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临床试验/CTRI/2018/01/011064
CTRI/2018/01/011064已完成不适用

Ileocolic Anastomotic Leaks - An Institutional Study

Kasturba Medical College Manipal1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2016年12月14日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
140
试验地点
1
主要终点
The objective is to investigate any association between the variables considered and the occurrence of Anastomotic Leak.

研究概览

简要总结

Anastomotic leak is the most feared complication following intestinal resection with incidence varying between 1.8%1 and 15.9%. Anastomotic leakage is associated with the need for re-operation, prolonged hospital stay and increased morbidity and mortality. Controversy surrounds the list of risk factors associated with Anastomotic Leaks with preoperative Serum Protein concentration being found to be an independent risk factor. The influence of surgeon factors over the occurrence of anastomotic leaks has found little evidence. Multiple reoperations and stoma creation are often necessary to control the leak, which significantly increases health risks and health care costs. Hence knowledge about risk factors predisposing patients to Anastomotic Leak will be helpful in early detection and management of an otherwise fatal complication.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Colectomy (radical/limited) with Ileocolic Anastomosis End ileostomy reversal with Ileocolic Anastomosis.

排除标准

  • Patients who underwent Ileocolic Anastomosis elsewhere and were referred to Kasturba Hospital with Anastomotic Leak Patients with Ileocolic Anastomosis with Diversion Loop Ileostomy Patients with Ileorectal Anastomosis Patients with Ileal pouch Anal Anastomosis Age below 18 years.

结局指标

主要结局

The objective is to investigate any association between the variables considered and the occurrence of Anastomotic Leak.

时间窗: The occurrence of leak within 30 days of the surgery

Age

时间窗: The occurrence of leak within 30 days of the surgery

Preoperative Albumin

时间窗: The occurrence of leak within 30 days of the surgery

Coexisting illness

时间窗: The occurrence of leak within 30 days of the surgery

Indication for surgery

时间窗: The occurrence of leak within 30 days of the surgery

Experience of the surgeon

时间窗: The occurrence of leak within 30 days of the surgery

Duration of surgery

时间窗: The occurrence of leak within 30 days of the surgery

Mode of diagnosis of leak

时间窗: The occurrence of leak within 30 days of the surgery

Nature of surgery

时间窗: The occurrence of leak within 30 days of the surgery

Preoperative bowel preparation

时间窗: The occurrence of leak within 30 days of the surgery

Technique of anastomosis

时间窗: The occurrence of leak within 30 days of the surgery

Management of leak

时间窗: The occurrence of leak within 30 days of the surgery

Type of anastomosis

时间窗: The occurrence of leak within 30 days of the surgery

Intraoperative complications

时间窗: The occurrence of leak within 30 days of the surgery

Time of diagnosis of leak after surgery

时间窗: The occurrence of leak within 30 days of the surgery

次要结局

  • To analyze how anastomotic leaks affect hospital stay(Hospital stay is measured in terms of total number of days the patient was admitted in the hospital)

研究者

申办方类型
Private medical college

研究点 (1)

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