RecruitingNot Applicable

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

Spain122 participantsStarted 2025-11-01

Plain-language 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.

Who can participate

Age range

14 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety of outpatient management of patient with acute gangrenous appendicitis after laparoscopic appendectomy.

Timeframe: 1 month after surgery

Trial details

NCT IDNCT07521969

SponsorFundación Pública Andaluza para la gestión de la Investigación en Sevilla

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09-01

View on ClinicalTrials.gov More Appendicitis Acute trials

Who can participate

Age range

14 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.