Evaluating the Safety and Efficacy of a Outpatient Appendectomy

Not Applicable

• Conditions: Appendectomy; Appendicitis Acute
• Interventions: Procedure: Hospitalization appendectomy (HA); Procedure: Outpatient (OA)

• Registration Number: NCT04464382
• Lead Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2019-04-28
• Study First Submitted: 2020-02-11
• Status Verified: 2020-07
• Study First Submitted QC: 2020-07-06
• Study First Posted: 2020-07-09
• Last Update Submitted: 2021-01-12
• Last Update Posted: 2021-01-13
• Primary Completion: 2021-04-28
• Study Completion: 2021-10-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 291

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hospitalization appendectomy	Hospitalization appendectomy (HA)	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.
Outpatient appendectomy	Outpatient (OA)	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.

Primary Outcome Measures

Name	Time	Method
Rates of ambulatory appendectomy patients that have ambulatory surgery	20 months	Analyze morbidity of appendectomy patients to determine the safety of ambulatory surgery
Rates of readmission of appendectomy patients that had ambulatory surgery	20 months	Analyze rates of readmission of appendectomy patients to determine the safety of ambulatory surgery

Secondary Outcome Measures

Name	Time	Method
Prevalence of ambulatory appendectomy patients	20 months	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.
Media of time until the total incorporation to the activities of the daily life after appendectomy	20 months	To value the time until the total incorporation to the activities of the daily life after appendectomy.
Rates of satisfaction	20 months	Measure the degree of satisfaction of our patients with outpatient management after appendectomy, using a satisfaction questionnaire.
Costs of the outpatient regimen versus the hospitalization of patients	20 months	Compare the costs of the outpatient regimen versus the hospitalization of patients with uncomplicated acute appendicitis (cost-minimization analysis).

Trial Locations

Locations (1)

Hospital Universitario Virgen Del Rocio; 🇪🇸 Sevilla, Spain