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Compares treatment options for Crohn's Disease
Official title Study of the Kono-S Anastomosis Versus the Side-to-side Functional End Anastomosis
ClinicalTrials.gov ID: NCT03256240
What this study is testing
- What it's testing
- 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.
- Time commitment: about 120 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- Patients with Crohn's ileitis or ileocolitis requiring initial surgical resection.
- Age of 18 years and older, male and female
- All Phenotypes of Crohn's diisease will be included: nonpenetrating (B1), stricturing (B2), and penetrating (fistulating) (B3), according to the...
- The patients can be on any medications coming into surgery, including prior anti- tumor necrosis factor(TNF) therapy.
You likely can't join if
- Patients under 18 years of age
- Patients with recurrent Crohn's
- Pregnant patients
- Patients with more than one non-contiguous site of active disease, thus requiring multiple resections or additional bowel sparing procedures at the...
- Patients with Crohn's disease extending to the cecum and ascending colon
- Patients who will need preventive postoperative medical treatment
See the full eligibility criteria
- Patients with Crohn's ileitis or ileocolitis requiring initial surgical resection.
- Age of 18 years and older, male and female
- All Phenotypes of Crohn's diisease will be included: nonpenetrating (B1), stricturing (B2), and penetrating (fistulating) (B3), according to the Vienna classification
- The patients can be on any medications coming into surgery, including prior anti- tumor necrosis factor(TNF) therapy.
- Patients under 18 years of age
- Patients with recurrent Crohn's
- Pregnant patients
- 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.
- Patients with Crohn's disease extending to the cecum and ascending colon
- Patients who will need preventive postoperative medical treatment
- Patients that need change of surgical procedure as per the surgeon at the time of the intraoperative abdominal evaluation.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- New York, New York, United States
- Oklahoma City, Oklahoma, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Seattle, Washington, United States
- Leuven, Belgium
- Helsinki, Helsinki, Finland
- Würzburg, Wurzburg, Germany
- Berlin, Germany
- Mannheim, Germany
- Florence, Florence, Italy
- Rozzano, Milan, Italy
- Naples, Italy
- Barcelona, Barcelona, Spain
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 120 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; New York, New York, United States; Oklahoma City, Oklahoma, United States; Dallas, Texas, United States; Houston, Texas, United States; Seattle, Washington, United States and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.