Study Aim:~The primary aim of this study is to compare the postoperative recurrence of CD using the Rutgeerts score at 3-6 months between the novel Kono-S anastomosis (Group1) and side-to-side functional end anastomosis (Group2) and surgical recurrence rate at 60 months between the groups.~The secondary aim is to evaluate the postoperative recurrence of CD using the Rutgeerts score at 12-18 and 60 months between the groups; time to surgical recurrence between Group1 and Group2 measured in months from the index surgery, yearly Crohn's disease surgical therapy impact using the Work Productivity and Activity Impairment (WPAI) questionnaire; yearly Health-Related Quality of Life using the Short Inflammatory Bowel Disease Questionnaire, to evaluate disease activity yearly using Harvey-Bradshaw Index and monitor medication therapy, readmission rates, and mortality rates through the 60 months follow-up, and utilize Focus Groups from national and international study sites to evaluate patient's perspectives on surgical treatment, patients' goals of surgical treatment, and surgical treatment's personal and social impacts~Methods~Design: This will be a multi-center randomized prospective trial with 338 subjects. 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. Group 2: side-to-side functional end anastomosis.~The purpose of this study is to compare the postoperative recurrence of Crohn's disease between the Kono-S procedure and the side-to-side functional end anastomosis and to evaluate the surgical recurrence rate at 60 months between the groups.~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 of 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.~Follow-up: Patients will be discharged on no prophylactic treatments, and they will be followed post-operatively at 3 to 6, 12 to 18, and 60 months with a colonoscopy to assess for endoscopic recurrence. The mucosa will be graded with the Rutgeerts score for postoperative recurrence. All colonoscopies are part of the standard treatment. All patients will have also standard 30 days, 3 to 6, 12 to 18, 24, 36, 48, and 60 months follow-ups by phone call, through medical records, or during the postoperative clinic visit.~Follow-up Care: Patients with a Rutgeerts score at 3-to-6 months of:~0, 1, or 2a will be followed prospectively with or without introducing medical treatment at the discretion of the gastroenterologist.~above >2a will initiate medical therapy for Crohn's disease~Should the patient's symptoms warrant, medical treatment can be initiated at any time at the discretion of the gastroenterologist. This is a standard of care~Colonoscopic images (still color photos acceptable) will be shown to a gastroenterologist blinded to the goal of the study for determination of the Rutgeerts score.~post-operative endoscopic recurrence of CD using the Rutgeerts score at 12-18 months and 60 months between the groups. An endoscopic Rutgeerts score of 2b or higher will be considered a recurrence.~Time to surgical recurrence between Group1 and Group2 measured in months from the index surgery~Work Productivity and Activity Impairment (WPAI) questionnaire (a 6-item questionnaire that measures the amount of absenteeism and presenteeism due to health problems) will be administered annually for up to 60 months~Health-Related Quality of Life using the Short Inflammatory Bowel Disease Questionnaire (SIBDQ) (a 10-item shortened version of the original IBDQ, measuring the quality of life in four domains: bowel symptoms, emotional health, systemic systems, and social function) will be administered annually for up to 60 months.~Harvey Bradshaw Index as a marker of clinical disease activity will be used. This will be recorded before the procedure (baseline), at 3 to 6 and 12-18 months, 24, 36, 48, and at 60 months post-procedure.~Other monitoring- monitor medication therapy, readmission rates, and mortality rates annually through the 60 months of follow-up between the groups~Focus groups from national and international study sites to evaluate patients' perspectives on surgical treatment, patients' goals of surgical treatment, and surgical treatment's personal and social impacts. This is a qualitative evaluation.
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.