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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04464382
Other study ID # PENDI_CSI
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 28, 2019
Est. completion date October 28, 2021

Study information

Verified date July 2020
Source Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Contact Pareja C Felipe, PhD
Phone +34630962443
Email felipe.pareja67@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study evaluates the Safety and Efficacy of a outpatient appendectomy. Half of participants will be perform the hospitalization, while the other half will undergo the outpatient appendectomy


Description:

Acute appendicitis (AA) is one of the most common causes of acute abdomen and one of the most frequent diagnoses that require urgent surgery worldwide. Many laparoscopic procedures are currently performed on an outpatient basis.Laparoscopic appendectomy, however, continues to require postoperative hospitalization averaging between 1 and 2 days, at most institutions. At present ambulatory laparoscopic appendectomy (LA) are gained popularity due to the improved understanding of patient selection criteria, the application of enhanced recovery pathways, and the potential for improving healthcare resource utilization. There are few studies about to compare the morbidity and readmission rates between ambulatory and conventional LA. There is a lack of high-quality comparative studies making conclusive recommendations not possible at this time. Based on current data, ambulatory LA may be safe and feasible as compared with conventional LA.


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Study Design


Related Conditions & MeSH terms


Intervention

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Locations

Country Name City State
Spain Hospital Universitario Virgen Del Rocio Sevilla

Sponsors (1)

Lead Sponsor Collaborator
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Country where clinical trial is conducted

Spain, 

References & Publications (6)

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Outcome

Type Measure Description Time frame Safety issue
Primary Rates of ambulatory appendectomy patients that have ambulatory surgery Analyze morbidity of appendectomy patients to determine the safety of ambulatory surgery 20 months
Primary Rates of readmission of appendectomy patients that had ambulatory surgery Analyze rates of readmission of appendectomy patients to determine the safety of ambulatory surgery 20 months
Secondary Prevalence of ambulatory appendectomy patients Measure the percentage of ambulatory surgery and uncomplicated acute appendicitis vs the percentage of ambulatory surgery in failure patients with the same pathology e.g.
Uncontrolled abdominal pain with analgesia.
Upper airway discomfort related to intubation that is not controlled with medication.
Pain in the back or shoulders in relation to the pneumoperitoneum that are in patients with not controlled with the medication.
Hemodynamically abnormal. Uncontrolled bleeding at the level of any of the wounds. Need for reoperation. Need to re-enter or consult the Emergency Service No spontaneous urination.
Nausea / vomiting.
Oral intolerance.
No wandering.
Insecurity or fear of the patient at discharge.
20 months
Secondary Media of time until the total incorporation to the activities of the daily life after appendectomy To value the time until the total incorporation to the activities of the daily life after appendectomy. 20 months
Secondary Rates of satisfaction Measure the degree of satisfaction of our patients with outpatient management after appendectomy, using a satisfaction questionnaire. 20 months
Secondary Costs of the outpatient regimen versus the hospitalization of patients Compare the costs of the outpatient regimen versus the hospitalization of patients with uncomplicated acute appendicitis (cost-minimization analysis). 20 months
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