About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Patients between 18 and 69 years old
Surgical laparoscopic approach for AA
Intra-operative and histological diagnosis of AA
Disqualifiers
Patients < 18 years old or > 69 years old
Previous appendectomy
Previous appendicitis treated conservatively
Open approach for surgery or intra-operative conversion
Trial population
Adult patients undergoing laparoscopic appendectomy for acute appendicitis
Trial design
Cohort
Prospective
Treatments tested in this trial
laparoscopic lavage
Procedure/SurgeryThis 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.
Treatment groups
Trial outcomes
Primary outcomes
Postoperative Intrabdominal Abscess
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
Secondary outcomes
Postoperative complication
Any postoperative complication according to Clavien Dindo classification \> 2a
Sponsors and contacts
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