Same Day Ambulatory Appendectomy (SAMBA)

Recruiting now · Not applicable

Conditions studied: Appendicitis

In brief

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.

Key facts

Study ID

NCT05691348

Run by

Centre Hospitalier Universitaire de Nice

People needed

1400

Starts

2023-07-17

Expected to finish

2028-01-17

Last updated by the study team

2026-03-31

Who can join

Age: 15 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• CHU de Nice — Nice, Alpes-Maritimes, France (enrolling)
• CH de Dax — Dax, New Aquitaine, France (enrolling)
• CH de Mont de Marsan — Mont-de-Marsan, New Aquitaine, France (enrolling)
• CHU Grenoble Alpes — La Tronche, Auvergne-Rhône-Alpes, France (enrolling)
• CHU d'Angers — Angers, Pays de la Loire Region, France (enrolling)
• Hôpital d'Instruction des armées Laveran — Marseille, Provence-Alpes-Côte d'Azur Region, France (enrolling)
• Hôpital d'Instruction des armées Sainte Anne - BCRM Toulon — Toulon, Provence-Alpes-Côte d'Azur Region, France (enrolling)
• Hôpital Robert Debré - CHU de Reims — Reims, Grand Est, France (enrolling)
• Hôpital Avicenne — Bobigny, Île-de-France Region, France (enrolling)
• Hôpital Edouard HERRIOT — Lyon, Auvergne-Rhône-Alpes, France (enrolling)
• CHU Amiens-Picardie — Amiens, Hauts-de-France, France (enrolling)
• APHP Lariboisière — Paris, Île-de-France Region, France (enrolling)
• CHU de Saint-Etienne - Hôpital Nord — Saint-Priest-en-Jarez, Auvergne-Rhône-Alpes, France (enrolling)
• CH de Voiron — Voiron, Auvergne-Rhône-Alpes, France (enrolling)
• CHU de La Réunion — Saint-Denis, La Réunion, Reunion (enrolling)
• CHU de La Réunion — Saint-Pierre, La Réunion, Reunion (enrolling)
• APHM Hôpital Nord — Marseille, Bouches-du-Rhône, France (enrolling)
• CHU de Tours — Tours, Indre Et Loire, France
• CHU de Bordeaux — Bordeaux, Aquitaine, France
• CH de Troyes — Troyes, Aube, France
• CHU Minjo — Besançon, Bourgogne-Franche-Comté, France
• CHU de Rennes — Rennes, Brittany Region, France
• Hôpital Beaujon (APHP) — Clichy, Hauts de Seine, France
• Clinique de Saint-Omer — Blendecques, Hauts-de-France, France
• HIA Percy — Clamart, Hauts-de-Seine, France

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.