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NCT Number: NCT07521969

Out-patiente Management 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.

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Key information

Conditions

Appendicitis Acute Appendicitis Cecal Diseases Digestive System Diseases Gangrenous Appendicitis Gastroenteritis Gastrointestinal Diseases Infections Intestinal Diseases Intraabdominal Infections

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Virgen del Rocío

Seville, Sevilla, 41013, Spain

Location status: Recruiting

Location contact

Ainhoa Aixa Maestu Fonseca

CONTACT

[email protected]

+34 639700906

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

outpatient surgery

Other

outpatient surgery

Hospitalization

Other

Hospitalization after surgery

Primary outcomes

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

    Time frame: 1 month after surgery

    Numer of hospital readmission

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

    Time frame: Immediately postoperatively (before discharge)

    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.

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

    Time frame: 30 days since the intervention

    Record of the causes of failure of the outpatient system

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

    Time frame: 30 days since the intervention

    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.

  4. Time off work

    Time frame: 30 days since surgery

    Time until patients fully return to work

  5. Degree of satisfaction

    Time frame: 30 days since surgery

    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).

  6. Efficiency of outpatient management

    Time frame: 30 days since surgery

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

Sponsors and collaborators

Lead sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Other

Registry information

Official study title

Safety, Efficacy, and Cost-effectiveness of Outpatient Surgery for Gangrenous Acute Appendicitis: The PENDI-CSI II Randomized Clinical Trial.

Acronym: PENDI-CSI II

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 13, 2026
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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