Evaluating the impact of peritoneal irrigation during laparoscopic appendectomy for appendicitis
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
This study is testing if washing out the abdomen during laparoscopic surgery for appendicitis can help prevent infections in adults with this condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1067 (estimated) |
| Ages | 18 Years to 69 Years |
| Sex | All |
| Sponsor | Niguarda Hospital Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT05075252 on ClinicalTrials.gov |
What this trial studies
This prospective observational multicenter trial aims to assess the effects of laparoscopic lavage during laparoscopic appendectomy on the incidence of postoperative intra-abdominal abscesses in adult patients with acute appendicitis. The study will categorize patients based on the grade of contamination and severity of appendicitis to determine if the use of irrigation offers any advantages over suction alone. By introducing a classification system for different degrees of appendicitis and contamination, the study seeks to clarify the relationship between surgical techniques and postoperative outcomes. Data will be collected preoperatively, intra-operatively, and postoperatively to identify predictive factors for infectious complications.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 69 who are undergoing laparoscopic appendectomy for acute appendicitis.
Not a fit: Patients outside the age range of 18 to 69, those with previous appendectomies, or those with other intra-abdominal infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical protocols that reduce the risk of postoperative complications for patients undergoing laparoscopic appendectomy.
How similar studies have performed: While there are few randomized controlled trials on this topic, existing studies have shown mixed results, indicating that this approach may be novel and requires further investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Milan
- ASST GOM Niguarda — Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Stefano Pietro Cioffi, MD
- Email: stefanopiero.cioffi@ospedaleniguarda.it
- Phone: +393386032519
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.