Evaluating the Safety and Efficacy of a Outpatient Appendectomy (PENDI_CSI)

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Status: Unknown

Conditions: Appendicitis Acute; Appendectomy

Treatments: Procedure: Hospitalization appendectomy (HA); Procedure: Outpatient (OA)

Study type: Interventional

Funder types: Other

Identifiers

NCT04464382

PENDI_CSI

Details and patient eligibility

About

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

Full 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.

Enrollment: 291 estimated patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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291 participants in 2 patient groups

Outpatient appendectomy

Experimental group

Description:

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.

Treatment:

Procedure: Outpatient (OA)

Hospitalization appendectomy

Active Comparator group

Description:

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.

Treatment:

Procedure: Hospitalization appendectomy (HA)