Same Day Ambulatory Appendectomy (SAMBA)

NCT05691348 | Recruiting DMC

• 1 other identifier: 21-API-01
• Study Type: interventional
• Target: 1,400
• Locations: 2 countries
• Sites: 33

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. 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. 2.Improved patient satisfaction compared to waiting for hours in the emergency department due to lack of hospital beds.
3. 3.Non-inferiority of care in an outpatient unit in terms of quality and safety in day hospitalization.
4. 4.Significant decrease in the overall cost of this pathology as a result of a reduction in the hospital stay.

Conditions

Appendicitis

Outcome Measures

Primary Outcomes (1)

• 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.

  Morbi-mortality will be assessed by classifying post-operative complications according to Clavien-Dindo classification. It will be compared between both groups ("ambulatory pathway" versus "conventional hospitalization" CONV) on the 30th postoperative day. The Clavien-Dindo classification was originally published in 2004 in the Annals of Surgery for elective general surgery. Later, it has been objectively validated for all surgical specialties. This classification ranks complications from 0 (no complication) to 5 (death). Complications that potentially lead to long-lasting disability after discharge (e.g.: paralysis of a vocal cord after thyroid surgery) are highlighted in the present classification by a suffix ("d" for disability). This suffix indicates that a long-term follow-up is required to comprehensively evaluate the outcome and related long-term quality of life.

  30 days post surgery

Secondary Outcomes (16)

• To compare between both groups, at post-operative day 30, the delay from diagnosis to appendectomy

  30 days post surgery

• To compare between both groups, at post-operative day 30, the real cumulated length of hospitalization

  30 days post surgery

• To compare between both groups, at post-operative day 30, the rehospitalization rate

  30 days post surgery

• To compare between both groups, the mild morbidity (Clavien-Dindo I-II) during 30 days post surgery

  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

  up to the 30th day post surgery

Study Arms (2)

Ambulatory pathway

EXPERIMENTAL

Procedure: Ambulatory appendectomy

Conventional hospitalisation

ACTIVE COMPARATOR

Procedure: Conventional appendectomy

Interventions

Conventional appendectomy PROCEDURE

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

Conventional hospitalisation

Ambulatory appendectomy PROCEDURE

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

Ambulatory pathway

Eligibility Criteria

• Age: 15 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (33)

Hôpitaux Pédiatriques de Nice CHU - Lenval

Nice, Alpes Maritimes, 06200, France

NOT YET RECRUITING

CHU de Nice

Nice, Alpes-Maritimes, 06000, France

RECRUITING

CHU de Bordeaux

Bordeaux, Aquitaine, 33076, France

NOT YET RECRUITING

CH de Troyes

Troyes, Aube, 10000, France

NOT YET RECRUITING

CHU Grenoble Alpes

La Tronche, Auvergne-Rhône-Alpes, 38700, France

RECRUITING

Hôpital Edouard HERRIOT

Lyon, Auvergne-Rhône-Alpes, 69003, France

RECRUITING

CHU de Saint-Etienne - Hôpital Nord

Saint-Priest-en-Jarez, Auvergne-Rhône-Alpes, 42270, France

RECRUITING

CH de Voiron

Voiron, Auvergne-Rhône-Alpes, 38500, France

RECRUITING

APHM Hôpital Nord

Marseille, Bouches-du-Rhône, 13326, France

RECRUITING

CHU Minjo

Besançon, Bourgogne-Franche-Comté, 25000, France

NOT YET RECRUITING

CHU de Rennes

Rennes, Brittany Region, 35000, France

NOT YET RECRUITING

Hôpital Robert Debré - CHU de Reims

Reims, Grand Est, 51092, France

RECRUITING

Hôpital Beaujon (APHP)

Clichy, Hauts de Seine, 92110, France

NOT YET RECRUITING

CHU Amiens-Picardie

Amiens, Hauts-de-France, 80054, France

RECRUITING

Clinique de Saint-Omer

Blendecques, Hauts-de-France, 62575, France

NOT YET RECRUITING

HIA Percy

Clamart, Hauts-de-Seine, 92140, France

NOT YET RECRUITING

CHU de Tours

Tours, Indre Et Loire, 37044, France

NOT YET RECRUITING

CHU de Reims

Reims, Marne, 51100, France

NOT YET RECRUITING

CH de Dax

Dax, Nouvelle-Aquitaine, 40107, France

RECRUITING

CH de Mont de Marsan

Mont-de-Marsan, Nouvelle-Aquitaine, 40000, France

RECRUITING

Hôpital Cochin APHP

Paris, Paris, 75014, France

NOT YET RECRUITING

CHU d'Angers

Angers, Pays de la Loire Region, 49933, France

RECRUITING

Hôpital d'Instruction des armées Laveran

Marseille, Provence-Alpes-Côte d'Azur Region, 13384, France

RECRUITING

Hôpital d'Instruction des armées Sainte Anne - BCRM Toulon

Toulon, Provence-Alpes-Côte d'Azur Region, 83800, France

RECRUITING

Clinique du Val d'Ouest

Écully, Rhones-Alpes, 69130, France

NOT YET RECRUITING

Hôpital Avicenne

Bobigny, Île-de-France Region, 93000, France

RECRUITING

Hôpital Louis-Mourier

Colombes, Île-de-France Region, 92700, France

NOT YET RECRUITING

APHP Pitié Salpetrière

Paris, Île-de-France Region, 75013, France

NOT YET RECRUITING

APHP Lariboisière

Paris, Île-de-France Region, 75475, France

RECRUITING

Hia Begin

Saint-Mandé, Île-de-France Region, 94160, France

NOT YET RECRUITING

Clinique de l'Estrée

Stains, Île-de-France Region, 93240, France

NOT YET RECRUITING

CHU de La Réunion

Saint-Denis, La Réunion, 97400, Reunion

RECRUITING

CHU de La Réunion

Saint-Pierre, La Réunion, 97448, Reunion

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Central Study Contacts

Catherine ARVIEUX

CONTACT

04 43 98 52 42; catherine.arvieux@intradef.gouv.fr

Damien MASSALOU

CONTACT

04 92 03 33 13; massalou.d@chu-nice.Fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: January 20, 2023
• Study Start: July 17, 2023
• Primary Completion (Estimated): January 17, 2028
• Study Completion (Estimated): January 17, 2028
• Last Updated: March 31, 2026

Record last verified: 2025-03

Locations

FR (31); RE (2)