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Clinical Trials in Italy / NCT05075252
Recruiting Observational

Re-assessment of Appendicitis Evaluation During Laparoscopic Appendectomy, Peritoneal Irrigation During Laparoscopic Appendectomy Does the Grade of Contamination Matter?

NCT05075252 · tracked via the Priya Life Science Italy tracker
Sponsor
Niguarda Hospital
Phase
Observational
Started
2019-10-01
Last updated
2026-04-16

Condition(s) studied

AppendicitisAppendectomy

Investigational drug(s) / intervention(s)

laparoscopic lavage

laparoscopic lavage: This study aims to investigate the impact of laparoscopic lavage on the incidence of postoperative abscesses stratifying patients on the grade of appendicitis and peritoneal contamination.

Study summary

Type: prospective observational multicenter trial. Population of interest: adult patients undergoing laparoscopic appendectomy for acute appendicitis.

Hypothesis : laparoscopic lavage during laparoscopic appendectomy is a practice that should be used in selected patients according to the intraperitoneal grade of contamination and grade of appendicitis. Nonregulated use of laparoscopic lavage cannot be considered superior to suction only considering recent evidence. Few RCT available addressing this issue are available, but any with a high methodological quality.

Aim: The aim of this study is to investigate the impact of laparoscopic lavage during laparoscopic appendectomy on the postoperative incidence of intrabdominal abscesses, stratifying patients in different clusters according to a defined classification considering the intraperitoneal contamination and grade of appendicitis.

Eligibility

Sex
ALL
Min age
18 Years
Max age
69 Years
Healthy volunteers
No
Inclusion Criteria: * Patients between 18 and 69 years old * Surgical laparoscopic approach for AA * Intra-operative and histological diagnosis of AA Exclusion Criteria: * Patients \< 18 years old or \> 69 years old * Previous appendectomy * Previous appendicitis treated conservatively * Open approach for surgery or intra-operative conversion * Co-existence of other intra-abdominal infections (IAI) * Patients with immunodeficiency * Patients treated with steroid, immunosuppressant, or CHT within previous 6 months

Primary outcome measure(s)

  • Postoperative Intrabdominal Abscess — 90 days after surgery
    Surgical site infections are divided into three categories: superficial incisional SSI,deep incisional SSI and organ/space surgical site infection.O/S SSI must meet the following criteria;date of event within 30 days after surgical procedure,involvement of any part of the body deeper than the fascial/muscle layers that are opened or manipulated during the operative procedure.At least one of the following:purulent drainage from a drain that is placed into the organ/space (eg;closed suction drainage system,open drain,T-tube drain,CT-guided drainage).Organism(s) identified from fluid or tissue in the organ/space by a culture- or non-culture-based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment.An abscess or other evidence of infection involving the organ/space that is detected on the gross anatomical or histopathologic exam,or imaging test evidence suggestive of infection

Trial sites (1)

FacilityCityRegionStatus
ASST GOM Niguarda Milan Italy Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05075252 on ClinicalTrials.gov ↗ ← All trials in Italy