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临床试验/NCT02083939
NCT02083939终止不适用

Prophylactic Antibiotic Treatment for Laparoscopic Inguinal Hernia Mesh Repair: Necessary or Not?

Sheba Medical Center1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2014年3月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
5
试验地点
1
主要终点
Incidence of surgical site infection

研究概览

简要总结

The purpose of this study is to find out whether it is necessary to prophylactically treat patients undergoing laparoscopic inguinal hernia repairs with antibiotics. Our hypothesis is that it is not necessary to pretreat patients with antibiotics if the operation is minimally invasive with a mesh placed at the defect.

详细描述

The investigators plan to follow up at least 100 patients who did not receive antibiotics prior to their inguinal hernia repair and compare their outcome to 100 patients who did receive prophylaxis. The investigators mainly will be analyzing the incidence of surgical site infections as evidenced by swelling, redness, pain, warmth or other signs deemed by the surgeon.

研究设计

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

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

  • Elective laparoscopic inguinal hernia repair, unilateral or bilateral

排除标准

  • Those requiring antibiotics for the surgery;
  • Those patients who have experienced surgical site infections from previous surgeries

结局指标

主要结局

Incidence of surgical site infection

时间窗: One year post-operation

The investigators will interview the patient at one week, at one month, and at one year post-operation and assess for any signs of infection around the location of hernia repair.

次要结局

未报告次要终点

研究者

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

Dr. Danny Rosin, MD

Attending Surgeon

Sheba Medical Center

研究点 (1)

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