Same Day Ambulatory Appendectomy (SAMBA)

Study Overview
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Brief Summary
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The potential benefit of outpatient care for this common digestive emergency is considerable, both for the patients themselves and for the public health system: Optimization of the care pathway, reducing the length of stay in hospital (a major issue in the context of the COVID-19 (coronavirus disease) pandemic) liberating patient beds and staff, and reducing the risk of nosocomial exposure. Improved patient satisfaction compared to waiting for hours in the emergency department due to lack of hospital beds. Non-inferiority of care in an outpatient unit in terms of quality and safety in day hospitalization. Significant decrease in the overall cost of this pathology as a result of a reduction in the hospital stay.

Official Title
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Same Day Ambulatory Appendectomy (SAMBA)

Conditions
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Appendicitis

Intervention / Treatment
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* Procedure: Ambulatory appendectomy
* Procedure: Conventional appendectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 15-74 years BMI ≤ 30 kg/m2 Uncomplicated acute appendicitis confirmed by imaging (ultrasound and/or CT and/or MRI) Temperature ≤ 38,1°C and > 35,5°C Appendix diameter > 6mm and ≤ 15mm Without effusion or with only localized peri-appendicular effusion Infiltration of peri-appendicular fat without abscess or plastron No sign of perforation Leukocytes ≤ 15,000G/L AND CRP (C reactive protein) ≤ 50mg/L If pain, calmed by level 2 analgesic at maximum Ambulatory criteria Availability of monitoring by a relative during the 12 hours after discharge from the hospital Residence located less than 20 minutes by car from a health center (hospital or clinic) Access to a telephone mobile or fixed in case of problems Signature of the written informed consent form by the patient If the patient is a minor, signature of the written informed consent form by both parents or their legal representative Affiliation to a French health insurance scheme or equivalent Exclusion Criteria: Criteria that exclude ambulatory care such as an ASA score (Physical status score) > 2, severe or uncontrolled comorbidities, severe pulmonary disease including obstructive sleep apnea, anticoagulation or antiplatelet drug or contraindication to ambulatory surgery such as intubation difficulties Presence of active cancer, a malignant hemopathy, drug addiction, coagulopathy, immunosuppressive treatment Non-acute or interval appendectomy, i.e. after antibiotic treatment of a complicated appendicitis of the plastron or drainage of an appendicular abscess; History of pelvic surgery Vulnerable people: pregnant or breast-feeding women (patients will undergo a pregnancy test: plasmatic β-hCG (human chorionic gonadotropin) or urinary test), adult under guardianship or deprived of freedom. Pregnant women are considered to have a full stomach, with risk of inhalation at anesthetic induction and represent a contraindication to ambulatory surgery. In addition, the need to perform abdominal surgery on a pregnant woman requires obstetric monitoring that is difficult to reconcile with management in an outpatient surgery unit (need for obstetric ultrasound or monitoring). Suspicion of a tumor of the appendix : Mucocele and pseudomyxoma, Carcinoid tumor, Adenocarcinoma of the appendix, Another type of tumor

