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

NCT05075252 | Recruiting DMC

• 1 other identifier: S_26_05_21_5158
• Study Type: observational
• Target: 1,067
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Appendicitis; Appendectomy

Keywords

laparoscopy; appendicitis; appendectomy; lavage; suction; abscess

Outcome Measures

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

  90 days after surgery

Secondary Outcomes (1)

• Postoperative complication

  90 days

Study Arms (1)

R1

patients affected by acute appendicitis undergoing totally laparoscopic appendectomy

Procedure: laparoscopic lavage

Interventions

laparoscopic lavage PROCEDURE

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.

R1

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients undergoing laparoscopic appendectomy for acute appendicitis

You may qualify if:

• Patients between 18 and 69 years old
• Surgical laparoscopic approach for AA
• Intra-operative and histological diagnosis of AA

You may not qualify if:

• 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

Sponsors & Collaborators

• Niguarda Hospital: lead

Study Sites (1)

ASST GOM Niguarda

Milan, 20162, Italy

RECRUITING

Related Publications (2)

• Cioffi SPB, Altomare M, Spota A, Granieri S, Cimbanassi S, Chiara O. REsiDENT 1 (Re-assessment of Appendicitis Evaluation during laparoscopic appendectomy: Do we End a Non-standardized Treatment approach and habit?): peritoneal irrigation during laparoscopic appendectomy-does the grade of contamination matter? A prospective multicenter resident-based evaluation of a new classification system. World J Emerg Surg. 2019 May 30;14:25. doi: 10.1186/s13017-019-0243-4. eCollection 2019.

  PMID: 31164914 BACKGROUND

• Cioffi SPB, Granieri S, Scaravilli L, Molteni M, Altomare M, Spota A, Virdis F, Bini R, Renzi F, Reitano E, Ragozzino R, Gupta S, Chiara O, Cimbanassi S; Resident-1 Research Group. Surgeons' attitudes during laparoscopic appendectomy: do subjective intraoperative assessments affect the choice of peritoneal irrigation? A spin-off analysis from the REsiDENT-1 multicentre prospective observational trial. Surg Endosc. 2023 Jan;37(1):729-740. doi: 10.1007/s00464-022-09674-0. Epub 2022 Oct 28.

  PMID: 36307601 DERIVED

MeSH Terms

Conditions

Appendicitis; Abscess

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases; Suppuration; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Stefano Pietro Cioffi, MD

CONTACT

+393386032519; stefanopiero.cioffi@ospedaleniguarda.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: October 12, 2021
• Study Start: October 1, 2019
• Primary Completion: June 30, 2024
• Study Completion (Estimated): September 30, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

IT (1)