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RecruitingNCT07521969PENDI-CSI IIUpdated Apr 21, 2026

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

An interventional study of outpatient surgery and Hospitalization in Appendicitis Acute and Gangrenous Appendicitis, sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla. Recruiting at 1 site in Spain. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2026-04-21.

Sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Nov 2025; still recruiting 1 year later.
Phase
Not applicable
Study type
Interventional
Enrollment
122
Allocation
Randomized
Ages
14 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Appendicitis Acute
  • Gangrenous Appendicitis

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03

In context

Appendicitis

419 studies on the registry are indexed under Appendicitis; 67 are open to participants now.

This study's planned enrollment of 122 is close to the median of 111 across 252 interventional studies indexed under Appendicitis.

Browse Appendicitis studies →

Lead sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla is the lead sponsor of 120 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
14 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Acute gangrenous appendicitis confirmed during surgery.
  • Patient who meets the criteria to be discharged on an outpatient basis
  • Signature of .
  • Older than 14 years of age

Exclusion criteria

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.
  • and some selected ASA III.
  • .
  • Patients with active neoplasia.
  • Pregnancy.
  • Doubts in the definitive diagnosis.
  • Suspicion of inflammatory bowel disease.
  • No family support.
  • Failure to sign the form.
  • Impossibility to comply with the follow-up.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
122 participants (estimated)

Study arms

  • Experimental
    Case

    Out management patient

    Other: outpatient surgery

  • Experimental
    Control

    hospitalised patient

    Other: Hospitalization

Interventions

  • Otheroutpatient surgery

    outpatient surgery

  • OtherHospitalization

    Hospitalization after surgery

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What researchers measure

Primary outcomes

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

    Numer of hospital readmission

    Time frame: 1 month after surgery

Secondary outcomes

  1. Number of participants achieving discharge criteria based on the Modified Aldrete Score (range 0-10, higher scores indicate better recovery) after appendectomy

    The Modified Aldrete Score assesses recovery after anesthesia (range 0-10). Participants meeting predefined discharge criteria (e.g., score ≥9) will be considered eligible for outpatient management. Results will be reported as number and percentage of participants.

    Time frame: Immediately postoperatively (before discharge)

  2. Determine the causes of failure of the outpatient regimen in our patients.

    Record of the causes of failure of the outpatient system

    Time frame: 30 days since the intervention

  3. Association between baseline characteristics and failure of outpatient management within 30 days

    The relationship between baseline demographic and clinical variables and outpatient management failure will be assessed using appropriate statistical methods (e.g., logistic regression). Results will be reported as odds ratios with 95% confidence intervals.

    Time frame: 30 days since the intervention

  4. Time off work

    Time until patients fully return to work

    Time frame: 30 days since surgery

  5. Degree of satisfaction

    To measure the degree of satisfaction expressed by our patients with outpatient management after laparoscopic appendectomy, using a 14-item patient satisfaction questionnaire based on a 4-point Likert scale (minimum score 1, maximum score 4 per item), where higher scores indicate greater satisfaction (better outcome).

    Time frame: 30 days since surgery

  6. Efficiency of outpatient management

    Compare the costs of outpatient care versus hospitalization for patients with acute gangrenous appendicitis undergoing laparoscopic surgery (cost-minimization analysis).

    Time frame: 30 days since surgery

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Study locations

1 of 1 sites recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07521969
Responsible party
Sponsor
First posted
Apr 13, 2026
Start date
Nov 1, 2025
Primary completion
Sep 1, 2027 (estimated)
Completion
Nov 1, 2027 (estimated)
Last update
Apr 21, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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