Acute Appendicitis
Conditions
Keywords
Acute uncomplicated appendicitis, Appendectomy, Patient preference, Treatment choice, Regret, Antibiotic therapy
Brief summary
The ALACARTE study evaluates a strategy in which patients with acute uncomplicated appendicitis are given the choice between appendectomy and antibiotic therapy alone. The investigators hypothesize that giving patients the choice of treatment could reduce treatment regret without compromising safety, particularly by not increasing the risk of complicated appendicitis.Treatment regret will be assessed one year after the randomization. A public health benefit is also anticipated through cost reduction, as antibiotic therapy alone is expected to be less costly than surgery.
Detailed description
Appendectomy provides definitive treatment for acute appendicitis. However, antibiotic therapy alone represents an alternative treatment option for patients with acute uncomplicated appendicitis.Patients are centrally randomized in a 1:1 ratio to either the "Patient Preference Treatment" group or the "Systematic Appendectomy" group.In the "Patient Preference Treatment" group, patients receive information through a video, followed by a discussion with the investigator and a reflection period of at least 30 minutes. Patients may then choose between antibiotic therapy alone and appendectomy. Patients who do not make a treatment choice undergo appendectomy.The study is based on the hypothesis that giving patients a choice of treatment could reduce treatment regret without compromising safety, particularly by not increasing the risk of complicated appendicitis.Treatment regret will be assessed one year after the randomization.
Interventions
Participants receive standardized information and are then allowed to choose between antibiotic therapy alone and appendectomy. Patients who do not express a preference undergo appendectomy.
amoxicillin-clavulanate (PO or IV 1 gx3/day for patients \<90 kg or 1 gx4/day for patients ≥90 kg)
PROCEDUREAppendectomy
Appendectomy
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Investigators are blinded to the patients' responses to the self-administered questionnaires
Intervention model description
ALACARTE trial is a prospective multicenter open-label randomized, superiority clinical trial in two parallel arms (1:1 ratio)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Patients aged 18-70 years 2. Diagnosis of uncomplicated AA established by the investigator surgeon that relies on clinico-biological suspicion of acute AA confirm by care radiological tests (US and/or CT and/or MRI) including appendix diameter \>6.0mm. and without: 1. Diffuse peritonitis on clinical exam (i.e., rigid abdomen / four quadrant peritonitis); 2. Radiologic findings of: i. Free air ii. Walled off fluid collection concerning for an abscess iii. Significant amounts of intra-abdominal fluid throughout abdomen (i.e.,more than trace fluid) iv. Extent of inflammation or adjacent organ involvement on radiologic, appendicular plastron on radiologic imaging 3. Surgery expected within 24 hours after diagnosis 4. Patient able to read and understand the language and content of the study documents and agreeing to adhere to the protocol requirements 5. Patient with internet access at home and a valid email address who declares being able to complete an online questionnaire 6. Signature of the written informed consent form by the patient 7. Affiliation to a French health insurance scheme
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Regret about the initial treatment | 12 month after the randomization | The presence of regret about the initial treatment will be evaluated through a specific questionnaire completed online by the patient. The question will be: "You were initially treated for your appendicitis (infection of the appendix) either by surgery with removal of the appendix (appendectomy) or by antibiotic therapy alone without surgery initially. Do you regret the treatment you received? YES - NO." The surgeon will be blinded to the answer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient's symptom persistence or recurrence | at 12 months | Proportion of patients with at least one symptom persistence or recurrence at 12 months : Symptom persistence defined by participants who report the persistence of significant abdominal pain (≥4 with intensity quantified using the numeric pain rating scale from 0 to 10), the persistence of a perceived or measured fever \> 38.0°C, or the persistence of chills. |
| Patient's quality of life at 12 months. | at 12 months | Quality of life assessed by the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L). questionnaire using the French value set for scoring heath states and fulfilled by the participants (Responses are recorded on a 5-point scale: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems, and 5 = extreme problems or unable to perform the activity.) |
| Regret concerning the treatment received | at 12 months | The regret at 12 months assessed by the validated decisional regret scale. This standardized scale allows quantifying treatment regret by a score ranging from 0 for no regret to 100 for maximum regret. |
| Diagnosis of a complicated AA | within 12 months after randomization | Complicated AA is defined by a localized or diffuse peritonitis, abscessed appendicitis, necrotized appendicitis or appendicular plastron as determined by the surgeon through intraoperative findings or through clinical examination and abdominal imaging (CT-scan or MRI or abdominal US) in case of non-surgical management. |
| Positive bacteriological examination of intrabdominal fluid harvested during surgery | during surgery | — |
| Overall 12-months morbidity | 12 months | The occurrence of at least one of the following complication during the 12 months after randomization: site-related infectious complications (defined as incisional infections or organ-space infections \[abscesses\]), percutaneous drainage procedure, surgical intervention (for complication after appendectomy or appendectomy for recurrent appendicitis after antibiotic), ileus requiring the placement of a nasogastric tube, wound hernia, small bowel obstruction requiring emergency consultation or hospitalization, adverse event related to the known side effects of the administered antibiotic therapy. |
| Unscheduled medical encounter | within 12 months after randomization | by at least one of the following events: * Unscheduled consultations or readmissions at hospital related to the AA or to its treatment reported by the participant. * Among patients treated initially by appendectomy: proportion of patient with unscheduled surgical procedures due to delayed complications after appendicitis or appendectomy. * Among patients treated initially by antibiotics only: proportion of occurrence of appendectomy (with or without appendicitis on the surgical specimen) or unscheduled surgical procedure other than appendectomy due to complications related to the AA. * Among patients treated initially by antibiotics only: proportion of recurrence or persistent AA proven by pathological examination of the appendix after appendectomy or by an imaging (CT or ultrasound or MRI) in case of nonsurgical management. |
| Diagnosis of an appendicular tumor | within 12 months after randomization | Presence of an appendicular tumor (benign or malignant) defined by the anatomopathological diagnosis on the operative specimen of appendectomy. |
| Cost per quality-adjusted life year (QALY) gained | at 12 months | Economic evaluation comparing patients who had the option to select their treatment versus patients who underwent systematic appendectomy. Results will be expressed as cost per QALY gained at 12 months. |
| Cost per additional patient without complication | at 12 months | Economic evaluation comparing patients who had the option to select their treatment versus patients who underwent systematic appendectomy. Results will be expressed as cost per additional patient without complication at 12 months. |
Countries
France
Contacts
CONTACTMaxime COLLARD, MD, PhD
CONTACTThibault VORON, MD, PhD
PRINCIPAL_INVESTIGATORMaxime COLLARD
APHP
Outcome results
None listed