Skip to main content
OpenTrials
Completed

NCT Number: NCT05401188

Clinical Trial for a Outpatient Clinical Management of Urgent Laparoscopic Appendectomy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Appendicitis Acute Appendicitis Cecal Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Infections Intestinal Diseases Intraabdominal Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jordi Elvira Lopez

Tarragona, 43005, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Outpatient

Other

Once the patient was operated and an uncomplicated appendicitis was confirmed, the patient was randomized to one of the two experimental branches: the hospitalization group (HG) or outpatient group (OG). Patients in the OG were referred to the day-surgery unit where they were discharged according to ALDRETE criteria.

Hospitalization

Other

Once the patient was operated and an uncomplicated appendicitis was confirmed, the patient was randomized to one of the two experimental branches: the hospitalization group (HG) or outpatient group (OG). In this group, were admitted in the hospitalization ward.

Primary outcomes

  1. length of hospital stay (LHS)

    Time frame: up to 5 days

    The length of hospital stay (LHS) was calculated from the date and time of urgent appendectomy surgery to the date and time of hospital discharge, based on the hours of hospital stay (assessed up to 5 days)

Secondary outcomes

  1. failures of the outpatient management

    Time frame: assessed up to 30 days

    Once the patients were discharged home, they were evaluated for emergency room visit. From the date of hospital discharge to the day of emergency room visit. The presence of a emergency room visit is considered as a Failure of the outpatient management.

  2. readmissions

    Time frame: assessed up to 30 days

    Once the patients were discharged home, they were evaluated for readmission to the hospital ward. From the date of hospital discharge to the day of readmission to the hospital ward. The re-admission to the hospitalization ward was considered a readmission.

  3. hospitals cost

    Time frame: through study completion, an average of 1 year

    The economic costs of both clinical managements were evaluated until the end of the study, a mean of 1 year. For the study, the direct and indirect costs of laparoscopic surgery, consumable material, economic expenses in the hospital ward, and the cost of the price of the emergency room visit were evaluated. The hospital's economic department was contacted and they calculated the cost in euros per patient. Each group was evaluated separately and a comparison was made.

Sponsors and collaborators

Lead sponsor

HJ23

Industry

Collaborators

  • Hospital Universitari Joan XXIII de Tarragona.

Registry information

Official study title

Randomized Clinical Trial to Test the Efficacy and Safety of Outpatient Clinical Management of Urgent Laparoscopic Appendectomy in Uncomplicated Acute Appendicitis

Acronym: ASI

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Jun 2, 2022
Registry last updated
Jun 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.