Appendicitis Clinical Trial
— RESIDENT1Official title:
REsiDENT1 (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
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.
Status | Recruiting |
Enrollment | 1067 |
Est. completion date | September 30, 2025 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 69 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | ASST GOM Niguarda | Milano |
Lead Sponsor | Collaborator |
---|---|
Niguarda Hospital |
Italy,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Postoperative complication | Any postoperative complication according to Clavien Dindo classification > 2a | 90 days |
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