and found it reliable as well. One study suggested that this technique might have a lower chance of the disease returning compared to other methods.

Both techniques are generally well-tolerated, with research supporting their safety for patients with Crohn's disease. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Kono-S anastomosis technique for Crohn's disease because it offers a new approach to intestinal surgery. Unlike the traditional side-to-side functional end anastomosis, the Kono-S method is a handsewn, antimesenteric functional side-to-side anastomosis. This design aims to reduce surgical complications and improve long-term outcomes by strengthening the intestinal connection and minimizing recurrence at the surgical site. By potentially offering a more durable and less complication-prone option, the Kono-S technique could improve the quality of life for those living with Crohn's disease.

What evidence suggests that this trial's anastomosis techniques could be effective for Crohn's disease?

This trial will compare the Kono-S anastomosis with the side-to-side functional end anastomosis for Crohn's disease. Studies have shown that the Kono-S surgery effectively reduces the recurrence of Crohn's disease after an operation, with patients often experiencing fewer instances of the disease returning at the surgery site. Research indicates that the Kono-S method is safe and can help avoid more surgeries in the future. Meanwhile, the side-to-side surgery is also a reliable method and can reduce the risk of complications after surgery. Both techniques aim to improve outcomes for Crohn's disease patients by decreasing the need for additional surgeries. ^{1 2 4 6 7}

Who Is on the Research Team?

Koianka Trencheva, Dr.PH,BSN,MS

Principal Investigator

Weill Medical College of Cornell University

Fabrizio Michelassi, MD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

Adults with any type of Crohn's disease needing initial surgery for ileitis or ileocolitis can join. They must be over 18 and can have had any treatment, including anti-TNF therapy. Not eligible if under 18, pregnant, have recurrent Crohn's, multiple active sites requiring more surgeries, disease extending to the cecum/ascending colon, or need a different surgery during operation.

Inclusion Criteria

I am currently taking medication, including treatments for inflammation.

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

My Crohn's disease fits into one of the categories: nonpenetrating, stricturing, or penetrating.

Exclusion Criteria

My Crohn's disease affects my cecum and ascending colon.

I will need medicine after surgery to prevent complications.

My surgeon may change my surgery plan after looking inside my abdomen.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Patients undergo either the Kono-S anastomosis or the side-to-side functional end anastomosis

1 week

1 visit (in-person)

Initial Follow-up

Post-operative follow-up to assess endoscopic recurrence using the Rutgeerts score

3-6 months

Colonoscopy at 3-6 months

Extended Follow-up

Long-term follow-up to monitor surgical recurrence and quality of life

120 months

Annual assessments and colonoscopies at 12-18, 60, and 120 months

What Are the Treatments Tested in This Trial?

Interventions

• Kono-S analstomosis
• side-to-side functional end anastomosis

Trial Overview This study compares two surgical techniques in patients with Crohn's: Kono-S anastomosis versus side-to-side functional end anastomosis. It is randomized and prospective across multiple centers to see which method is better after resection in those with ileitis or ileocolitis.

How Is the Trial Designed?

Group I: Kono-S Active Control 1 Intervention

antimesenteric functional side-to-side handsewn anastomosis, known as the Kono-S anastomosis

Group II: side-to-side functional end anastomosis Active Control 1 Intervention

side-to-side functional end anastomosis creation

Kono-S analstomosis is already approved in Japan, United States, European Union for the following indications:

Approved in Japan as Kono-S Anastomosis for:

• Crohn's disease

Approved in United States as Kono-S Anastomosis for:

• Crohn's ileitis
• Crohn's ileocolitis

Approved in European Union as Kono-S Anastomosis for:

• Crohn's disease

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Crohn's and Colitis Foundation

Collaborator

Trials

44

Recruited

27,500+

Published Research Related to This Trial

In a study of 187 patients who underwent the Kono-S anastomosis for Crohn's disease, the technique demonstrated a very low rate of surgical recurrence, with only two recurrences in the Japanese group over a median follow-up of 65 months, resulting in a 5 and 10-year surgical recurrence-free survival rate of 98.6%.

