Same Day Ambulatory Appendectomy
Same Day Ambulatory Appendectomy (SAMBA)
This study tests whether doing appendectomies on the same day without an overnight hospital stay can safely help people with uncomplicated appendicitis feel better and improve their overall care experience.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1400 (estimated) |
| Ages | 15 Years to 74 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nice Academic / other |
| Locations | 33 sites (Nice, Alpes Maritimes and 32 other locations) |
| Trial ID | NCT05691348 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of performing appendectomies on an outpatient basis, aiming to optimize patient care pathways and reduce hospital stays. It focuses on patients with uncomplicated acute appendicitis, assessing both the safety and quality of care in an outpatient setting compared to traditional inpatient procedures. The study seeks to enhance patient satisfaction by minimizing wait times in emergency departments and aims to lower healthcare costs associated with appendicitis treatment.
Who should consider this trial
Good fit: Ideal candidates are patients aged 15-74 with uncomplicated acute appendicitis and specific clinical criteria.
Not a fit: Patients with complicated appendicitis or those who do not meet the eligibility criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve patient experiences and reduce healthcare costs associated with appendicitis treatment.
How similar studies have performed: Previous studies have shown promising results for outpatient appendectomies, indicating that this approach is gaining acceptance in clinical practice.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 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
Where this trial is running
Nice, Alpes Maritimes and 32 other locations
- Hôpitaux Pédiatriques de Nice CHU - Lenval — Nice, Alpes Maritimes, France (Not_yet_recruiting)
- CHU de Nice — Nice, Alpes-Maritimes, France (Recruiting)
- CHU de Bordeaux — Bordeaux, Aquitaine, France (Not_yet_recruiting)
- CH de Troyes — Troyes, Aube, France (Not_yet_recruiting)
- CHU Grenoble Alpes — La Tronche, Auvergne-Rhône-Alpes, France (Recruiting)
- Hôpital Edouard HERRIOT — Lyon, Auvergne-Rhône-Alpes, France (Recruiting)
- CHU de Saint-Etienne - Hôpital Nord — Saint-Priest-en-Jarez, Auvergne-Rhône-Alpes, France (Recruiting)
- CH de Voiron — Voiron, Auvergne-Rhône-Alpes, France (Recruiting)
- APHM Hôpital Nord — Marseille, Bouches-du-Rhône, France (Recruiting)
- CHU Minjo — Besançon, Bourgogne-Franche-Comté, France (Not_yet_recruiting)
- CHU de Rennes — Rennes, Brittany Region, France (Not_yet_recruiting)
- Hôpital Robert Debré - CHU de Reims — Reims, Grand Est, France (Recruiting)
- Hôpital Beaujon (APHP) — Clichy, Hauts de Seine, France (Not_yet_recruiting)
- CHU Amiens-Picardie — Amiens, Hauts-de-France, France (Recruiting)
- Clinique de Saint-Omer — Blendecques, Hauts-de-France, France (Not_yet_recruiting)
- HIA Percy — Clamart, Hauts-de-Seine, France (Not_yet_recruiting)
- CHU de Tours — Tours, Indre Et Loire, France (Not_yet_recruiting)
- CHU de Reims — Reims, Marne, France (Not_yet_recruiting)
- CH de Dax — Dax, New Aquitaine, France (Recruiting)
- CH de Mont de Marsan — Mont-de-Marsan, New Aquitaine, France (Recruiting)
- Hôpital Cochin APHP — Paris, Paris, France (Not_yet_recruiting)
- CHU d'Angers — Angers, Pays de la Loire Region, France (Recruiting)
- Hôpital d'Instruction des armées Laveran — Marseille, Provence-Alpes-Côte d'Azur Region, France (Recruiting)
- Hôpital d'Instruction des armées Sainte Anne - BCRM Toulon — Toulon, Provence-Alpes-Côte d'Azur Region, France (Recruiting)
- Clinique du Val d'Ouest — Écully, Rhones-Alpes, France (Not_yet_recruiting)
- Hôpital Avicenne — Bobigny, Île-de-France Region, France (Recruiting)
- Hôpital Louis-Mourier — Colombes, Île-de-France Region, France (Not_yet_recruiting)
- APHP Pitié Salpetrière — Paris, Île-de-France Region, France (Not_yet_recruiting)
- APHP Lariboisière — Paris, Île-de-France Region, France (Recruiting)
- Hia Begin — Saint-Mandé, Île-de-France Region, France (Not_yet_recruiting)
- Clinique de l'Estrée — Stains, Île-de-France Region, France (Not_yet_recruiting)
- CHU de La Réunion — Saint-Denis, La Réunion, Reunion (Recruiting)
- CHU de La Réunion — Saint-Pierre, La Réunion, Reunion (Recruiting)
Study contacts
- Study coordinator: Catherine ARVIEUX
- Email: catherine.arvieux@intradef.gouv.fr
- Phone: 04 43 98 52 42
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.