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临床试验/NCT01565993
NCT01565993
终止
不适用

Is the Use of Prophylactic Hemoclips in the Endoscopic Resection of Large Pedunculated Polyps Useful? A Prospective and Randomized Study

Hospital Severo Ochoa1 个研究点 分布在 1 个国家目标入组 108 人2007年7月

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Postpolypectomy Bleeding
发起方
Hospital Severo Ochoa
入组人数
108
试验地点
1
主要终点
The Number of Polyps With Complications After Polypectomy (The Total Complication Rate)
状态
终止
最后更新
13年前

概览

简要总结

The aim of our study is to analyze the advantages of the prophylactic use of hemoclips before polypectomy in our usual clinical practice, through a prospective randomized study that determines their effectiveness compared to conventional polypectomy, assessing the decrease in immediate and delayed post-polypectomy bleeding

详细描述

The methods for preventing post-polypectomy bleeding (PPB) are not standardised and there are groups that use hemoclips for this purpose. The aim of our study is to analyze whether the use of hemoclips reduces PPB complications. It is a prospective, randomised study of patients with pedunculated polyps larger than 10mm. The patients were included in two groups (hemoclip before polypectomy -HC- and standard polypectomy -SP-)

注册库
clinicaltrials.gov
开始日期
2007年7月
结束日期
2010年8月
最后更新
13年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
Hospital Severo Ochoa
责任方
Principal Investigator
主要研究者

Elvira Quintanilla

Physician

Hospital Severo Ochoa

入排标准

入选标准

  • Patients with one or more pedunculated polyps, the heads of which measured more than 1cm (regardless of the stalk thickness and length), and they were compared against the size of the biopsy forceps (6mm) and subsequently confirmed in the anatomical specimen
  • Not to have any hemostatic alterations at the time the endoscopy was performed (confirmed by the usual blood tests taken before the procedure).

排除标准

  • Patients younger than 18 years of age
  • Patients with a platelet count of less than 50000, INR larger than 1.5
  • Patients who refused to give their informed consent.

结局指标

主要结局

The Number of Polyps With Complications After Polypectomy (The Total Complication Rate)

时间窗: Between four and six weeks after the polypectomy, the patients were contacted by phone in order to confirm the absence of delayed bleeding

In order to test the ability of prophylactic hemoclipping to prevent post-polypectomy bleeding, the investigators were required to register all the adverse events that occurred. These adverse events were called "complications", despite their severity and clinical significance

次要结局

  • Difficult to Place the Clip(During endoscopic procedure was performed (between 2007 and 2010: period over which the study was conducted))

研究点 (1)

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