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

Trial Summary

What is the purpose of this trial?

This study proposes a randomized prospective study comparing the Kono-S anastomosis to the standard side-to-side anastomosis.This will be a multi-center randomized prospective trial. Patients with Crohn's ileitis or Crohn's ileocolitis requiring resection will be randomized to undergo either the Kono-S anastomosis or the side-to-side functional end anastomosis.

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 data supports the effectiveness of the Kono-S anastomosis treatment for Crohn's Disease?

Research shows that the Kono-S anastomosis treatment significantly reduces the risk of surgical recurrence in Crohn's Disease patients compared to other methods, with very few patients experiencing recurrence after surgery. It has been shown to be more effective than the stapled side-to-side anastomosis, making it a promising option for preventing complications after surgery. ^{1 2 3 4 5}

Is the Kono-S anastomosis generally safe for humans?

The Kono-S anastomosis, used in surgeries for Crohn's disease, has shown a low risk of complications. Studies report rare occurrences of issues like bowel obstruction (4%), infection (10%), and anastomotic leaks (1%), indicating it is generally safe for humans. ^{1 2 3 4 5}

How does the Kono-S treatment for Crohn's disease differ from other treatments?

The Kono-S treatment is unique because it is a surgical technique designed to reduce the risk of recurrence after surgery for Crohn's disease. Unlike other methods, it involves creating a stabilizing structure to prevent distortion of the surgical site, which helps reduce the chance of the disease coming back. ^{1 2 3 4 6}

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

Eligibility Criteria

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.

I am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Kono-S Anastomosis for Surgical Prophylaxis of Anastomotic Recurrence in Crohn's Disease: an International Multicenter Study. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Surgical Treatment for Crohn's Disease: A Role of Kono-S Anastomosis in the West. [2021]

3. Italy pubmed.ncbi.nlm.nih.gov

Totally stapled Kono-S anastomosis for Crohn's disease. [2022]

4. Japan pubmed.ncbi.nlm.nih.gov

Kono-S anastomosis for Crohn's disease: a systemic review, meta-analysis, and meta-regression. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Stapled Antimesenteric Functional End-to-End Anastomosis Following Intestinal Resection for Crohn's Disease. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Experiences with the Kono-S anastomosis in Crohn's disease of the terminal ileum-a cohort study. [2021]