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

N/ARecruitingNCT07521969

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla122 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

122

Conditions

Appendicitis Acute Gangrenous Appendicitis

Interventions

outpatient surgeryOTHER

outpatient surgery

HospitalizationOTHER

Hospitalization after surgery

Eligibility

Sex: ALLMin age: 14 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital Universitario Virgen del Rocío

Seville, Sevilla, Spain

RECRUITING

Outcomes

Primary Outcomes

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

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)

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

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

Time off work

Time until patients fully return to work

Time frame: 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 satisfaction survey.

Time frame: 30 days since surgery

Data from ClinicalTrials.gov

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