Surgery vs Non-Operative Management for Appendicitis
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Yale University
Must not be taking: Antibiotics
Disqualifiers: Pregnancy, Septic shock, Dialysis, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?
The investigators aim to determine if early operative intervention is superior to non-operative management for adult patients with computerized tomography (CT)-proven complicated appendicitis with phlegmon or abscess.
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.
What data supports the effectiveness of the treatment for appendicitis?
Research shows that non-operative management, which includes treatments like antibiotics and drainage, can be effective for certain types of appendicitis, such as when there is an abscess. Studies indicate that this approach can lead to good outcomes, although it may be more costly than immediate surgery.12345
Is surgery or non-surgical treatment for appendicitis safe?
How does surgical treatment for appendicitis differ from non-operative management?
Surgical treatment for appendicitis, known as appendectomy, involves the physical removal of the appendix through surgery, which is a direct and immediate approach to resolving the condition. This differs from non-operative management, which typically involves using antibiotics to treat the inflammation without surgery, potentially avoiding the risks and recovery time associated with surgical procedures.611121314
Eligibility Criteria
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.
See 6 more
Trial Timeline
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
Treatment Details
Interventions
- Drainage or antibiotics (Antibiotics)
- Operative management (Surgery)
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: SurgeryExperimental Treatment1 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 managementActive Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Yale New Haven HospitalNew Haven, CT
Loading ...
Who Is Running the Clinical Trial?
Yale UniversityLead Sponsor
References
Outcome of initially nonoperative treatment for acute simple appendicitis in children. [2019]To compare the outcome of initially nonoperative treatment with immediate appendectomy for simple appendicitis in children.
Prospective evaluation of nonsurgical versus surgical management of appendiceal mass. [2022]Prospective evaluation was undertaken of surgical findings, complications, morbidity, and hospital stay between initial nonsurgical management versus early surgical intervention of an appendicular mass.
How to treat an appendiceal inflammatory mass: operatively or nonoperatively? [2021]While there is consensus on how to treat acute appendicitis, the most suitable treatment for an appendiceal inflammatory mass is still debated. This study compares the outcomes of operative and nonoperative management.
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. [2021]The aim of this study was to compare surgical outcomes and hospitalization costs between immediate surgery and non-operative management followed by interval appendectomy in adults presenting with appendicitis with abscess.
Complicated appendicitis: Immediate operation or trial of nonoperative management? [2019]The optimal treatment for complicated appendicitis remains controversial. We sought to compare clinical outcomes of patients with complicated appendicitis treated with an immediate operation or a trial of nonoperative management.
The contemporary appendectomy for acute uncomplicated appendicitis in adults. [2020]Epidemiologic data related to the surgical management of appendicitis are out of date. As we contemplate the role of nonoperative therapy in uncomplicated appendicitis, a contemporary profile of the risks and benefits of operative appendectomy is needed.
Long-term outcomes of patients with nonsurgically managed uncomplicated appendicitis. [2021]Emerging literature has supported the safety of nonoperative management of uncomplicated appendicitis.
Severe Complications of Laparoscopic and Conventional Appendectomy Reported to the Finnish Patient Insurance Centre. [2018]Appendectomy is considered a safe operation, the related complications being minor. Negative exploration is an accepted procedure to avoid complications of appendicitis. Treatment with antibiotics is under debate as a primary treatment for appendicitis. The aim of this study was to collect and analyze detailed information on complications and morbidity related to appendectomy using the information of the nationwide Patient Insurance Association (PIA) database and to study the incidence of patient claims and compensated injuries related to appendectomy in Finland.
Is early laparoscopic appendectomy feasible in children with acute appendicitis presenting with an appendiceal mass? A prospective study. [2022]The management of an appendiceal mass remains controversial with 2 schools of thought; early surgical intervention vs nonoperative management with or without interval appendectomy. The aim is to determine the role and safety of early laparoscopic appendectomy (LA) in children with acute appendicitis presenting with an appendiceal mass.
Late-presenting appendicitis: a laparoscopic approach to a complicated problem. [2018]Acute appendicitis is the most common abdominal condition necessitating urgent surgical intervention in the United States. The objective of this study was to determine if interval laparoscopic appendectomy after initial nonoperative treatment for late appendicitis presenting as an appendiceal mass is a safe alternative to immediate appendectomy.
Conservative treatment of acute appendicitis. [2023]Acute appendicitis has been considered by surgeons a progressive disease leading to perforation for more than 100 years. In the last decades the theories about this concept gained attention, especially in adults. However, appendectomy for acute appendicitis remains the most common urgent/emergent surgical procedure. At present, accumulating evidences are showing the changing in clinical practice towards the non-operative management of several cases of acute appendicitis either non-complicated or complicated. The present review aims to show the literature results regarding the non-operative management of acute appendicitis in non-complicated and in complicated cases.
The Unintended Consequences of Nonoperative Management of Acute Appendicitis. [2020]Appendicitis has traditionally been treated surgically. Recently, nonoperative management is emerging as a viable alternative to the traditional operative approach. This raises the question of what are the unintended consequences of nonoperative management of appendicitis with respect to cost and patient burden.
Feasibility of nonoperative treatment of acute appendicitis in children: a prospective cohort study. [2023]The management of acute appendicitis is a matter of debate even in contemporary era. Non-operative management is proposed as a valid treatment option for acute appendicitis in children.
Operation versus antibiotics--The "appendicitis conundrum" continues: A meta-analysis. [2022]Acute appendicitis continues to constitute a diagnostic and therapeutic challenge. The aim of this study was to synthesize evidence from randomized controlled trials (RCTs) comparing nonoperative versus surgical management of uncomplicated acute appendicitis in adult patients.