Same Day Ambulatory Appendectomy (SAMBA)

Обзор

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.

Вмешательства

• Процедура Ambulatory appendectomy
  Appendectomy will be performed in outpatient surgery unit. Patient will be discharge from the hospital the same day as surgery
• Процедура Conventional appendectomy
  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

Первичные конечные точки

• 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. [Срок оценки: 30 days post surgery]

Вторичные конечные точки (12)

• To compare between both groups, at post-operative day 30, the delay from diagnosis to appendectomy [Срок оценки: 30 days post surgery]
• To compare between both groups, at post-operative day 30, the real cumulated length of hospitalization [Срок оценки: 30 days post surgery]
• To compare between both groups, at post-operative day 30, the rehospitalization rate [Срок оценки: 30 days post surgery]
• To compare between both groups, the mild morbidity (Clavien-Dindo I-II) during 30 days post surgery [Срок оценки: 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 [Срок оценки: up to the 30th day post surgery]
• To compare between both groups, the rate of interventional radiology re-intervention (radio-guided drainage) [Срок оценки: up to the 30th day post surgery]
• To compare between both groups, the rate of laparoscopic re-intervention [Срок оценки: up to the 30th day post surgery]
• To compare between both groups, at post-operative day 30, the rate of re-intervention by laparotomy [Срок оценки: up to the 30th day post surgery]
• To compare between both groups, patient satisfaction 7 and 30 days post surgery [Срок оценки: 7 and 30 days post surgery]
• To compare between both groups, patient quality of life 7 and 30 days post surgery [Срок оценки: at inclusion and at 7 and 30 days post surgery]
• To evaluate the rate of conversion from outpatient to conventional care [Срок оценки: up to the 30th day post surgery]
• To estimate the cost of outpatient appendectomy management [Срок оценки: up to the 30th day post surgery]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 31 центр

• Hôpitaux Pédiatriques de Nice CHU - Lenval — Nice
• CHU de Nice — Nice
• CHU de Bordeaux — Bordeaux
• CH de Troyes — Troyes
• CHU Grenoble Alpes — La Tronche
• Hôpital Edouard HERRIOT — Lyon
• CHU de Saint-Etienne - Hôpital Nord — Saint-Priest-en-Jarez
• CH de Voiron — Voiron
• … и ещё 23 центра

Reunion · 2 центра

• CHU de La Réunion — Saint-Denis
• CHU de La Réunion — Saint-Pierre

Публикации

• Arvieux C, Tidadini F, Barbois S, Fontas E, Carles M, Gridel V, Orban JC, Quesada JL, Foote A, Cruzel C, Anthony S, Bulsei J, Hivelin C, Massalou D. SAME day amBulatory c (SAMBA): a multicenter, prospective, randomized clinical trial protocol. Trials. 2024 Sep 9;25(1):601. doi: 10.1186/s13063-024-08336-x. PMID 39252106

Идентификаторы

NCT: NCT05691348 · 21-API-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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