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Recruiting Not applicable NCT07521969

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

No applicable phase (e.g. observational)
Conditions: Appendicitis Acute Gangrenous Appendicitis

Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

trial.available_in: БГ
Overview
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.
Who can participate
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.
Interventions
outpatient surgery
OTHER
Hospitalization
OTHER
Locations 1
Spain (1)
Hospital Universitario Virgen del Rocío
Seville , Sevilla
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
14 Years
Healthy volunteers
No
Start date
01.11.2025
Completion date
01.11.2027
Registry ID
NCT07521969
Source
clinicaltrials.gov
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