Recruiting NCT07521969
Out-patiente Management for Gangrenous Acute Appendicitis: The PENDI-CSI II Randomized Clinical Trial.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: outpatient surgery, Hospitalization.
- Who it may be relevant to
- Registry conditions: Appendicitis Acute, Gangrenous Appendicitis. Basic parameters: from 14 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Safety, Efficacy, and Cost-effectiveness of Outpatient Surgery for Gangrenous Acute Appendicitis: The PENDI-CSI II Randomized Clinical Trial.
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.
Interventions
- Other outpatient surgery
outpatient surgery - Other Hospitalization
Hospitalization after surgery
Primary outcome measures
- Safety of outpatient management of patient with acute gangrenous appendicitis after laparoscopic appendectomy. [Time frame: 1 month after surgery]
Secondary outcome measures (6)
- Number of participants achieving discharge criteria based on the Modified Aldrete Score (range 0-10, higher scores indicate better recovery) after appendectomy [Time frame: Immediately postoperatively (before discharge)]
- Determine the causes of failure of the outpatient regimen in our patients. [Time frame: 30 days since the intervention]
- Association between baseline characteristics and failure of outpatient management within 30 days [Time frame: 30 days since the intervention]
- Time off work [Time frame: 30 days since surgery]
- Degree of satisfaction [Time frame: 30 days since surgery]
- Efficiency of outpatient management [Time frame: 30 days since 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Spain · 1 center
- Hospital Universitario Virgen del Rocío — Seville
Identifiers
NCT: NCT07521969 · PENDI-CSI II