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临床试验/NCT02069262
NCT02069262已完成不适用

Angiography Combination Laparoscopy in Patients With Obscure Gastrointestinal Bleeding

The Second People's Hospital of GuangDong Province1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2003年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
66
试验地点
1
主要终点
diagnostic yield of angiography combination laparoscopy and mesenteric angiography alone in identifying the source of bleeding

研究概览

简要总结

There were many approaches for patients with obscure gastrointestinal bleeding (OGIB). Capsule endoscopy (CE), double-balloon endoscopy, deep small-bowel spiral enteroscopy, laparoscopy, computed tomography and angiography have been recommended as investigation. However, of these techniques, the evaluation and management of patients with OGIB remains a formidable challenge. We compared the diagnostic yield and long-term outcomes of patients with OGIB randomized to angiogram combination laparoscopy or angiogram alone.

详细描述

Consecutive patients who presented with OGIB to the second people's hospital of GuangDong province between January 2003 and November 2008 were recruited. This study was approved by the ethical committee of the Second people's Hospital of GuangDong Province and was designed according to the CONSORT (Consolidated Standards of Reporting Trials) guidelines. All patients gave written informed consent before beginning the study. As a standard protocol, all patients presented with melena or hematochezia would receive at least 2 times upper gastrointestinal endoscopy before admission. Patients who had nondiagnostic upper GI endoscopy were also offered at least 2 times colonoscopy before admission. All gastrointestinal endoscopies were performed by experienced endoscopists (hanning Wang). OGIB were defined as patients who had nondiagnostic upper endoscopy and colonoscopy.

Patients who were < 18 years, pregnant, in moribund conditions, or with terminal malignancy were excluded. Patients with contrast allergy and impaired renal function (serum creatinine > 150 µmol/l) were also not eligible for this study. All patients were randomized to receive either mesenteric angiography alone or angiography combination laparoscopy in a 1:1 ratio. Randomization was performed computer-generated list using a randomly permuted block design. To ensure concealed randomization, the randomization code was put in opaque envelope and kept by researchers not performing angiography or angiography combination laparoscopy. Both patients and investigators were unaware of the randomization sequence.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • melena or hematochezia receive at least 2 times upper gastrointestinal endoscopy nondiagnostic upper GI endoscopy were also offered at least 2 times colonoscopy endoscopies were performed by experienced endoscopists.

排除标准

  • < 18 years, pregnant moribund conditions terminal malignancy contrast allergy impaired renal function (serum creatinine > 150 µmol/l)

结局指标

主要结局

diagnostic yield of angiography combination laparoscopy and mesenteric angiography alone in identifying the source of bleeding

时间窗: 5 years after initial examination

The primary outcome of this study was the diagnostic yield of angiography combination laparoscopy and mesenteric angiography alone in identifying the source of bleeding.

次要结局

  • rebleeding rates(follow-up to 5 years)

研究者

发起方
The Second People's Hospital of GuangDong Province
申办方类型
Other
责任方
Principal Investigator
主要研究者

KaiYun Chen

Doctor

The Second People's Hospital of GuangDong Province

研究点 (1)

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