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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14+
SponsorFundación Pública Andaluza para la gestión de la Investigación en Sevilla

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

- Uncomplicated appendectomy.

Intra-operative purulent or faecaloid peritonitis

Appendicular abscess or plastron diagnosed by imaging.

Paralytic ileus preventing oral tolerance.

Trial design

Design model

Sequential

Treatments tested in this trial

  • outpatient surgery

    Other intervention

    outpatient surgery

  • Hospitalization

    Other intervention

    Hospitalization after surgery

Treatment groups

122 Participants
are divided into 2 treatment groups
Group A: CaseExperimental treatment 1 intervention
Group B: ControlExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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