Evaluating the Safety and Efficacy of a Outpatient Appendectomy

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

Conditions

• Appendicitis Acute
• Appendectomy

Interventions

PROCEDURE

Outpatient (OA)

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.

PROCEDURE

Hospitalization appendectomy (HA)

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.

Sponsors & Collaborators

• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

  lead OTHER

Principal Investigators

• Pareja C Felipe, PhD · Hospital Universitario Virgen del Rocio

• Padillo R Javier, PhD · Hospital Universitario Virgen del Rocio

• Durán MC Virginia María, MD · Hospital Universitario Virgen del Rocio

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

14 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-04-28

Primary Completion

2021-04-28

Completion

2021-10-28

Countries

• Spain

Study Locations