Outpatient care after emergency surgery for gangrenous appendicitis
Safety, Efficacy, and Cost-effectiveness of Outpatient Surgery for Gangrenous Acute Appendicitis: The PENDI-CSI II Randomized Clinical Trial.
This trial will test whether people older than 14 with gangrenous appendicitis can be safely discharged home the same day after emergency appendectomy instead of staying in the hospital.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 122 (estimated) |
| Ages | 14 Years and up |
| Sex | All |
| Sponsor | Fundación Pública Andaluza para la gestión de la Investigación en Sevilla Academic / other |
| Locations | 1 site (Seville, Sevilla) |
| Trial ID | NCT07521969 on ClinicalTrials.gov |
What this trial studies
This randomized interventional trial at Hospital Universitario Virgen del Rocío compares same-day outpatient discharge to standard inpatient hospitalization for patients with intra-operatively confirmed gangrenous appendicitis. Eligible participants are adolescents and adults over 14 who meet criteria for outpatient discharge and can give informed consent, while patients with generalized purulent or faecaloid peritonitis, abscess, need for drains, immunosuppression, pregnancy, or inability to follow up are excluded. Outcomes include safety measures (postoperative complications and readmissions), recovery markers (oral tolerance, return to activities), and efficiency metrics (length of stay and resource use) over a defined postoperative follow-up period. Randomization occurs after emergency appendectomy once gangrenous appendicitis is confirmed during surgery.
Who should consider this trial
Good fit: Ideal candidates are patients over 14 with intra-operative confirmation of gangrenous appendicitis who tolerate oral intake, have no purulent/fecaloid peritonitis or abscess, do not require abdominal drains, are not immunosuppressed or pregnant, and have family support and ability to attend follow-up.
Not a fit: Patients with generalized purulent or faecaloid peritonitis, appendicular abscess, need for drainage, paralytic ileus, ASA IV or selected ASA III status, immunosuppression, active cancer, pregnancy, lack of family support, or inability to comply with follow-up are unlikely to benefit from outpatient discharge.
Why it matters
Potential benefit: If successful, the approach could shorten hospital stays, reduce healthcare costs, and allow suitable patients to recover at home sooner.
How similar studies have performed: Same-day discharge after uncomplicated appendectomy has been shown to be safe in other studies, but outpatient management specifically for gangrenous appendicitis has been less well studied.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Seville, Sevilla
- Hospital Universitario Virgen del Rocío — Seville, Sevilla, Spain (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.