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

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.

Study Overview

• Status: Recruiting
• Conditions: Appendicitis Acute; Gangrenous Appendicitis
• Intervention / Treatment: Other: outpatient surgery; Other: Hospitalization

• Study Type: Interventional
• Enrollment (Estimated): 122
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Sevilla
    • Seville, Sevilla, Spain, 41013
      • Recruiting
      • Hospital Universitario Virgen del Rocio
      • Contact: Ainhoa Aixa Maestu Fonseca; Phone Number: +34 639700906; Email: ainhoa.maestu@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Case; Out management patient	Other: outpatient surgery; outpatient surgery
Experimental: Control; hospitalised patient	Other: Hospitalization; Hospitalization after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of outpatient management of patient with acute gangrenous appendicitis after laparoscopic appendectomy.	Numer of hospital readmission	1 month after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	30 days since the intervention
Time off work	Time until patients fully return to work	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).	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).	30 days since surgery

Collaborators and Investigators

• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: June 25, 2025
• First Submitted That Met QC Criteria: April 2, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Infections; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Cecal Diseases; Intraabdominal Infections; Appendicitis; Therapeutics; Surgical Procedures, Operative; Patient Care; Health Services; Health Care Facilities Workforce and Services; Hospitalization; Ambulatory Surgical Procedures
• Other Study ID Numbers: PENDI-CSI II

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No