NCT07521969 Out-patiente Management for Gangrenous Acute Appendicitis: The PENDI-CSI II Randomized Clinical Trial.
| NCT ID | NCT07521969 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundación Pública Andaluza para la gestión de la Investigación en Sevilla |
| Condition | Appendicitis Acute |
| Study Type | INTERVENTIONAL |
| Enrollment | 122 participants |
| Start Date | 2025-11-01 |
| Primary Completion | 2027-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 122 participants in total. It began in 2025-11-01 with a primary completion date of 2027-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Frequently Asked Questions
Who can join the NCT07521969 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, studying Appendicitis Acute. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07521969 currently recruiting?
Yes, NCT07521969 is actively recruiting participants. Visit ClinicalTrials.gov or contact Fundación Pública Andaluza para la gestión de la Investigación en Sevilla to inquire about joining.
Where is the NCT07521969 trial being conducted?
This trial is being conducted at Seville, Spain.
Who is sponsoring the NCT07521969 clinical trial?
NCT07521969 is sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla. The trial plans to enroll 122 participants.