Endoscopic Management Of Iatrogenic Esophageal Perforation After Laparoscopic Upper Gastrointestinal Surgery

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2023
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.
Epistemonikos ID: e8ab24664a258e1fa8b00169014eded0924d8930
First added on: Feb 19, 2024