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Clinical Trials in Spain / NCT07521969
Recruiting Not applicable

Out-patiente Management for Gangrenous Acute Appendicitis: The PENDI-CSI II Randomized Clinical Trial.

NCT07521969 · tracked via the Priya Life Science Spain tracker
Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Phase
Not applicable
Started
2025-11-01
Last updated
2026-04-21

Condition(s) studied

Appendicitis AcuteGangrenous Appendicitis

Investigational drug(s) / intervention(s)

outpatient surgeryHospitalization

outpatient surgery: outpatient surgery

Hospitalization: Hospitalization after surgery

Study 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.

Eligibility

Sex
ALL
Min age
14 Years
Max age
—
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.

Primary outcome measure(s)

  • Safety of outpatient management of patient with acute gangrenous appendicitis after laparoscopic appendectomy. — 1 month after surgery
    Numer of hospital readmission

Trial sites (1)

FacilityCityRegionStatus
Hospital Universitario Virgen del Rocío Seville Sevilla Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07521969 on ClinicalTrials.gov ↗ ← All trials in Spain