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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-69
SponsorNiguarda Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • laparoscopic lavage

    Procedure/Surgery

    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.

Treatment groups

1,067 Participants
are divided into 1 treatment group
Group A: R11 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
90 days after surgery

Secondary outcomes

1

Postoperative complication

Any postoperative complication according to Clavien Dindo classification \> 2a

Time frame
90 days

Other outcomes

Sponsors and contacts

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