Status:
RECRUITING
Same Day Ambulatory Appendectomy (SAMBA)
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Appendicitis
Eligibility:
All Genders
15-74 years
Phase:
NA
Brief Summary
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, r...
Eligibility Criteria
Inclusion Criteria:
-
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
- 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 ≤ 18,000G/L AND
- CRP (C reactive protein) ≤ 60mg/L
-
If pain, calmed by level 3 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
Key Trial Info
Start Date :
July 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 17 2028
Estimated Enrollment :
1400 Patients enrolled
Trial Details
Trial ID
NCT05691348
Start Date
July 17 2023
End Date
January 17 2028
Last Update
March 31 2026
Active Locations (33)
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1
Hôpitaux Pédiatriques de Nice CHU - Lenval
Nice, Alpes Maritimes, France, 06200
2
CHU de Nice
Nice, Alpes-Maritimes, France, 06000
3
CHU de Bordeaux
Bordeaux, Aquitaine, France, 33076
4
CH de Troyes
Troyes, Aube, France, 10000