The Kono-S anastomosis was found to be technically feasible and safe, with no surgical anastomotic recurrences reported in the US group during a median follow-up of 32 months, indicating its effectiveness in preventing surgical complications associated with Crohn's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kono-S Anastomosis for Surgical Prophylaxis of Anastomotic Recurrence in Crohn's Disease: an International Multicenter Study. Kono, T., Fichera, A., Maeda, K., et al.[2018]

A randomized controlled trial showed that the Kono-S hand-sewn end-to-end anastomosis significantly reduces postoperative recurrence rates in Crohn's disease compared to stapled ileocolic side-to-side anastomosis.

This paper introduces a totally stapled version of the Kono-S anastomosis, which may offer the same benefits as the hand-sewn technique while potentially being easier to perform in surgical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Totally stapled Kono-S anastomosis for Crohn's disease. Bislenghi, G., Devriendt, S., Wolthuis, A., et al.[2022]

The Kono-S anastomosis, used in surgery for Crohn's disease, showed a very low surgical recurrence rate of 0% and a reduced mean Rutgeerts score of 1.375, indicating effective long-term outcomes for patients.

Complications from the Kono-S anastomosis were rare, with only 3% experiencing ileus and 1% having an anastomotic leak, suggesting it is a safe surgical option for ileocolic anastomosis in Crohn's disease patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kono-S anastomosis for Crohn's disease: a systemic review, meta-analysis, and meta-regression. Ng, CH., Chin, YH., Lin, SY., et al.[2021]

The Kono-S anastomosis technique, first performed in Japan in 2003, has significantly reduced the rates of surgical recurrence in patients with Crohn's disease, showing promising long-term outcomes with very few patients experiencing recurrence.

This method is superior to traditional stapled anastomosis as it creates a stabilizing structure that helps maintain the integrity of the anastomosis, potentially making it the new standard of care for intestinal Crohn's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical Treatment for Crohn's Disease: A Role of Kono-S Anastomosis in the West. Kono, T., Fichera, A.[2021]

The Kono-S anastomosis technique for ileocecal resection in Crohn's disease shows acceptable short-term outcomes, with postoperative complications occurring in only 10% of patients, which is comparable to traditional methods.

While the Kono-S technique resulted in longer surgery times, it has promising long-term recurrence rates, suggesting it may be a viable option for reducing anastomotic recurrence in Crohn's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experiences with the Kono-S anastomosis in Crohn's disease of the terminal ileum-a cohort study. Horisberger, K., Birrer, DL., Rickenbacher, A., et al.[2021]

The stapled antimesenteric functional end-to-end anastomosis technique was performed on 17 patients with Crohn's disease, showing a low incidence of endoscopic recurrence at 11.8% and no postoperative mortality or anastomotic leakage, indicating its safety.

With an average operative time of 106 minutes and a specific construction time of 21 minutes, this method may offer a more efficient alternative to traditional handsewn techniques while maintaining effectiveness in preventing anastomotic recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stapled Antimesenteric Functional End-to-End Anastomosis Following Intestinal Resection for Crohn's Disease. Duan, M., Wu, E., Xi, Y., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/22580840/

Antimesenteric functional end-to-end handsewn (Kono-S) ... Currently, 18 patients (43 %) have undergone follow-up endoscopic surveillance with an average Rutgeert's score of 0.7 (0-3) at a mean of 6.8 months.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1072751515013526

A new antimesenteric functional end-to-end handsewn ... KSA is a safe surgical technique with low anastomotic endoscopic recurrence and short-term efficacy in preventing surgical recurrence in CD patients.

3. link.springer.com link.springer.com/article/10.1007/s00423-024-03412-x

Safety and effectivity of Kono-S anastomosis in Crohn's ... This indicates that the Kono-S anastomosis may have a protective role in endoscopic recurrence and CD progression at the anastomotic site.

4. journals.lww.com journals.lww.com/dcrjournal/fulltext/2024/11000/kono_s_anastomosis_technique_for_recurrent_crohn_s.20.aspx

Kono-S Anastomosis Technique for Recurrent Crohn's ... The Kono-S anastomosis technique is an effective and feasible alternative for treating recurrent Crohn's disease with low recurrence rates.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7605911/

Surgical Treatment for Crohn's Disease: A Role of Kono-S ... This excellent result suggests that Kono-S anastomosis appears to be safe and effective in reducing the risk of surgical recurrence in patients with CD.

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/S1091255X23039707

Antimesenteric Functional End-to-End Handsewn (Kono-S) ... Conclusion. The Kono-S anastomosis is a safe anastomotic technique. Long-term studies are needed to confirm its efficacy in preventing surgical recurrence.