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临床试验/NCT05051683
NCT05051683已完成不适用

Combined Endoscopic & Radiologic Intervention For Management Of Acute Perforated Peptic Ulcer : A Randomized Controlled Trial

Zagazig University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年12月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
incidence of complications after combined endoscopic & radiologic intervention

研究概览

简要总结

The investigators included all patients who were developed acute perforated peptic ulcer manifestations and were admitted to our hospital between December 2019 to August 2021. The study was approved by the research and Ethics committee of our university and performed in accordance with the code of ethics of the world medical association (Declaration of Helsinki) for studies involving humans. A written informed consent was obtained from all participants. The sample size was calculated using open Epi program using the following data ; confidence interval 95% , power of test 80% , ratio of unexposed/exposed 1, percent of patients with successful management of acute perforated peptic ulcer by surgical intervention 90% and those with successful management by endoscopy 99% , odds ratio 99%, and risk ratio 2 , so the calculated sample size equal 100 patients divided into two equal groups. Group (1) included 50 patients managed by combined endoscopic & radiologic intervention , group (2) included 50 patients managed by surgery.

详细描述

The investigators included all patients who were developed acute perforated peptic ulcer manifestations and were admitted to our hospital between December 2019 to August 2021. The study was approved by the research and Ethics committee of our university and performed in accordance with the code of ethics of the world medical association (Declaration of Helsinki) for studies involving humans. A written informed consent was obtained from all participants. The sample size was calculated using open Epi program using the following data ; confidence interval 95% , power of test 80% , ratio of unexposed/exposed 1, percent of patients with successful management of acute perforated peptic ulcer by surgical intervention 90% and those with successful management by endoscopy 99% , odds ratio 99%, and risk ratio 2 , so the calculated sample size equal 100 patients divided into two equal groups. Group (1) included 50 patients managed by combined endoscopic & radiologic intervention , group (2) included 50 patients managed by surgery. Any patients with acute perforated peptic ulcer manifestations and age over 18 years were included. Patients presented with septic shock and age below 18 years were excluded.

Perioperative measures:

In this prospective randomized controlled trial , all patients were subjected to the followings: patients were selected by randomization method , Full history taking , Complete physical examination , laboratory investigations ( complete blood picture , liver and kidney functions , coagulation profile ) , radiological investigations ( chest x- ray erect , abdominal & pelvic u/s ).

Surgical techniques :

Traditional surgical exploration and Graham omental patch repair with abdominal lavage either open or laparoscopy was done for group (2). For group (1) endoscopic management using stent , clipping and sewing combined with radiologic interventional drainage was used. For duodenal ulcer only metallic stent was used due to narrow space while for gastric ulcer either stent , clipping and sewing were used due to capacious space.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

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

  • Any patients with acute perforated peptic ulcer manifestations . _ age over 18 years.

排除标准

  • Patients presented with septic shock . _ age below 18 years

结局指标

主要结局

incidence of complications after combined endoscopic & radiologic intervention

时间窗: within one week after the endoscopy

incidence of complications after combined endoscopic \& radiologic intervention

次要结局

  • incidence of mortality after combined endoscopic & radiologic intervention(within one month after the endoscopy)

研究者

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

Said Mohamed Said Abdou Negm

lecturer of general surgery

Zagazig University

研究点 (2)

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