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临床试验/NCT04578392
NCT04578392终止不适用

MeSenteric SpAring Versus High Ligation Ileocolic Resection for the Prevention of REcurrent Crohn's DiseaSe (SPARES)

The Cleveland Clinic11 个研究点 分布在 4 个国家目标入组 13 人开始时间: 2020年7月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
13
试验地点
11
主要终点
Endoscopic recurrence based on Rutgeert scoring at the time of colonoscopy

研究概览

简要总结

Study description - Patients will be randomized according to post-operative recurrence risk to either a high ligation of ileocolic artery or mesenteric sparing ileocolic resection for terminal ileal Crohn's disease. The primary endpoint 6-month endoscopic recurrence.

Endpoints - Primary endpoint; 6 months Secondary endpoints at 1 and 5 years post ileocecal resection

Study population - Adult Crohn's disease patients with medically refractory terminal ileal Crohn's disease undergoing a primary ileocecal resection.

Study sites - Multicenter international study

Description of study intervention - Randomized control trial of two operative techniques Operative approach of a high ligation of ileocolic artery as compared to mesenteric sparing for a primary ileocolic resection

Participate duration - 5 years

详细描述

There is increasing evidence to suggest that the mesentery may play an active role in the pathophysiology of Crohn's disease. There is significant clinical, endoscopic, and surgical recurrence of disease following ileocolic resection at the site of the anastomosis. The study is seeking to understand if the mesentery plays a role in recurrence following ileocolic resection.

Crohn's disease (CD) is a chronic inflammatory disease of the intestinal tract with an unknown etiology and an unknown cure. The characteristic transmural inflammation can progress to refractory inflammatory disease, stricturing disease, and fistulizing disease - all potential indications for surgery when medical management has been exhausted. An important tenant to remember is that surgery is not curative but is rather an adjunct to maximal medical therapy.

One third of patients with Crohn's disease (CD) will require a major abdominal resection within 5 years of their diagnosis, and two-thirds will ultimately require operative management at least once during the course of their disease.

Unfortunately, surgery for Crohn's disease (CD) is not curative and disease recurrence is common with 62% having endoscopic recurrence at six months, and 80% and 30% of patients having endoscopic and clinical recurrence, respectively, at one year. A third of these patients will require a reoperation at 10 years and up to 80% will require an additional operation by 15 years.This undoubtedly leads to an increased probability of malabsorption syndrome and decreased quality of life.

A significant volume of research has been conducted in attempt to determine how to prevent postoperative recurrence of CD following an ileocolic resection. Some studies have focused on the timing of resuming postoperative medical therapy. Others have looked at surgical technique at the time of ileocolic resection including anatomic configuration of the anastomosis and performing a stapled versus handsewn anastomosis. Various configurations include a side to side anastomosis, end to end, and Kono-S anastomosis. A randomized clinical trial compared a side to side versus an end to end, and found endoscopic recurrence rates were similar in the two groups (42.5% versus 37.9%) at a mean follow up of 11.9 months. A later multi-institution international trial of the Kono S anastomosis determined that the anastomosis was associated with a decreased surgical recurrence rate as compared to conventional anastomoses; 5 and 10 year surgical recurrence-free survival was 98.6%.15 Several Cochrane Database reviews have reported no difference in a stapled versus handsewn anastomosis for an ileocolic resection. Therefore, other than the potential decreased recurrence with the Kono-S anastomosis, no other surgical techniques have altered the postoperative recurrence rate of CD following an ileocolic resection.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Males and females 18-65 years of age.
  • Isolated ileocolic Crohn's disease of <30 cm in length
  • Concurrent therapies with corticosteroids, 5-ASA drugs, thiopurines, MTX, antibiotics, anti-TNF, vedolizumab, ustekinumab therapy are permitted.
  • Ability to comply with protocol
  • Competent and able to provide written informed consent
  • Medically refractory disease or inability to tolerate ongoing medical therapy

排除标准

  • Inability to give informed consent.
  • Patients less than 18 years of age
  • Patients undergoing repeat ileocolic resection
  • Patients with concurrent disease in other locations (e.g. proximal stricturing of the small bowel, fistulizing disease to the sigmoid colon) requiring an additional intervention in the operating room beyond an ileocolic resection.
  • Patients with >30 cm of terminal ileal disease
  • Patients who are undergoing an ileal resection only (NOT ileocecal) because the disease spares the distal most aspect of ileum and ileocecal valve
  • Patient whose anastomosis is diverted intra-operatively with a loop or end ileostomy
  • Clinically significant medical conditions within the six months before surgery: e.g. myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the patient.
  • Specific exclusions; Evidence of hepatitis B, C, or HIV
  • History of cancer including melanoma (with the exception of localized skin cancers)
  • Emergent indication for an operation
  • Pregnant or breast feeding.
  • History of clinically significant auto-immunity (other than Crohn's disease) or any previous example of fat-directed autoimmunity
  • Inability to follow up at respective sites for the primary endpoint

研究组 & 干预措施

high ligation of ileocolic artery

Active Comparator

Randomized control trial of two operative techniques Operative approach of a high ligation of ileocolic artery as compared to mesenteric sparing for a primary ileocolic resection

干预措施: high ligation of ileocolic artery (Procedure)

high ligation of ileocolic artery

Active Comparator

Randomized control trial of two operative techniques Operative approach of a high ligation of ileocolic artery as compared to mesenteric sparing for a primary ileocolic resection

干预措施: mesenteric sparing (Procedure)

mesenteric sparing for a primary ileocolic resection

Active Comparator

Randomized control trial of two operative techniques Operative approach of a high ligation of ileocolic artery as compared to mesenteric sparing for a primary ileocolic resection

干预措施: high ligation of ileocolic artery (Procedure)

mesenteric sparing for a primary ileocolic resection

Active Comparator

Randomized control trial of two operative techniques Operative approach of a high ligation of ileocolic artery as compared to mesenteric sparing for a primary ileocolic resection

干预措施: mesenteric sparing (Procedure)

结局指标

主要结局

Endoscopic recurrence based on Rutgeert scoring at the time of colonoscopy

时间窗: 6 months

Endoscopic recurrence is define as a Rutgeert score \>2 at the time of colonoscopy The score is attributed directly, by selecting the appropriate degree - 5 degrees, from i0 (lowest) to i4 highest, with single-choice selection menu. Rutgeerts score is only be used for evaluation of post-surgical recurrences at ileocolic anastomosis level.

次要结局

  • Endoscopic Recurrence - Rutgeert score(1 year)
  • Surgical Recurrence(1 and 5 years)
  • Clinical Recurrence - Crohn's Disease Activity Index (CDAI)(6 months, 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anthony Lembo

Associate Professor of Surgery in the Department of Colon and Rectal Surgery at Cleveland Clinic

The Cleveland Clinic

研究点 (11)

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