Clinical trial NCT05691348: Same Day Ambulatory Appendectomy (SAMBA)
Official title: Same Day Ambulatory Appendectomy (SAMBA)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Appendicitis
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 1400
Sex: ALL
Minimum age (years): 15
Maximum age (years): 74
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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, 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: 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

Primary outcomes:
measure: 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.
timeFrame: 30 days post surgery
Secondary outcomes:
measure: To compare between both groups, at post-operative day 30, the delay from diagnosis to appendectomy
timeFrame: 30 days post surgery
measure: To compare between both groups, at post-operative day 30, the real cumulated length of hospitalization
timeFrame: 30 days post surgery
measure: To compare between both groups, at post-operative day 30, the rehospitalization rate
timeFrame: 30 days post surgery
measure: To compare between both groups, the mild morbidity (Clavien-Dindo I-II) during 30 days post surgery
timeFrame: up to the 30th day post surgery
measure: To compare between both groups, the severe morbidity (Clavien-Dindo III, IV, V) during 30 days post surgery
timeFrame: up to the 30th day post surgery
measure: To compare between both groups, the rate of interventional radiology re-intervention (radio-guided drainage)
timeFrame: up to the 30th day post surgery
measure: To compare between both groups, the rate of laparoscopic re-intervention
timeFrame: up to the 30th day post surgery
measure: To compare between both groups, at post-operative day 30, the rate of re-intervention by laparotomy
timeFrame: up to the 30th day post surgery
measure: To compare between both groups, patient satisfaction 7 and 30 days post surgery
timeFrame: 7 and 30 days post surgery
measure: To compare between both groups, patient quality of life 7 and 30 days post surgery
timeFrame: at inclusion and at 7 and 30 days post surgery
measure: To evaluate the rate of conversion from outpatient to conventional care
timeFrame: up to the 30th day post surgery
measure: To estimate the cost of outpatient appendectomy management
timeFrame: up to the 30th day post surgery
measure: To study the economic impact (utility) of outpatient appendectomy management compared to conventional hospitalization
timeFrame: up to the 30th day post surgery
measure: To study the economic impact (effectiveness) of outpatient appendectomy management compared to conventional hospitalization
timeFrame: up to the 30th day post surgery
measure: To study the generalization of outpatient appendectomy management in all French hospitals at the budgetary level
timeFrame: up to the 30th day post surgery
measure: To study the generalization of outpatient appendectomy management in all French hospitals at a strategic level
timeFrame: up to the 30th day post surgery
Other outcomes:
Locations:
city: Nice
country: France
facility: Hôpitaux Pédiatriques de Nice CHU - Lenval
state: Alpes Maritimes
city: Nice
country: France
facility: CHU de Nice
state: Alpes-Maritimes
city: Bordeaux
country: France
facility: CHU de Bordeaux
state: Aquitaine
city: Troyes
country: France
facility: CH de Troyes
state: Aube
city: La Tronche
country: France
facility: CHU Grenoble Alpes
state: Auvergne-Rhône-Alpes
city: Lyon
country: France
facility: Hôpital Edouard HERRIOT
state: Auvergne-Rhône-Alpes
city: Saint-Priest-en-Jarez
country: France
facility: CHU de Saint-Etienne - Hôpital Nord
state: Auvergne-Rhône-Alpes
city: Voiron
country: France
facility: CH de Voiron
state: Auvergne-Rhône-Alpes
city: Marseille
country: France
facility: APHM Hôpital Nord
state: Bouches-du-Rhône
city: Besançon
country: France
facility: CHU Minjo
state: Bourgogne-Franche-Comté
city: Rennes
country: France
facility: CHU de Rennes
state: Bretagne
city: Reims
country: France
facility: Hôpital Robert Debré - CHU de Reims
state: Grand Est
city: Clichy
country: France
facility: Hôpital Beaujon (APHP)
state: Hauts De Seine
city: Amiens
country: France
facility: CHU Amiens-Picardie
state: Hauts-de-France
city: Blendecques
country: France
facility: Clinique de Saint-Omer
state: Hauts-de-France
city: Clamart
country: France
facility: HIA Percy
state: Hauts-de-Seine
city: Paris
country: France
facility: APHP Pitié Salpetrière
state: Ile De France
city: Paris
country: France
facility: APHP Lariboisière
state: Ile De France
city: Stains
country: France
facility: Clinique de l'Estrée
state: Ile De France
city: Tours
country: France
facility: CHU de Tours
state: Indre Et Loire
city: Reims
country: France
facility: CHU de Reims
state: Marne
city: Dax
country: France
facility: CH de Dax
state: Nouvelle-Aquitaine
city: Mont-de-Marsan
country: France
facility: CH de Mont de Marsan
state: Nouvelle-Aquitaine
city: Angers
country: France
facility: CHU d'Angers
state: Pays De La Loire
city: Marseille
country: France
facility: Hôpital d'Instruction des armées Laveran
state: Provence-Alpes-Côte d'Azur
city: Toulon
country: France
facility: Hôpital d'Instruction des armées Sainte Anne - BCRM Toulon
state: Provence-Alpes-Côte d'Azur
city: Ecully
country: France
facility: Clinique du Val d'Ouest
state: Rhones-Alpes
city: Paris
country: France
facility: Hôpital Cochin APHP
city: Bobigny
country: France
facility: Hôpital Avicenne
state: Île-de-France
city: Colombes
country: France
facility: Hôpital Louis-Mourier
state: Île-de-France
city: Saint-Mandé
country: France
facility: Hia Begin
state: Île-de-France
city: Saint-Denis
country: Réunion
facility: CHU de La Réunion
state: La Réunion
city: Saint-Pierre
country: Réunion
facility: CHU de La Réunion
state: La Réunion
Study officials:
References: