Surgery vs Non-Operative Management for Appendicitis

Overseen By Kevin Schuster, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Must not be taking: Antibiotics

Disqualifiers: Pregnancy, Septic shock, Dialysis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 60 days

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether surgery or non-surgical treatments are more effective for adults with complicated appendicitis, particularly when a CT scan reveals a tear and either a swollen mass or an abscess larger than 2 cm. Participants in the surgery group will have their appendix removed through small incisions, and any abscesses will be drained. Those in the non-surgical group will receive antibiotics, and if an abscess can be drained without surgery, percutaneous drainage will be performed. Suitable candidates for this trial have a CT scan showing complicated appendicitis with a large mass or abscess and have not taken antibiotics for more than 24 hours. As an unphased trial, this study offers participants the chance to contribute to important research that may enhance treatment options for complicated appendicitis.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on antibiotics for more than 24 hours before enrollment, you cannot participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that an appendectomy, the removal of the appendix, is generally safe. The risk of death from this surgery is very low, ranging from 0.09% to 0.24%. It serves as the main treatment for appendicitis, and most patients recover well afterward.

For those considering non-surgical options, such as draining an abscess or using antibiotics, studies suggest these are also safe. One study found that treating complicated appendicitis this way succeeds more than 80% of the time. Percutaneous drainage, which involves using a needle to remove fluid, is noted for being both effective and safe.

Both treatment options offer safety benefits, so discussing with medical professionals is important to choose the best option for individual needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it compares two different approaches for managing appendicitis: surgery and non-operative management. Traditionally, appendicitis is treated with surgery to remove the appendix, often through a minimally invasive laparoscopic procedure. However, this trial explores the potential of managing appendicitis without surgery by using antibiotics, and possibly drainage if an abscess is present. This non-operative approach could offer a less invasive option with a quicker recovery time, avoiding the risks and recovery associated with surgery. The trial aims to determine if non-operative management can be as effective as surgery, potentially changing the standard approach to treating appendicitis.

What evidence suggests that this trial's treatments could be effective for appendicitis?

This trial will compare surgery with non-operative management for appendicitis. Research has shown that an appendectomy, the surgical removal of the appendix, is a safe and effective treatment for appendicitis. Studies have found that laparoscopic surgery, which uses small cuts and a camera, allows for quicker recovery and shorter hospital stays compared to open surgery. The risk of death from an appendectomy is very low, between 0.09% and 0.24%, making it a reliable option for treating appendicitis.

Alternatively, participants in the non-operative management arm will receive treatment involving antibiotics and sometimes draining fluid from an abscess. Research indicates that this method has a lower chance of appendicitis recurrence and often avoids the need for additional surgery. Both treatments have shown good results, and the choice may depend on individual situations and preferences. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

Adults with a specific type of appendicitis shown on CT scans, which includes a perforation and an abscess or phlegmon over 2 cm. Not eligible if they've had major abdominal surgery, recent hospitalization, septic shock at admission, need mechanical ventilation or dialysis, are pregnant, have had certain treatments prior to the trial or have specific antibiotic allergies.

Inclusion Criteria

My appendicitis is severe with a rupture and infection shown on a CT scan.

Exclusion Criteria

Antibiotic therapy greater than 24 hours prior to considering for enrollment.

I have tried draining fluid before being assigned to a treatment group.

I am allergic to common antibiotics and need alternative treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants choose between operative and non-operative management for appendicitis with abscess or phlegmon

60 days

Follow-up

Participants are monitored for safety, effectiveness, and quality of life after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Drainage or antibiotics
• Operative management

Trial Overview

The study is comparing two approaches for treating complicated appendicitis: one group will undergo surgery while the other will receive non-surgical treatment with drainage or antibiotics. The goal is to see which method is more effective.

How Is the Trial Designed?

Group I: Surgery Experimental Treatment 1 Intervention

Patients who choose operations will have surgery performed to remove the appendix laparoscopically, through 3 or 4 small incisions. All patients in the operative group will receive standard perioperative antibiotics. They will also have the abscess(es) drained during the same surgery if there is one present. In some cases, the operation may be too difficult to perform laparoscopically, so an open appendectomy will be performed, involving a longer incision to remove the appendix. In some cases, both laparoscopic and open are performed. The surgeon may also choose to remove a section of the intestine with the appendix or perform additional procedures.

Group II: Non-operative management Active Control 1 Intervention

If a patient chooses non-operative management and if an abscess is present and amenable to percutaneous drainage this will be performed. If there is no abscess or it is not amenable to drainage antibiotics alone will be provided.

