Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 90 Years|
Inclusion Criteria:1. Patients with Crohn's ileitis or ileocolitis age 18 or older requiring surgical resection. nonpenetrating (B1), stricturing (B2), and penetrating (fistulating) (B3), according to the Vienna classification) 2. 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 pregnant patients and 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. 3. Subjects who do not speak English
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Weill Medical College of Cornell University|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Fabrizio Michelassi, MD|
|Principal Investigator Affiliation||Weill Medical College of Cornell University|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Belgium, Germany, Italy, United States|
The disease, disorder, syndrome, illness, or injury that is being studied.
Aim of the study: To compare the post-operative recurrence of Crohn's disease using Rutgeert score at three months between Kono-S procedure and the side-to-side functional end anastomosis. Methods Design: This will be a multi-center randomized prospective trial. Patients with Crohn's ileitis or Crohn's ileocolitis requiring initial resection will be randomized to undergo either the Kono-S anastomosis or the side-to-side functional end anastomosis. Patients will be randomized into two Groups: Group 1: Kono-S anastomosis vs.#46; Group 2: side-to-side functional end anastomosis. The purpose of this study is to compare the post-operative recurrence of Crohn's disease between Kono-S procedure and the side-to-side functional end anastomosis. In any intestine surgery, after the sick portion of the bowel is removed, the intestinal tract is restored by reconnecting the healthy ends together. The new connecting line is called anastomosis, and could be created in a variety ways by the surgeon. This study will compare two different intestinal connections called Kono-S anastomosis and the traditional side-to-side functional end anastomosis. Initial studies have demonstrated that the Kono-S anastomosis has prevented endoscopic evidence of the post-operative recurrence of Crohn's disease at greater rates than the traditional side-to-side functional end anastomosis. There is no evidence which of these commonly-used treatments is better because more information is needed. The purpose of this study is to find this by doing this study. Follow up: Patients will be discharged on no prophylactic treatments and they will be followed post- operatively at 3to 6 and 12 months with a colonoscopy to assess for endoscopic recurrence. The mucosa will be graded with the Rutgeerts score for post-operative recurrence. All colonoscopies are part of the standard treatment. All patients will have also standard 30 days follow up. Follow up Care: Patients with a Rutgeerts score at 3 months of:
- - 0, 1 or 2a will be followed prospectively without introducing medical treatment.
- - above >2a will initiate medical therapy for Crohn's disease - should the patient's symptoms warrant colonoscopic evaluation earlier than three months; this will be done at the gastroenterologist's discretion.
Active Comparator: side-to-side functional end anastomosis
side-to-side functional end anastomosis creation
Active Comparator: Kono-S
antimesenteric functional side-to-side handsewn anastomosis, known as the Kono-S anastomosis
Other: - side-to-side functional end anastomosis
type of anastomosis
Other: - Kono-S analstomosis
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