Same Day Ambulatory Appendectomy (SAMBA)
ConditionAppendicitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-74
SponsorCentre Hospitalier Universitaire de Nice
About this trial
The potential benefit of outpatient care for this common digestive emergency is considerable, both for the patients themselves and for the public health system:
1. 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. 2. Improved patient satisfaction compared to waiting for hours in the emergency department due to lack of hospital beds. 3. Non-inferiority of care in an outpatient unit in terms of quality and safety in day hospitalization. 4. Significant decrease in the overall cost of this pathology as a result of a reduction in the hospital stay.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 15-74 years
BMI ≤ 35 kg/m2
Uncomplicated acute appendicitis confirmed by imaging (ultrasound and/or CT and/or MRI)
Temperature ≤ 38,1°C and > 35,5°C
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Ambulatory appendectomy
Procedure/SurgeryAppendectomy will be performed in outpatient surgery unit. Patient will be discharge from the hospital the same day as surgery
Conventional appendectomy
Procedure/SurgeryAppendectomy 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
Treatment groups
1,400 Participants
are divided into 2 treatment groupsGroup A: Ambulatory pathwayExperimental treatment 1 intervention
Group B: Conventional hospitalisationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
30 days post surgerySecondary outcomes
1
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.
Time frame
30 days post surgery2
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.
Time frame
30 days post surgery3
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.
Time frame
30 days post surgery4
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).
Time frame
up to the 30th day post surgerySponsors and contacts
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Source ClinicalTrials.gov