Actively Recruiting
Safety, Efficacy, and Cost-effectiveness of Outpatient Surgery for Gangrenous Acute Appendicitis: The PENDI-CSI II Randomized Clinical Trial.
Led by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Updated on 2026-04-21
122
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, effectiveness, and cost-efficiency of managing patients with acute gangrenous appendicitis through outpatient surgery after emergency laparoscopic appendectomy. This randomized clinical trial compares outpatient discharge with traditional hospitalization to understand which approach works best for this condition. Participants are randomly assigned to either outpatient surgery management or hospitalization after surgery. The outpatient group will be discharged based on specific recovery criteria, while the hospitalized group will stay in the hospital following their procedure. The study carefully monitors each group's recovery and discharge processes to assess differences. During the study, participants are assessed immediately after surgery for recovery using the Modified Aldrete Score and monitored up to 30 days post-surgery for safety, causes of outpatient management failure, time taken off work, satisfaction levels, and overall efficiency. Researchers also review baseline characteristics to understand factors affecting outpatient management success. The total follow-up period includes one month after surgery for safety evaluation.
CONDITIONS
Brief Title
Out-patiente Management for Gangrenous Acute Appendicitis: The PENDI-CSI II Randomized Clinical Trial.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Acute gangrenous appendicitis confirmed during surgery
- Meets criteria for discharge on an outpatient basis
- Signed informed consent
- Age 14 years or older
You will not qualify if you...
- Uncomplicated appendectomy
- Intra-operative purulent or faecaloid peritonitis
- Appendicular abscess or plastron diagnosed by imaging
- Paralytic ileus preventing oral tolerance
- Need for abdominal drainage placement
- ASA IV and some selected ASA III patients
- Immunosuppression
- Active neoplasia
- Pregnancy
- Doubts in definitive diagnosis
- Suspicion of inflammatory bowel disease
- No family support
- Failure to sign informed consent
- Inability to comply with follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants undergo laparoscopic appendectomy for gangrenous acute appendicitis and receive immediate care after surgery.
1 surgery day visit (in-person)
Duration - Up to 30 days since surgery
Participants are managed either as outpatients or hospitalized patients depending on their assigned group and recovery status after surgery.
Visits as needed based on recovery; outpatient or hospital monitoring
Trial Site Locations
Total: 1 location
1
Hospital Universitario Virgen del Rocío
Seville, Sevilla, Spain, 41013
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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