Endoscopic Management Of Iatrogenic Esophageal Perforation After Laparoscopic Upper Gastrointestinal Surgery : A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- incidence of leak after the intervention
研究概览
简要总结
The investigators included all patients who were presented to General Surgery Department with Iatrogenic Esophageal Perforation after Laparoscopic Upper Gastrointestinal Surgery at Zagazig University hospital between (December 2020 to August 2023).The sample size was calculated by using open Epi program depending on the following data ; confidence interval 95% , power of the test 80% , ratio of unexposed/ exposed 1 , the success rate of surgical repair versus endoscopic repair was 98 % versus 75% respectively. Odd ratio 16 , and risk ratio 1.3 , so the calculated sample size equal 84 patients divided into two equal groups. Included patients were randomized at a 1:1 ratio to "Endoscopic Group, EG" or "Surgical Group , SG" via the drawing of sealed envelopes containing computer-generated random numbers prepared by a third party before the start of the intervention.(simple random sample). Patients will be divided into 2 groups in accordance type of preoperative
Therapy :
Group 1: "Endoscopic Group, EG" included 42 patients. Group 2: "Surgical Group , SG" included 42 patients.
详细描述
A- Site of the study: The investigators included all patients who were presented to General Surgery Department with Iatrogenic Esophageal Perforation after Laparoscopic Upper Gastrointestinal Surgery at Zagazig University hospital between (December 2020 to August 2023).
B- Sample size:
The sample size was calculated by using open Epi program depending on the following data ; confidence interval 95% , power of the test 80% , ratio of unexposed/ exposed 1 , the success rate of surgical repair versus endoscopic repair was 98 % versus 75% respectively. Odd ratio 16 , and risk ratio 1.3 , so the calculated sample size equal 84 patients divided into two equal groups.
c- Sample selection: Included patients were randomized at a 1:1 ratio to "Endoscopic Group, EG" or "Surgical Group , SG" via the drawing of sealed envelopes containing computer-generated random numbers prepared by a third party before the start of the intervention.(simple random sample).
D- Subjects: Patients will be divided into 2 groups in accordance type of preoperative
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Iatrogenic Esophageal Perforation after Laparoscopic Upper Gastrointestinal Surgery
- •failued conservative meaures .
- •patient with good general condition (ASA I&II). -
排除标准
- •We excluded patients who bad general condition (ASAIII&IV&V),
- •respond to conservative measures.
结局指标
主要结局
incidence of leak after the intervention
时间窗: within one week after the procedure
incidence of leak after the intervention
次要结局
- incidence of side effects of endoscopy(within one month after the surgery)
研究者
Said Mohamed Said Abdou Negm
lecturer of general surgery
Zagazig University