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/25775072/Actively Recruiting
Led by Yale University · Updated on 2025-08-29
180
Participants Needed
1
Research Sites
52 weeks
Total Duration
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
Operative Versus Non-Operative Management for Appendicitis With Abscess or Phlegmon
K
Kevin Schuster, MD, MPH
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Yale University
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Surgery for Complicated Appendicitis | Drainage and/or Antibiotics |
|---|---|---|
| What it is | Immediate or early appendectomy to remove the inflamed appendix in cases where a CT scan shows an abscess or phlegmon larger than 2 cm. | Management without immediate surgery. If the abscess can be drained through the skin, this is performed; if not, antibiotics are given alone. |
| Primary use | Remove the appendix during the initial admission to treat infection and resolve inflammation. | Control infection and inflammation through antibiotics and drainage, with surgery delayed or avoided unless necessary. |
| How it is given or performed | Surgical procedure (appendectomy), typically via open or laparoscopic approach, scheduled soon after diagnosis. | Image-guided percutaneous drainage if possible; otherwise intravenous antibiotics with close monitoring. Surgery is reserved for patients who do not improve. |
| Evidence status | Ongoing trial evidence for comparative outcomes. Prior studies have found immediate surgery is effective, with a risk of increased complications compared to non-operative management. | Ongoing trial evidence for comparative outcomes. Published studies indicate non-operative management can be successful, with fewer immediate complications, though some patients later require surgery. |
| Important risks | Surgical treatment may increase the likelihood of short-term complications, such as wound infection or intra-abdominal abscess. | Possible risks include failure to resolve infection, recurrence, or late need for surgery, but immediate postoperative complications are less frequent. |
| Important limitations | Surgery may cause more complications in severely inflamed tissue. Hospital stays and recovery may be longer compared to some cases managed non-operatively. | Not all patients respond to non-operative treatment. About 1 in 5 may require surgery later, and close follow-up is needed to monitor for recurrence or unresolved infection. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Panu Mentula, Henna Sammalkorpi, Ari Leppäniemi
https://pubmed.ncbi.nlm.nih.gov/25775072/Yale University
Lead Sponsor