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Clinical Trial for a Outpatient Clinical Management for Complicated Acute Appendicitis — ASI2  

Acute Appendicitis Clinical Trial

Official title:
Randomized Clinical Trial to Test the Efficacy and Safety of Outpatient Clinical Management of Urgent Laparoscopic Appendectomy in Complicated Acute Appendicitis

Clinical Trial Summary

The aim of this study is to evaluate the safety and efficacy of outpatient management of complicated acute appendicitis. For this purpose, a randomized clinical trial was designed. Selected patients who have undergone surgery for acute appendicitis are randomized into two groups. One group with hospitalization and another group without admission.

Clinical Trial Description

The aim of this study is to evaluate the efficacy and safety of outpatient management of laparoscopic appendicectomy in complicated acute appendicitis. This was a single center randomized controlled clinical trial consisting in 2 treatment groups. Patients were recruited in University Hospital of Tarragona Joan XXIII of Spain. All patients admitted in the emergency department at University Hospital of Tarragona Joan XXIII with acute appendicitis diagnosis were likely to enter in the study. All patients who met the inclusion criteria and none of the exclusion criteria were admitted to the study for emergency surgery. In order to avoid the biases a unique anesthetic and surgical protocol were established for both groups. Once Laparoscopic appendicectomy was performed the patients were randomly assigned to the hospitalization group or outpatient group. Patients in the hospitalization group were admitted in the hospitalization ward. Patients in the outpatient group were referred to the day-surgery unit where they were discharged according to ALDRETE criteria. The primary endpoint was the length of hospital stay (LHS). The length of hospital stay was calculated from the day and hour of admission in the surgical area to the day and hour of discharge, based on the hours of hospital stay. Secondary endpoints included the failures of the outpatient management, readmissions and the hospitals cost ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06059365
Study type Interventional
Source HJ23
Contact Jordi Elvira Lopez, MD, PhD
Phone 0034686917760
Email jelvira.hj23.ics@gencat.cat
Status Not yet recruiting
Phase N/A
Start date November 1, 2023
Completion date November 1, 2023
View Details
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