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临床试验/NCT02532478
NCT02532478已完成不适用

Fortune of Temporary Ileostomies in Patients Treated With Laparoscopic Low Anterior Resection for Rectal Cancer

Dr. Lutfi Kirdar Kartal Training and Research Hospital0 个研究点目标入组 160 人开始时间: 2007年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
160
主要终点
Stoma closure rate

研究概览

简要总结

The risk factors for stoma reversal failure have been rarely studied, which is probably one of the worst scenarios for a case who has a sphincter preserving procedure for a rectal cancer and is expecting to have regular bowel movements through a functional anus. Several studies have analyzed this particular issue and some have shown that up to 30% of 'temporary' stomas have never been closed. However these data have been criticized to be heterogeneous, since they have included patients with benign and malignant diseases, cases underwent elective or emergent anterior or low anterior resections or restorative proctocolectomy; and those with a colostomy or ileostomy, even an end stoma in some subjects. In addition, some studies have underlined some risk factors for the failure of stoma reversal, but they also have similar limitations as mentioned above. Finally, survival -to the best of investigators' knowledge- has never been separately studied in patients who cannot receive a stoma reversal procedure. Thus, current study aims to present a single-surgeon experience regarding the rate of diverting ileostomy takedown, the factors adversely affecting stoma reversal rate in patients underwent laparoscopic low anterior resection for rectal cancer, and accordingly to expose the fortune of these cases.

详细描述

Defunctioning stomas are commonly formed in order to divert the bowel stream mostly in case of distal anastomosis, particularly after a low anterior resection. It has been reported that a temporary ileostomy may decrease the risk of an anastomotic leak, which is a lethal complication. In addition, in case of an anastomotic leak, stomas may limit the septic sequence and may help the diseased anastomosis to heal or the area of inflammation to resolve. Stomas have been also shown to decrease the necessity of an urgent reoperation due to septic intra-abdominal complications that may occur after an anastomotic leak. Many believe that stoma complications are generally easily managed and reversal of stomas are associated with limited morbidity. Thus, selective or routine creation of diverting stomas have been recommended in patients underwent a low anterior resection.

The risk factors for stoma reversal failure have been rarely studied, which is probably one of the worst scenarios for a case who has a sphincter preserving procedure for a rectal cancer and is expecting to have regular bowel movements through a functional anus. Several studies have analyzed this particular issue and some have shown that up to 30% of 'temporary' stomas have never been closed. However these data have been criticized to be heterogeneous, since they have included patients with benign and malignant diseases, cases underwent elective or emergent anterior or low anterior resections or restorative proctocolectomy; and those with a colostomy or ileostomy, even an end stoma in some subjects. In addition, some studies have underlined some risk factors for the failure of stoma reversal, but they also have similar limitations as mentioned above. Finally, survival -to the best of investigators' knowledge- has never been separately studied in patients who cannot receive a stoma reversal procedure. Thus, current study aims to present a single-surgeon experience regarding the rate of diverting ileostomy takedown, the factors adversely affecting stoma reversal rate in patients underwent laparoscopic low anterior resection for rectal cancer, and accordingly to expose the fortune of these cases.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • All patients who received laparoscopic low anterior resection and loop ileostomy for rectal cancer, except:

排除标准

  • patients undergoing an operation for a benign or recurrent disease or an emergent condition,
  • those presenting with insitu cancer or dysplasia without an invasive cancer,
  • those with cancers other than adenocarcinomas,
  • those received a restorative proctocolectomy,
  • those necessitated diversion for an irresectable tumor,
  • those received a diverting/end colostomy or end ileostomy,
  • Patients who had a recurrent disease and/or unresectable metastasis after the creation of stoma
  • those received a temporary stoma during the last 12 months

结局指标

主要结局

Stoma closure rate

时间窗: up to 84 months

次要结局

未报告次要终点

研究者

发起方
Dr. Lutfi Kirdar Kartal Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Nuri Okkabaz

MD

Dr. Lutfi Kirdar Kartal Training and Research Hospital

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