Acute Appendicitis, Appendicitis Perforated, Appendicitis Suppurative
Conditions
Brief summary
The aim of this study is to evaluate the safety and efficacy of outpatient management of complicated 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.
Detailed description
The aim of this study is to evaluate the efficacy and safety of outpatient management of laparoscopic appendicectomy in complicated 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 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
Interventions
BEHAVIORALHospitalization
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
BEHAVIORALOutpatient
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.
Sponsors
Hospital Universitari Joan XXIII de Tarragona.
HJ23
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* patients over 18 years old * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| length of hospital stay (LHS) | 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
| Measure | Time frame | Description |
|---|---|---|
| failures of the outpatient management | 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. |
| readmissions | 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. |
| hospitals cost | 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 |
Contacts
Primary ContactJordi Elvira Lopez, MD, PhD
Outcome results
None listed