Actively Recruiting

Phase Not Applicable
Age: 14Years +
All Genders
NCT07521969

Out-patiente Management 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

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 14Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

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 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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hospital Universitario Virgen del Rocío

Seville, Sevilla, Spain, 41013

Actively Recruiting

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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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