RecruitingNot ApplicableNCT07521969

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

Safety, Efficacy, and Cost-effectiveness of Outpatient Surgery for Gangrenous Acute Appendicitis: The PENDI-CSI II Randomized Clinical Trial.


Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Enrollment

122 participants

Start Date

Nov 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 14 Years

Inclusion Criteria4

  • 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 Criteria14

  • \- 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.

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Interventions

OTHERoutpatient surgery

outpatient surgery

OTHERHospitalization

Hospitalization after surgery


Locations(1)

Hospital Universitario Virgen del Rocío

Seville, Sevilla, Spain

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NCT07521969


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