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临床试验/NCT03950726
NCT03950726已完成不适用

Minimally Invasive Open Technique for Ileo-colic Resection in Complex Cases of Terminal Ileum Crohn's Disease. Case Series.

University of Roma La Sapienza0 个研究点目标入组 27 人开始时间: 2016年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
27
主要终点
Mean operative time

研究概览

简要总结

Laparoscopic ileocolic resection is the preferred surgical approach for patients with ileocecal Crohn's disease (CD). Objective of this study was to evaluate the efficacy of a minimally invasive gas-less ileocolic resection in complex cases of CD through a Mc Burney incision, in patients who already had a previous appendectomy.

详细描述

From January 2016 to December 2017, all consecutive CD patients with primary or recurrent complex disease referred for IC resection were evaluated for the study purpose.Complex disease patients presenting McBurney incision for a previous open appendectomy were included in the group of study. This group was compared with a control group of CD patients with the same clinical characteristics of ileocolic disease who underwent standard laparoscopic IC resection, pooled out from the database of IC resections for CD of the Minimally Invasive and Gastrointestinal Surgery Unit of Tor Vergata Hospital, Rome, Italy. Data on demographics, BMI, type and behavior of CD, presence of disease apart from ileocecal site, previous surgery, recurrence, current medical treatment, thickening of the mesentery, preoperative imaging results (MR enterography or small intestine contrast ultrasound), operative time, blood loss, conversion to laparoscopy and conversion to open rates, complications, adherence rate to ERAS protocols and length of hospital stay were collected for the study purpose.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • diagnosed Crohn's disease
  • previous appendectomy trough a mcburney incision

排除标准

  • patients with major comorbidities
  • previous midline laparotomy

结局指标

主要结局

Mean operative time

时间窗: 75-156 minutes

duration of surgical procedure

Mean post-operative hospital stay

时间窗: 3-7 days

time from day of surgery to discharge

Mean blood loss during surgical procedure

时间窗: 2 hours

blood loss from the beginning to the end of the procedure

次要结局

  • post-operative complications(30 days)

研究者

发起方
University of Roma La Sapienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

simone sibio

associate professor

University of Roma La Sapienza

相似试验

Ileocolic Resection for Complex Crohn's Disease | 临床试验