Actively Recruiting
Led by Niguarda Hospital · Updated on 2026-04-16
1067
Participants Needed
1
Research Sites
169 weeks
Total Duration
Researchers are conducting a prospective observational multicenter trial to study adult patients undergoing laparoscopic appendectomy for acute appendicitis. The study aims to evaluate the impact of laparoscopic lavage during surgery on the risk of developing postoperative intra-abdominal abscesses. It also introduces a classification system to relate the severity of appendicitis and peritoneal contamination to abscess development, considering surgeons' use of lavage versus suction alone. This trial is resident-driven and involves multiple centers, focusing on improving scientific understanding in a real-world setting. The study examines patients treated with a laparoscopic approach for appendicitis, comparing the use of laparoscopic lavage with suction-only techniques during surgery. Patients are categorized into groups based on the grade of appendicitis and level of peritoneal contamination. Data is collected through online forms by surgical residents and compiled centrally for analysis. The study does not involve randomization or experimental treatment but observes current surgical practices and outcomes. Participants will have their clinical and operative data recorded without personal identifiers. The primary outcome is the occurrence of intra-abdominal abscesses within 90 days after surgery. Secondary outcomes include other postoperative complications during the same period. Statistical methods will identify factors related to abscess risk and help develop a scoring system to classify severity grades. The study is expected to enroll over 1000 patients and will monitor participants for three months post-surgery.
CONDITIONS
Re-assessment of Appendicitis Evaluation During Laparoscopic Appendectomy, Peritoneal Irrigation During Laparoscopic Appendectomy Does the Grade of Contamination Matter?
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo a laparoscopic appendectomy during which data on appendicitis severity and peritoneal contamination are recorded.
1 visit (in-person)
Duration - Up to 90 days after surgery
Participants are monitored for postoperative complications, including intra-abdominal abscesses, for up to 90 days after surgery.
Follow-up visits as per routine clinical care
Total: 1 location
1
ASST GOM Niguarda
Milan, Italy, 20162
Actively Recruiting
S
Stefano Pietro Cioffi, MD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Stefano Piero Bernardo Cioffi, Michele Altomare, Andrea Spota...
https://pubmed.ncbi.nlm.nih.gov/31164914Stefano Piero Bernardo Cioffi, Stefano Granieri, Luca Scaravilli...
https://pubmed.ncbi.nlm.nih.gov/36307601