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临床试验/NCT03045107
NCT03045107Unknown不适用

Intracorporeal or Extracorporeal Ileocolic Anastomosis After Laparoscopic Right Colectomy.

University of Turin, Italy2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2017年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
140
试验地点
2
主要终点
Length of hospital stay

研究概览

简要总结

During the last few years, the laparoscopic right colectomy with intracorporeal ileocolic anastomosis (IIA) has been proposed as an alternative to laparoscopic right colectomy with extracorporeal ileocolic anastomosis (EIA) for the treatment of right colon tumors. However, the level of evidence coming from the currently available literature is low, based on the results of a few small and heterogeneous retrospective non-randomized studies. A randomised controlled trial is warranted to challenge these two procedures. The aim of this randomized controlled trial is to assess the outcomes after IIA or EIA after laparoscopic right colectomy for right colon tumors.

详细描述

While there are no differences in oncologic principles (no touch technique, proximal vessel ligation, lymphadenectomy) between laparoscopic right colectomy with IIA and EIA, potential advantages of IIA are: (1) no need for extensive mobilization of the transverse colon to reach the abdominal wall; (2) performing the anastomosis away from the abdominal wall may lead to reduced rates of superficial site infection; (3) a shorter incision for the specimen extraction may be associated with clinical benefits such as less pain and lower rates of superficial site infections; (4) laparoscopic visualization during the creation of the IIA may reduce unrecognized twisting of the terminal ileum mesentery, and (5) the ability to remove the specimen through any type of incision, with subsequent reduced risks of incisional hernias in case of Pfannenstiel incision when compared to midline or off-midline incisions.

Some retrospective and heterogeneous studies comparing perioperative outcomes after laparoscopic right colectomy with EIA and IIA have been published in the last decade, reporting controversial results. Furthermore, the results of recent metanalyses are challenged by the heterogeneity and the poor quality of the published studies. Lastly, no comprehensive economic evaluation of the two procedures have been performed yet.

Consecutive patients with right colon tumors are included in a randomized controlled trial. This is a single Institution prospective randomized controlled trial comparing the outcomes in patients undergoing laparoscopic right colectomy with IIA or EIA for right colon neoplasm. Eligible patients will be randomly assigned in a 1:1 ratio to undergo either laparoscopic IA or EA according to a list of randomization numbers with treatment assignments. This list will be computer generated. An Internet application will allow central randomization.

Cost analysis will be based on the following costs: surgical instruments (including re-usable trocars and disposable tools), operative room, routine postoperative surgical care, diagnosis and treatment of postoperative complications. Operative room costs include healthcare personnel, medications, and structure costs. To calculate the cost of each postoperative complication, the following items will be assessed: laboratory and microbiology analysis; medical, technical, and diagnostic services; surgical and therapeutic interventions; medications; prolonged hospital stay, and outpatient clinic follow-up. The mean length of hospital stay of uncomplicated patients will be the basis to calculate the prolonged hospital stay in each patient with complication. In patients who will develop multiple complications, resources used to treat each complication will be recorded separately.

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
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

A big dressing covering all incisions will be applied at the end of each operation in both arms.

入排标准

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

入选标准

  • Patient diagnosed with a solitary benign or malignant neoplasm localized in the right colon
  • Patients aged 18 years or older
  • Patients who give written informed consent

排除标准

  • acute intestinal obstruction
  • colon perforation;
  • liver and/or lung metastases;
  • multiple primary colonic tumors;
  • scheduled need for synchronous intra-abdominal surgery;
  • preoperative evidence of invasion of adjacent structures, as assessed by CT or ultrasonography;
  • previous ipsilateral colon surgery.

结局指标

主要结局

Length of hospital stay

时间窗: 1 month

次要结局

  • Length of incisions(At the end of the operation)
  • Intraoperative complications(intraoperatively)
  • Number of lymph nodes harvested(3 weeks)
  • 30-day postoperative morbidity according to the Clavien-Dindo classification(1 month)
  • First gas and stool passage(1 week)
  • Evaluation of postoperative pain (VAS)(1 week)
  • Duration of intravenous analgesic therapy(1 week)
  • Narcotics use rate(from day 1 to day 5 after surgery)
  • Reoperation rate(1 week)
  • Hospital readmission(90 days)
  • In-hospital costs(60 days)
  • Rate of incisional hernias(postoperatively at 3 and 6 months)
  • Quality of life(preoperatively, at 3 and 6 months after surgery)

研究者

发起方
University of Turin, Italy
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Mario Morino

Professor

University of Turin, Italy

研究点 (2)

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