Out-patiente Management for Gangrenous Acute Appendicitis: The PENDI-CSI II Randomized Clinical Trial.
PENDI-CSI II
Safety, Efficacy, and Cost-effectiveness of Outpatient Surgery for Gangrenous Acute Appendicitis: The PENDI-CSI II Randomized Clinical Trial.
1 other identifier
interventional
122
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2025
CompletedStudy Start
First participant enrolled
November 1, 2025
CompletedFirst Posted
Study publicly available on registry
April 13, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2027
April 21, 2026
April 1, 2026
1.8 years
June 25, 2025
April 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Safety of outpatient management of patient with acute gangrenous appendicitis after laparoscopic appendectomy.
Numer of hospital readmission
1 month after surgery
Secondary Outcomes (6)
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)
Determine the causes of failure of the outpatient regimen in our patients.
30 days since the intervention
Association between baseline characteristics and failure of outpatient management within 30 days
30 days since the intervention
Time off work
30 days since surgery
Degree of satisfaction
30 days since surgery
- +1 more secondary outcomes
Study Arms (2)
Case
EXPERIMENTALOut management patient
Control
EXPERIMENTALhospitalised patient
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Universitario Virgen del Rocío
Seville, Sevilla, 41013, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2025
First Posted
April 13, 2026
Study Start
November 1, 2025
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
November 1, 2027
Last Updated
April 21, 2026
Record last verified: 2026-04