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

Recruiting now · Not applicable

Conditions studied: Appendicitis Acute, Gangrenous Appendicitis

In brief

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.

Key facts

Study ID

NCT07521969

Run by

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

People needed

122

Starts

2025-11-01

Expected to finish

2027-11-01

Last updated by the study team

2026-04-21

Who can join

Age: 14 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Hospital Universitario Virgen del Rocío — Seville, Sevilla, Spain (enrolling)

Full record on ClinicalTrials.gov

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