About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
- Uncomplicated appendectomy.
Intra-operative purulent or faecaloid peritonitis
Appendicular abscess or plastron diagnosed by imaging.
Paralytic ileus preventing oral tolerance.
Trial design
Sequential
Treatments tested in this trial
outpatient surgery
Other interventionoutpatient surgery
Hospitalization
Other interventionHospitalization after surgery
Treatment groups
Trial outcomes
Primary outcomes
Safety of outpatient management of patient with acute gangrenous appendicitis after laparoscopic appendectomy.
Numer of hospital readmission
Secondary outcomes
Number of participants achieving discharge criteria based on the Modified Aldrete Score (range 0-10, higher scores indicate better recovery) after appendectomy
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.
Record of the causes of failure of the outpatient system
Association between baseline characteristics and failure of outpatient management within 30 days
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
Time until patients fully return to work
Sponsors and contacts
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