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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 30
- 主要终点
- Number of subjects with surgical recurrence at 120 months
研究概览
简要总结
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.
详细描述
Study Aim:
- The primary aim of this study is to compare the postoperative recurrence of CD using the modified 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 and 120 months between the groups. Evaluate histologic features in surgical specimen collected at the index surgery as predictors for endoscopic, clinical, and surgical recurrence after ileocecal resection for CD. To evaluate the histological mucosal healing at 60 months between the novel Kono-S anastomosis (Group1) and side-to-side functional end anastomosis (Group2) using Global Histology Activity Score and The Inflammatory Bowel Disease-Distribution, Chronicity, Activity [IBD-DCA] score.
- The secondary aim is to evaluate the postoperative endoscopic recurrence of CD using the modified Rutgeerts score at 12-18, 60 and 120 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 before surgery, and yearly after the surgery up 60 months the patient perception of illness measured by The Brief Illness Perception Questionnaire, (a 9-item questionnaire) score between the groups, to evaluate disease activity yearly using Harvey-Bradshaw Index, and monitor medication therapy, anastomotic strictures, readmission rates, and mortality rates through the 120 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, patient perspective on nutrition; and long-term psychosocial impact and nutrition challenges, and to evaluate the differences in the histological/mucosal healing between Kono-S and Side-to-Side anastomoses.
Methods
Design: This will be a multi-center randomized prospective trial with 500 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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
side-to-side functional end anastomosis
side-to-side functional end anastomosis creation
干预措施: side-to-side functional end anastomosis (Other)
Kono-S
antimesenteric functional side-to-side handsewn anastomosis, known as the Kono-S anastomosis
干预措施: Kono-S analstomosis (Other)
结局指标
主要结局
Number of subjects with surgical recurrence at 120 months
时间窗: 120 months after surgery
Number of anastomoses in need of surgical revision for Crohn's disease recurrence after the initial index surgery.
Number of subjects with surgical recurrence at 60 months
时间窗: 60 months after surgery
Number of anastomoses in need of surgical revision for Crohn's disease recurrence after the initial index surgery.
Post-operative remission of Crohn's disease between 3 and 6 months after surgery
时间窗: 3-6 months after surgery
Endoscopic remission with a Rutgeert score between 3 and 6 months in order to determine if the Kono-S procedure is more likely to prevent post-operative recurrence of Crohn's disease compared with the side-to-side functional end anastomosis. Endoscopic remission is defined as a Rutgeerts score of 0, 1, or 2a at 3-to-6 months post-procedure colonoscopy.
Post-operative endoscopic remission of Crohn's disease between 3 and 6 months after surgery
时间窗: 3-6 months after surgery
Endoscopic remission with a modified Rutgeerts score between 3 and 6 months in order to determine if the Kono-S procedure is more likely to prevent post-operative recurrence of Crohn's disease compared with the side-to-side functional end anastomosis. Endoscopic remission is defined as a modified Rutgeerts score of 0, 1, or 2a at 3-to-6 months post-procedure colonoscopy.
次要结局
- Health-Related Quality of Life using the Short Inflammatory Bowel Disease Questionnaire for Crohn's disease(10 questions)(up to 120 months)
- Work Productivity and Activity Impairment (WPAI) due to Crohn's disease(up to 120 months)
- Clinical disease activity measured by Harvey Bradshaw Index(up to 120 months)
- Post-operative remission of Crohn's disease between 12 and 18 months, at 60-, and 120 months after surgery(12-18, 60, and 120 months after surgery)
- Time to surgical recurrence between Group1 and Group2(up to 120 months)
- Medication therapy type(up to 120 months)
- Readmission rates between Group1 and Group2(up to 120 months)
- Mortality rate(up to 120 months)
- Surgical Pathology Margins(at surgery)
- Mucosal Healing(60 months after surgery)
- Mucosal Healing from colonoscopy biopsies(60 months after surgery)
- The Brief Illness Perception Questionnaire(up to 120 months)
- Focus Group(up to 120 months)