Operative management is already approved in United States, European Union for the following indications:

Approved in United States as Surgical intervention for:

• Acute uncomplicated appendicitis
• Complicated appendicitis with abscess or phlegmon

Approved in European Union as Surgical intervention for:

• Acute uncomplicated appendicitis
• Complicated appendicitis with abscess or phlegmon

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Published Research Related to This Trial

In a study of 190 children with suspected acute appendicitis, a non-operative management approach led to symptom resolution in 87.3% of patients, highlighting its efficacy as a treatment option for uncomplicated cases.

Factors such as shorter symptom duration (≤ 24 hours), lower white blood cell count (<12 × 10^9 cells/L), and smaller appendix size on ultrasound were associated with higher success rates for non-operative treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of nonoperative treatment of acute appendicitis in children: a prospective cohort study. Perveen, S., Akhtar, J., Ali, S., et al.[2023]

Non-operative management followed by interval appendectomy was successful in 76.6% of cases, leading to lower postoperative morbidity and reduced need for extended resection compared to immediate surgery.

While the initial surgical costs were lower for the interval strategy ($4512 vs $6888), the total medical costs were higher due to longer overall treatment ($9591 vs $6888), indicating a trade-off between immediate costs and comprehensive care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Superior outcomes (but at higher costs) of non-operative management with interval appendectomy over immediate surgery in appendicitis with abscess: Results from a large adult population cohort. Watanabe, R., Otsuji, A., Nakamura, Y., et al.[2021]

Nonoperative management of appendicitis is becoming more common, increasing from 3.6% in 2010 to 6.8% in 2014, but patients treated this way have a higher risk of readmission within 6 months compared to those who undergo surgery, with a 59% decreased odds of readmission for surgical patients.

Despite the higher risk of readmission, nonoperative management results in lower overall costs, with an adjusted cost increase of $2900 associated with surgical treatment, highlighting the need for careful patient assessment when considering treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Unintended Consequences of Nonoperative Management of Acute Appendicitis. Oliveira, K., Jean, RA., Gonsai, R., et al.[2020]

In a review of five randomized controlled trials involving 1,430 adult patients, nonoperative treatment with antibiotics for uncomplicated acute appendicitis showed a significantly lower treatment efficacy (63.8%) compared to surgical management (93%).

However, the surgery group experienced a higher rate of complications (23.6%) compared to the antibiotics group (7.7%), suggesting that while surgery is more effective, it also carries greater risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Operation versus antibiotics--The "appendicitis conundrum" continues: A meta-analysis. Sakran, JV., Mylonas, KS., Gryparis, A., et al.[2022]

In a study of 32 patients with appendiceal masses, those who received initial nonoperative treatment followed by interval laparoscopic appendectomy showed significant improvement and a quicker return to normal activities compared to those who underwent immediate surgery.

The safety and complication rates were comparable between the two groups, suggesting that interval laparoscopic appendectomy is a viable and effective alternative to immediate appendectomy for treating late appendicitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Late-presenting appendicitis: a laparoscopic approach to a complicated problem. Gibeily, GJ., Ross, MN., Manning, DB., et al.[2018]

In a study involving children aged 7-17 with simple appendicitis, initially nonoperative treatment was found to have similar outcomes to immediate appendectomy, with complication rates of 12% and 11% respectively.

The nonoperative approach allowed 3 out of 4 children to avoid surgery altogether, and those who did require an appendectomy did not experience any complications post-surgery, indicating a safe and effective alternative treatment strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome of initially nonoperative treatment for acute simple appendicitis in children. Gorter, RR., van der Lee, JH., Heijsters, FACJ., et al.[2019]

Recent evidence suggests a shift in clinical practice towards non-operative management of acute appendicitis, both in non-complicated and complicated cases, challenging the long-held belief that surgery is always necessary.

Despite appendectomy being the most common urgent surgical procedure for appendicitis, there is growing support for treating certain cases without surgery, indicating a potential change in how this condition is managed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conservative treatment of acute appendicitis. Coccolini, F., Fugazzola, P., Sartelli, M., et al.[2023]

Complications from appendectomy are rare, occurring in only 0.2% of cases, indicating that the procedure is generally safe.

However, laparoscopic appendectomy was associated with a higher rate of severe complications compared to open surgery, leading to more cases requiring additional surgery or resulting in organ failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Severe Complications of Laparoscopic and Conventional Appendectomy Reported to the Finnish Patient Insurance Centre. Kotaluoto, S., Pauniaho, SL., Helminen, MT., et al.[2018]

Early laparoscopic appendectomy (LA) for children with an appendiceal mass can be performed safely, with no perioperative or postoperative mortalities and minimal morbidity, indicating its safety as a treatment option.

While early LA for appendiceal mass resulted in longer operating times and recovery metrics compared to simple appendicitis, it is still a viable option that can prevent misdiagnoses and the need for additional hospital visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is early laparoscopic appendectomy feasible in children with acute appendicitis presenting with an appendiceal mass? A prospective study. Goh, BK., Chui, CH., Yap, TL., et al.[2022]

In a study of 82 children with appendicular masses, early surgical intervention (appendectomy at presentation) resulted in a significantly shorter hospital stay (4.8 days) compared to nonsurgical management followed by interval appendectomy (13.2 days).

