Evaluating the Safety and Efficacy of a Outpatient Appendectomy

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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A Randomized Double-blind Clinical Trial to Evaluate the Safety and Efficacy of a Outpatient Appendectomy (PENDI_CSI)

Conditions
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Appendicitis Acute, Appendectomy

Intervention / Treatment
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* Procedure: Outpatient (OA)
* Procedure: Hospitalization appendectomy (HA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 14 years of age and who provide informed consent to participate in the study. Patients with non complicated acute appendicitis requiring and urgent appendectomy (laparoscopic or minimum incision) Negative appendicectomy. Exclusion Criteria: Complicated acute appendicitis (abscess, perforated, necrosis and peritonitis) Need to place intraoperative drainage. Patients with American Society of Anesthesiologists (ASA) >IV. Immunosuppressed patients. Pregnant. Possibility of inflammatory bowel disease. No family support. No informed consent signature. Impossibility to comply with the established follow-up

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Outpatient appendectomy<br>Patients with acute uncomplicated appendicitis that require emergency appendectomy. The intervention will be the classic.Once the appendectomy is performed, all the selection criteria will be reassessed and the definitive inclusion of the patients will be performed. Patients after surgery will go to the anesthetic recovery room without requiring hospital admission. The degree of satisfaction of the quality of the service and the care that must be completed before discharge and after surgery will be recorded. 1 phone review call will be made per month +/- 30 days in order to assess the safety and satisfaction of the procedure. | Procedure: Outpatient (OA)<br>* Patients who are candidates for OA and therefore pre-selected based on the primary data and characteristics of the clinical signs, will be admitted to the surgical observation in charge of our service. The patient will be informed in detail of the intervention to be performed and discharge on an outpatient basis and will sign the informed consent understanding and thus accepting all the information. The patient will undergo surgery using a laparoscopic or open technique with minimal incision. Once the appendectomy is performed, all the selection criteria will be reassessed and the definitive inclusion of the patients will be performed. In this case, we will perform the blind randomization of the patients. If all the inclusion requirements for the study are met, and the patient belongs to the OA group (case group), he will be discharged on an outpatient basis from the post-surgical stay unit without requiring hospital admission.<br>|
| Active Comparator: Hospitalization appendectomy<br>Patients with acute uncomplicated appendicitis that require emergency appendectomy. The intervention will be the classic.Once the appendectomy is performed, all the selection criteria will be reassessed and the definitive inclusion of the patients will be performed. Patients after surgery will go to the anesthetic recovery room and then be admitted to hospital beds, to be discharged within approximately 12 hours. 1 phone review call will be made per month +/- 30 days in order to assess the safety and satisfaction of the procedure. | Procedure: Hospitalization appendectomy (HA)<br>* Patients who are candidates for HA and therefore pre-selected based on the primary data and characteristics of the clinical signs, will be admitted to the surgical observation in charge of our service. The patient will be informed in detail of the intervention to be performed and discharge on an outpatient basis and will sign the informed consent understanding and thus accepting all the information. The patient will undergo surgery using a laparoscopic or open technique with minimal incision. Once the appendectomy is performed, all the selection criteria will be reassessed and the definitive inclusion of the patients will be performed. In this case, we will perform the blind randomization of the patients. If all the inclusion requirements for the study are met, and the patient belongs to the case group (HA), he will be admitted in hospital beds.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of ambulatory appendectomy patients that have ambulatory surgery | Analyze morbidity of appendectomy patients to determine the safety of ambulatory surgery | 20 months | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Rates of satisfaction | Measure the degree of satisfaction of our patients with outpatient management after appendectomy, using a satisfaction questionnaire. | 20 months | 
| 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 |