Laparoscopic Surgery or Conservative Treatment for Appendiceal Abscess in Adults? A Randomized Controlled Trial.
Panu Mentula, Henna Sammalkorpi, Ari Leppäniemi
https://pubmed.ncbi.nlm.nih.gov/25775072Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID04168866
Operative Versus Non-Operative Management for Appendicitis With Abscess or Phlegmon
Led by Yale University · Updated on 2025-08-29
180
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare early surgery versus non-surgery treatment for adults with complicated appendicitis confirmed by CT scan showing phlegmon or abscess larger than 2 centimeters. The study addresses the ongoing debate about the best approach to manage this condition, as current treatments vary and prior trials outside the United States have suggested benefits of surgery but lack high-quality US data. The goal is to see which approach leads to better outcomes for patients in multiple US centers. Participants who choose surgery will undergo laparoscopic removal of the appendix through small incisions along with draining any abscess present during the same operation. In some cases, open surgery or additional intestinal procedures may be needed. Those opting for non-operative management will receive antibiotics, and if an abscess is present and can be drained, this will be done without surgery. The study allows patients to choose their treatment, and both groups receive standard care appropriate to their assigned approach. During the study, participants will be monitored for hospital stay length, need for further interventions, complications, abscess development, and quality of life related to gastrointestinal health. Evaluations include follow-up for up to one year to track recurrence, delayed surgery, or other outcomes. The study collects data on disability days and any malignancy found in removed tissue. Safety measures and treatment success are carefully assessed over time to understand the best management for complicated appendicitis.
CONDITIONS
Brief Title
Operative Versus Non-Operative Management for Appendicitis With Abscess or Phlegmon
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Complicated appendicitis with presumed perforation on CT scan
- Presence of phlegmon or abscess larger than 2 centimeters
You will not qualify if you...
- Antibiotic therapy longer than 24 hours before enrollment consideration
- Attempted drainage before randomization
- Pregnancy
- Allergy to beta-lactam or quinolone antibiotics requiring alternative therapy
- Previous major intra-abdominal surgery by laparotomy
- Hospitalization within 2 weeks before randomization
- Presence of septic shock on admission
- Mechanical ventilation
- Acute renal failure requiring dialysis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Hospital stay plus immediate recovery period
Participants who choose surgery will have their appendix removed laparoscopically or through an open procedure, with abscess drainage if needed, and receive standard perioperative antibiotics.
Hospital stay followed by several post-operative visits
Implementation
Duration - Until resolution of abscess or infection
Participants who choose non-operative management may receive percutaneous drainage of abscesses if applicable or antibiotics alone.
1 to 2 visits depending on treatment response
Post-operative Follow-up
Duration - Up to 1 year after initial treatment
Participants are monitored for complications, recurrence, and quality of life after intervention.
Follow-up visits up to 1 year post-treatment
Trial Site Locations
Total: 1 location
1
Yale New Haven Hospital
New Haven, Connecticut, United States, 06512
Actively Recruiting
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Research Team
K
Kevin Schuster, MD, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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