Patients who underwent early surgery had a lower rate of complications, such as superficial wound infections (0% in the surgical group vs. 8% in the nonsurgical group), highlighting the safety and efficacy of early surgical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective evaluation of nonsurgical versus surgical management of appendiceal mass. Samuel, M., Hosie, G., Holmes, K.[2022]

In a study of 119 patients with appendiceal inflammatory mass, nonoperative management led to a high recurrence rate of 71%, with over half requiring further surgical or radiological intervention, highlighting its limitations.

In contrast, patients who underwent surgery had no recurrences and a complication rate of 17.6%, suggesting that operative management is more effective and safer for treating appendiceal inflammatory masses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to treat an appendiceal inflammatory mass: operatively or nonoperatively? Deelder, JD., Richir, MC., Schoorl, T., et al.[2021]

In a study of 101 adult patients with complicated appendicitis, nonoperative management was successful in 86.1% of cases, indicating it can be an effective initial treatment option.

Patients who failed nonoperative management experienced significantly longer hospital stays (11 days) compared to those who underwent immediate surgery (5 days), highlighting the potential risks of delaying surgical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complicated appendicitis: Immediate operation or trial of nonoperative management? Nimmagadda, N., Matsushima, K., Piccinini, A., et al.[2019]

A study analyzing 7,778 adult appendectomies found that preoperative imaging is standard practice, with 96.1% of patients receiving imaging, primarily CT scans, leading to a low negative appendectomy rate of 3.8%.

The majority of appendectomies were performed laparoscopically (97.4%), resulting in high rates of same-day discharge (87.3%) and very low 30-day mortality (0.04%) and complication rates (3.0% for any complications).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The contemporary appendectomy for acute uncomplicated appendicitis in adults. Childers, CP., Dworsky, JQ., Maggard-Gibbons, M., et al.[2020]

In a study of 231,678 patients with uncomplicated appendicitis, nonoperative management was found to be safe, with only 5.9% experiencing treatment failure and 4.4% recurrence over a median follow-up of more than 7 years.

There were no deaths linked to treatment failure or recurrence, and the risk of perforation after discharge was about 3%, suggesting that nonoperative management can be a viable alternative to surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcomes of patients with nonsurgically managed uncomplicated appendicitis. McCutcheon, BA., Chang, DC., Marcus, LP., et al.[2021]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/17103286/

Comparison of therapeutic effectiveness of percutaneous ...

Conclusions: Percutaneous drainage with antibiotics is a safe and effective way of treating acute perforated appendicitis. The recurrence rate for these ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11656506/

A Systematic Review and Meta-Analysis - PMC

On the other hand, patients in the antibiotics plus percutaneous drainage group had lower rates of recurrence and required fewer interval appendectomies. More ...

3.

ajronline.org

ajronline.org/doi/10.2214/AJR.09.3098

Percutaneous Abscess Drainage in Patients With ...

Our results show that percutaneous drainage is effective and safe in the treatment of patients with acute appendicitis complicated by perforation and abscess.

4.

cureus.com

cureus.com/articles/314378-efficacy-of-antibiotic-therapy-alone-versus-antibiotics-with-percutaneous-drainage-in-periappendiceal-abscess-a-systematic-review-and-meta-analysis.pdf

Efficacy of Antibiotic Therapy Alone Versus ...

Comparing the efficacy of antibiotics-only therapy to antibiotics plus percutaneous drainage, we found that antibiotics had more odds ratio of ...

5.

bmcsurg.biomedcentral.com

bmcsurg.biomedcentral.com/articles/10.1186/s12893-016-0188-4

Therapeutic effectiveness of percutaneous drainage and ...

We found that patients treated with percutaneous drainage and antibiotics had a significantly lower rate of recurrent appendicitis (p < 0.05), ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12537128/

Clinical study on the safety of omitting abdominal drainage ...

Retrospective analyses suggest that drainage offers no advantage in complicated appendicitis. For instance, drainage in pediatric perforated ...

7.

coloproctol.org

coloproctol.org/journal/view.php?viewtype=pubreader&number=2023

Clinical outcomes and optimal indications for nonoperative ...

Complicated appendicitis with localized abscess or phlegmon could also be treated conservatively, with a success rate of more than 80%. An ...

8.

pdfs.semanticscholar.org

pdfs.semanticscholar.org/d119/2a8c9f0e863481494acf16ad4aba7fc8f9dd.pdf

Outcomes of Percutaneous Drainage vs. Antibiotic Therapy ...

Similar to our study, the risk of recurrent appendicitis was very low as 1 out of 44 patients. (2.3%) in the percutaneous drainage group and 3 out of 57 (5.3%) ...