Same Day Ambulatory Appendectomy (SAMBA)

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NICE · Jan 18, 2023

Keywords

ClinConnect Summary

The SAMBA trial is studying the possibility of performing appendectomy surgery for uncomplicated appendicitis in an outpatient setting, meaning patients could go home the same day instead of staying in the hospital. This approach aims to improve patient care by reducing hospital stays, which can free up hospital resources and decrease the risk of exposure to infections, especially during times like the COVID-19 pandemic. The trial also hopes to enhance patient satisfaction, as people often have to wait a long time in emergency departments due to a lack of available hospital beds.

To participate in this trial, candidates must be between 15 and 74 years old, have a body mass index (BMI) of 30 or less, and have a confirmed diagnosis of uncomplicated acute appendicitis through imaging tests. Additionally, they should not have any severe health issues and must live close enough to the hospital to return home easily after the procedure. Participants can expect to undergo surgery and then be monitored for a short time before going home, with the support of a family member or friend. This trial is currently recruiting participants and aims to provide a safer, more efficient way to treat appendicitis, ultimately benefiting both patients and the healthcare system.

Gender

ALL

Eligibility criteria

• 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