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ambulatory pathway<br> | Procedure: Ambulatory appendectomy<br>* Appendectomy will be performed in outpatient surgery unit. Patient will be discharge from the hospital the same day as surgery<br>|
| Active Comparator: Conventional hospitalisation<br> | Procedure: Conventional appendectomy<br>* Appendectomy will be performed in digestive surgery department. Patient will be discharge from the hospital the day after surgery: he will spend a night under observation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate that outpatient care, compared with conventional care, in selected patients with acute uncomplicated appendicitis operated by laparoscopy, is non-inferior in terms of overall morbi-mortality on the 30th postoperative day. | Morbi-mortality will be assessed by classifying post-operative complications according to Clavien-Dindo classification. It will be compared between both groups (ambulatory pathway versus conventional hospitalization CONV) on the 30th postoperative day. The Clavien-Dindo classification was originally published in 2004 in the Annals of Surgery for elective general surgery. Later, it has been objectively validated for all surgical specialties. This classification ranks complications from 0 (no complication) to 5 (death). Complications that potentially lead to long-lasting disability after discharge (e.g.: paralysis of a vocal cord after thyroid surgery) are highlighted in the present classification by a suffix (d for disability). This suffix indicates that a long-term follow-up is required to comprehensively evaluate the outcome and related long-term quality of life. | 30 days post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare between both groups, at post-operative day 30, the delay from diagnosis to appendectomy | The delay from diagnosis to appendectomy is defined as the time between the performance of the CT scan (or ultrasound or MRI) for diagnosis and the skin incision in the operating room. This time is expressed in minutes. | 30 days post surgery | 
| To compare between both groups, at post-operative day 30, the real cumulated length of hospitalization | The real cumulated length of hospitalization is the cumulative length of the entire hospital stay(s) in hours until the 30th postoperative day (rehospitalizations included). The length of stay in a non-hospital health structure, such as a convalescent center, will not be included. | 30 days post surgery | 
| To compare between both groups, at post-operative day 30, the rehospitalization rate | All re-hospitalization(s) after initial discharge will be counted until 30 days post surgery, whatever the cause or type of hospitalization. | 30 days post surgery | 
| To compare between both groups, the mild morbidity (Clavien-Dindo I-II) during 30 days post surgery | Post-operative mild morbidity will be assessed with the Clavien-Dindo classification (grade I, II) up to the 30th day post surgery. Clavien-Dindo classification was originally published in 2004 in the Annals of Surgery for elective general surgery. Later, it has been objectively validated for all surgical specialties. This classification ranks complications from 0 (no complication) to 5 (death). | up to the 30th day post surgery | 
| To compare between both groups, the severe morbidity (Clavien-Dindo III, IV, V) during 30 days post surgery | Post-operative mild morbidity will be assessed with the severe morbidity (Clavien-Dindo III, IV, V) up to the 30th day post surgery. Clavien-Dindo classification was originally published in 2004 in the Annals of Surgery for elective general surgery. Later, it has been objectively validated for all surgical specialties. This classification ranks complications from 0 (no complication) to 5 (death). | up to the 30th day post surgery | 
| To compare between both groups, the rate of interventional radiology re-intervention (radio-guided drainage) | All the Clavien-Dindo interventional radiology re-interventions (radio-guided drainage) performed in relation with the appendicitis and any potential complications will be recorded up to the 30th day post surgery. | up to the 30th day post surgery | 
| To compare between both groups, the rate of laparoscopic re-intervention | All laparoscopic re-interventions performed in relation with the appendectomy and the potential complications will be recorded up to the 30th day post surgery. | up to the 30th day post surgery | 
| To compare between both groups, at post-operative day 30, the rate of re-intervention by laparotomy | All the laparotomic re-interventions performed in relation with the appendectomy and the potential complications will be recorded up to the 30th day post surgery. | up to the 30th day post surgery | 
| To compare between both groups, patient satisfaction 7 and 30 days post surgery | Patient satisfaction will be assessed using a numerical scale from 0 to 10, using the Link4Life app. Zero '0', placed on the left, means that the patient is not satisfied at all with her/his postoperative course; '10', placed on the right, means that the patient is extremely satisfied with her/his postoperative course. If the patient does not have access or does not wish to access Link4Life, a clinical research assistant from the investigating center will collect the patient's satisfaction through a phone call. The questions that will be asked are: How satisfied are you with your care?; are you in pain and if so, how severe is it?; Were you worried about same-day discharge (for patients in the outpatient group)? | 7 and 30 days post surgery | 
| To compare between both groups, patient quality of life 7 and 30 days post surgery | Quality of life will be evaluated using the EuroQol five-dimension questionnaire (EQ-5D-5L), at inclusion, and at 7 and 30 days post surgery.The EQ-5D-5L comprises a descriptive system and a visual analogue scale (VAS). The descriptive system is composed of five health dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) with 5 levels of health (no problems, slight problems, moderate problems, severe problems and extreme problems). For each of the 5 dimensions, the participant's answer is converted to a number between 1 and 5, expressing the health state reported. The responses are combined to produce a five-digit number describing the participant's health status which is converted to a utility value from the country specific value set. The French EQ-5D-5L value set has utility between -0.530 (health condition worse than death) and 1 (best possible health). The VAS records the self-rated health status on a graduated scale from 0 to 100. | at inclusion and at 7 and 30 days post surgery | 
| To evaluate the rate of conversion from outpatient to conventional care | A conversion will be defined as a patient randomized to the outpatient care group who is finally treated following the conventional care procedure, whatever the reason | up to the 30th day post surgery | 
| To estimate the cost of outpatient appendectomy management | The cost will be estimated by the hospital cost (intervention and outpatient stay). | up to the 30th day post surgery | 
| To study the economic impact (utility) of outpatient appendectomy management compared to conventional hospitalization | The economic impact will be studied with a cost-utility analysis which will estimate the incremental cost-effectiveness ratio (ICER) in cost per QALY (quality adjusted life years) gained. | up to the 30th day post surgery | 
| To study the economic impact (effectiveness) of outpatient appendectomy management compared to conventional hospitalization | The economic impact will be studied with a cost-effectiveness analysis which will estimate the ICER in cost per patient without rehospitalization. | up to the 30th day post surgery | 
| To study the generalization of outpatient appendectomy management in all French hospitals at the budgetary level | The generalization of outpatient appendectomy management will be studied with a budget impact model which will estimate the consequences in terms of costs | up to the 30th day post surgery | 
| To study the generalization of outpatient appendectomy management in all French hospitals at a strategic level | The generalization of outpatient appendectomy management will be studied with QALYs (quality adjusted life years) of the adoption of the outpatient strategy in all French hospitals | up to the 30th day post surgery |