RecruitingNot ApplicableNCT05691348

Same Day Ambulatory Appendectomy (SAMBA)

Sponsor

Centre Hospitalier Universitaire de Nice

Enrollment

1,400 participants

Start Date

Jul 17, 2023

Study Type

INTERVENTIONAL

Conditions

Appendicitis

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

Min Age: 15 YearsMax Age: 74 Years

Plain Language Summary

Simplified for easier understanding

The SAMBA trial tests whether patients with uncomplicated acute appendicitis can safely be sent home on the same day as their appendix removal surgery (laparoscopic appendectomy), rather than staying overnight in the hospital. Same-day discharge works well for many surgical procedures, and this trial aims to confirm its safety and feasibility for appendicitis. You may be eligible if: - You are between 15 and 74 years old - Your BMI is 35 or below - You have uncomplicated acute appendicitis confirmed by imaging (ultrasound, CT, or MRI) with specific parameters (normal temperature, appendix diameter within range, no perforation or abscess) - Your pain is manageable with standard analgesics - You have someone to monitor you at home for 12 hours after discharge - You live within 20 minutes by car of a healthcare facility and have access to a phone - You are affiliated with a French health insurance scheme You may NOT be eligible if: - You have an ASA physical status score above 2 (significant medical conditions) - You have active cancer, a blood disorder, immunosuppressive treatment, or coagulopathy - You have had pelvic surgery previously - You are pregnant or breastfeeding - You are a minor without parental consent - There is suspicion of a tumor of the appendix (mucocele, carcinoid, adenocarcinoma) - Your appendicitis is being treated as an interval appendectomy after antibiotics Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREAmbulatory appendectomy

Appendectomy will be performed in outpatient surgery unit. Patient will be discharge from the hospital the same day as surgery

PROCEDUREConventional 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

Locations(33)

Hôpitaux Pédiatriques de Nice CHU - Lenval

Nice, Alpes Maritimes, France

CHU de Nice

Nice, Alpes-Maritimes, France

CHU de Bordeaux

Bordeaux, Aquitaine, France

CH de Troyes

Troyes, Aube, France

CHU Grenoble Alpes

La Tronche, Auvergne-Rhône-Alpes, France

Hôpital Edouard HERRIOT

Lyon, Auvergne-Rhône-Alpes, France

CHU de Saint-Etienne - Hôpital Nord

Saint-Priest-en-Jarez, Auvergne-Rhône-Alpes, France

CH de Voiron

Voiron, Auvergne-Rhône-Alpes, France

APHM Hôpital Nord

Marseille, Bouches-du-Rhône, France

CHU Minjo

Besançon, Bourgogne-Franche-Comté, France

CHU de Rennes

Rennes, Brittany Region, France

Hôpital Robert Debré - CHU de Reims

Reims, Grand Est, France

Hôpital Beaujon (APHP)

Clichy, Hauts de Seine, France

CHU Amiens-Picardie

Amiens, Hauts-de-France, France

Clinique de Saint-Omer

Blendecques, Hauts-de-France, France

HIA Percy

Clamart, Hauts-de-Seine, France

CHU de Tours

Tours, Indre Et Loire, France

CHU de Reims

Reims, Marne, France

CH de Dax

Dax, New Aquitaine, France

CH de Mont de Marsan

Mont-de-Marsan, New Aquitaine, France

Hôpital Cochin APHP

Paris, Paris, France

CHU d'Angers

Angers, Pays de la Loire Region, France

Hôpital d'Instruction des armées Laveran

Marseille, Provence-Alpes-Côte d'Azur Region, France

Hôpital d'Instruction des armées Sainte Anne - BCRM Toulon

Toulon, Provence-Alpes-Côte d'Azur Region, France

Clinique du Val d'Ouest

Écully, Rhones-Alpes, France

Hôpital Avicenne

Bobigny, Île-de-France Region, France

Hôpital Louis-Mourier

Colombes, Île-de-France Region, France

APHP Pitié Salpetrière

Paris, Île-de-France Region, France

APHP Lariboisière

Paris, Île-de-France Region, France

Hia Begin

Saint-Mandé, Île-de-France Region, France

Clinique de l'Estrée

Stains, Île-de-France Region, France

CHU de La Réunion

Saint-Denis, La Réunion, Reunion

CHU de La Réunion

Saint-Pierre, La Réunion, Reunion

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NCT05691348

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