Appendicitis AcutePENDI-CSI IINCT07521969
Out-patiente Management for Gangrenous Acute Appendicitis: The PENDI-CSI II Randomized Clinical Trial.
A study testing outpatient surgery and Hospitalization in people with Appendicitis Acute and Gangrenous Appendicitis, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Appendicitis Acute, Gangrenous Appendicitis
- What is being tested?
- outpatient surgery and Hospitalization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2025to 1 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- - 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Virgen del Rocío
Seville, Sevilla, 41013
Ainhoa Aixa Maestu Fonseca, +34 639700906, ainhoa.maestu@gmail.com
About this study
Official title: Safety, Efficacy, and Cost-effectiveness of Outpatient Surgery for Gangrenous Acute Appendicitis: The PENDI-CSI II Randomized Clinical Trial.
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.
- Conditions
- Appendicitis Acute, Gangrenous Appendicitis
- Being tested
- outpatient surgery, Hospitalization
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
outpatient surgeryOther
outpatient surgery
HospitalizationOther
Hospitalization after surgery
| Study group | Role | What they receive |
|---|---|---|
| Case | Experimental | Out management patient Receives: Other: outpatient surgery |
| Control | Experimental | hospitalised patient Receives: Other: Hospitalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of outpatient management of patient with acute gangrenous appendicitis after laparoscopic appendectomy.
Numer of hospital readmission
Measured: 1 month after surgery
Secondary outcomes (6)
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.
Measured: Immediately postoperatively (before discharge)
Determine the causes of failure of the outpatient regimen in our patients.
Record of the causes of failure of the outpatient system
Measured: 30 days since the intervention
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.
Measured: 30 days since the intervention
Time off work
Time until patients fully return to work
Measured: 30 days since surgery
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).
Measured: 30 days since surgery
Efficiency of outpatient management
Compare the costs of outpatient care versus hospitalization for patients with acute gangrenous appendicitis undergoing laparoscopic surgery (cost-minimization analysis).
Measured: 30 days since surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 Nov 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appendicitis AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07521969
- Sponsor's protocol ID
- PENDI-CSI II
- Acronym
- PENDI-CSI II
- Status last verified
- Apr 2026
- First submitted
- 25 Jun 2025
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Efficacy, and Cost-effectiveness of Outpatient Surgery for Gangrenous Acute Appendicitis: The PENDI-CSI II Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT07521969
- Acronym / sponsor ID
- PENDI-CSI II / PENDI-CSI II
- Conditions
- Appendicitis Acute, Gangrenous Appendicitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | Experimental | Other: outpatient surgeryOut management patient |
| Control | Experimental | Other: Hospitalizationhospitalised patient |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- - 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| outpatient surgeryoutpatient surgery | Other | Case |
| HospitalizationHospitalization after surgery | Other | Control |
Primary outcome
Safety of outpatient management of patient with acute gangrenous appendicitis after laparoscopic appendectomy.
Time frame: 1 month after surgery
Numer of hospital readmission
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing outpatient surgery and Hospitalization in people with Appendicitis Acute and Gangrenous Appendicitis, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of outpatient management of patient with acute gangrenous appendicitis after laparoscopic appendectomy. (time frame: 1 month after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.