RightFit
RecruitingNot applicable

Study of the Kono-S Anastomosis Versus the Side-to-side Functional End Anastomosis

Prospective Randomized Study of the Kono-S Anastomosis Versus the Side-to-side Functional End Anastomosis in the Prevention of Post-operative Recurrence of Crohn's Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 90 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Phone or video check-ins

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "All patients will have also standard 30 days, 3 to 6, 12 to 18, 24, 36-, 48-, 60-, 72-, 84-, 96-, 108-, and 120 months follow-ups by phone call, through medical records, or during the postoperative clinic visit."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares two ways to join the bowel after removing a diseased part: Kono-S and the standard side-to-side method. It is for adults with Crohn’s disease in the small bowel, or in both the small bowel and colon, who need their first surgery to remove diseased bowel. Patients are assigned to a method by chance.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have Crohn’s disease in the small bowel, or in both the small bowel and colon, and need a first surgery to remove diseased bowel.
  • Be age 18 or older. Men and women can join.
  • All listed types of Crohn’s disease are allowed, including disease that narrows the bowel or forms abnormal tunnels called fistulas.
  • You may be taking any medicines before surgery, including past anti-TNF treatment, which blocks a substance that causes inflammation.

Who can't join

  • Be younger than 18.
  • Have Crohn’s disease that has come back.
  • Be pregnant.
  • Have active disease in separate bowel areas that need more than one removal or extra bowel-saving procedures during surgery.
  • Have Crohn’s disease that extends into the first parts of the colon, called the cecum and ascending colon.
  • Need medicine after surgery to prevent the disease from coming back.
  • Need a different surgical procedure based on what the surgeon finds during surgery.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Patients with Crohn's ileitis or ileocolitis requiring initial surgical resection. 2. Age of 18 years and older, male and female 3. All Phenotypes of Crohn's diisease will be included: nonpenetrating (B1), stricturing (B2), and penetrating (fistulating) (B3), according to the Vienna classification 4. The patients can be on any medications coming into surgery, including prior anti- tumor necrosis factor(TNF) therapy. Exclusion Criteria: 1. Patients under 18 years of age 2. Patients with recurrent Crohn's 3. Pregnant patients 4. Patients with more than one non-contiguous site of active disease, thus requiring multiple resections or additional bowel sparing procedures at the time of surgery. 5. Patients with Crohn's disease extending to the cecum and ascending colon 6. Patients who will need preventive postoperative medical treatment 7. Patients that need change of surgical procedure as per the surgeon at the time of the intraoperative abdominal evaluation.

Study sites (6)

MA

NY

OK

TX

WA