Clinical Trial for a Outpatient Clinical Management of Urgent Laparoscopic Appendectomy (ASI)

HJ23

Status: Completed

Conditions: Appendicitis; Appendicitis Acute

Treatments: Other: hospitalization; Other: Outpatient

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05401188

1

Details and patient eligibility

About

The aim of this study is to evaluate the safety and efficacy of outpatient management of uncomplicated acute appendicitis. For this purpose, a randomized clinical trial was designed. Selected patients who have undergone surgery for acute appendicitis are randomized into two groups. One group with hospitalization and another group without admission.

Full description

The aim of this study is to evaluate the efficacy and safety of outpatient management of laparoscopic appendicectomy in uncomplicated acute appendicitis.

This was a single center randomized controlled clinical trial consisting in 2 treatment groups. Patients were recruited in University Hospital of Tarragona Joan XXIII of Spain.

All patients admitted in the emergency department at University Hospital of Tarragona Joan XXIII with acute appendicitis diagnosis were likely to enter in the study. All patients who accomplished at least 4 over 5 of the Saint-Antoine criteria were included. The 5 criteria were: Leukocytosis lower than 15.000; C-Reactive protein lower than 30mg; Body mass index lower than 30kg/m2; appendicular diameter lower than 10mm and no radiological sign of complication.

All patients who met the inclusion criteria and none of the exclusion criteria were admitted to the study for emergency surgery.

In order to avoid the biases a unique anesthetic and surgical protocol were established for both groups.

Once Laparoscopic appendicectomy was performed the patients were randomly assigned to the hospitalization group or outpatient group.

Patients in the hospitalization group were admitted in the hospitalization ward. Patients in the outpatient group were referred to the day-surgery unit where they were discharged according to ALDRETE criteria.

The primary endpoint was the length of hospital stay (LHS). The length of hospital stay was calculated from the day and hour of admission in the surgical area to the day and hour of discharge, based on the hours of hospital stay. Secondary endpoints included the failures of the outpatient management, readmissions and the hospitals cost.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients over 18 years old
• meet at least 4 over 5 Saint Antoine criteria
• ASA classification (American Society of Anesthesiologists) less than or equal to 3
• patients who live accompanied in a home at a maximum distance of 30 minutes from the hospital and an adequate cognitive capacity.

Exclusion criteria

• pregnancy or breastfeeding
• complicated Acute Appendicitis
• surgical management performed in more 90 minutes.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

hospitalization group

Active Comparator group

Description:

Patients in the hospitalization group, once the surgical intervention was finished, were transferred to the postoperative recovery unit and later they were discharged to the usual hospital ward. Patients received adequate intravenous fluid resuscitation based on their individual hemodynamic parameter and fluid balance, and they received analgesia according to personal requirement. In the hospital ward, the usual patient management protocols were followed until a complete recovery and consequently discharged according to the usual criteria.

Treatment:

Other: hospitalization

outpatient group

Experimental group

Description:

Patients in the outpatient group , once operated, were transferred to the surgery unit without admission and were later discharged home if they met the ALDRETE criteria in less than 23 hours after the intervention (following the surgery criteria without admission stages). If the patient was operated during the night shift, following the advice of major outpatient surgery where overnight stays are allowed, the patient was admitted to the post-anesthetic recovery unit and discharged the next day, always in less than 23 hours. In case of being discharged after 23 hours or not meeting ALDRETE criteria, it was considered a failure of the outpatient treatment.

Treatment:

Other: Outpatient