Appendicitis Acute, Gangrenous Appendicitis
Conditions
Brief summary
PHASE II-III CLINICAL TRIAL TO EVALUATE THE SAFETY, EFFECTIVENESS AND EFFICIENCY OF DISCHARGE TO OUTPATIENT SURGERY IN PATIENTS WITH ACUTE GANGRENOUS APPENDICITIS UNDERGOING EMERGENCY SURGERY.
Interventions
OTHERoutpatient surgery
outpatient surgery
OTHERHospitalization
Hospitalization after surgery
Sponsors
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Acute gangrenous appendicitis confirmed during surgery. * Patient who meets the criteria to be discharged on an outpatient basis * Signature of informed consent. * Older than 14 years of age
Exclusion criteria
* \- Uncomplicated appendectomy. * Intra-operative purulent or faecaloid peritonitis * Appendicular abscess or plastron diagnosed by imaging. * Paralytic ileus preventing oral tolerance. * Need for placement of abdominal drainage. * ASA IV and some selected ASA III. * Immunosuppression. * Patients with active neoplasia. * Pregnancy. * Doubts in the definitive diagnosis. * Suspicion of inflammatory bowel disease. * No family support. * Failure to sign the informed consent form. * Impossibility to comply with the follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of outpatient management of patient with acute gangrenous appendicitis after laparoscopic appendectomy. | 1 month after surgery | Numer of hospital readmission |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants achieving discharge criteria based on the Modified Aldrete Score (range 0-10, higher scores indicate better recovery) after appendectomy | Immediately postoperatively (before discharge) | The Modified Aldrete Score assesses recovery after anesthesia (range 0-10). Participants meeting predefined discharge criteria (e.g., score ≥9) will be considered eligible for outpatient management. Results will be reported as number and percentage of participants. |
| Determine the causes of failure of the outpatient regimen in our patients. | 30 days since the intervention | Record of the causes of failure of the outpatient system |
| Association between baseline characteristics and failure of outpatient management within 30 days | 30 days since the intervention | The relationship between baseline demographic and clinical variables and outpatient management failure will be assessed using appropriate statistical methods (e.g., logistic regression). Results will be reported as odds ratios with 95% confidence intervals. |
| Time off work | 30 days since surgery | Time until patients fully return to work |
| Degree of satisfaction | 30 days since surgery | To measure the degree of satisfaction expressed by our patients with outpatient management after laparoscopic appendectomy, using a 14-item patient satisfaction questionnaire based on a 4-point Likert scale (minimum score 1, maximum score 4 per item), where higher scores indicate greater satisfaction (better outcome). |
| Efficiency of outpatient management | 30 days since surgery | Compare the costs of outpatient care versus hospitalization for patients with acute gangrenous appendicitis undergoing laparoscopic surgery (cost-minimization analysis). |
Countries
Spain
Outcome results
None listed