Same Day Ambulatory Appendectomy (SAMBA) (SAMBA)

March 30, 2026 updated by: Centre Hospitalier Universitaire de Nice

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Alpes Maritimes
      • Nice, Alpes Maritimes, France, 06200
        • Not yet recruiting
        • Hôpitaux Pédiatriques de Nice CHU - Lenval
        • Contact:
        • Principal Investigator:
          • Jean BREAUD
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06000
        • Recruiting
        • CHU de Nice
        • Contact:
        • Principal Investigator:
          • Damien MASSALOU
    • Aquitaine
      • Bordeaux, Aquitaine, France, 33076
        • Not yet recruiting
        • CHU de Bordeaux
        • Contact:
        • Principal Investigator:
          • Vincent DUBUISSON
    • Aube
      • Troyes, Aube, France, 10000
        • Not yet recruiting
        • CH de Troyes
        • Contact:
        • Principal Investigator:
          • Geoffrey LEDOUX
    • Auvergne-Rhône-Alpes
      • La Tronche, Auvergne-Rhône-Alpes, France, 38700
        • Recruiting
        • CHU Grenoble Alpes
        • Contact:
        • Principal Investigator:
          • Julio ABBA
      • Lyon, Auvergne-Rhône-Alpes, France, 69003
        • Recruiting
        • Hôpital Edouard Herriot
        • Contact:
        • Principal Investigator:
          • Olivier MONNEUSE
      • Saint-Priest-en-Jarez, Auvergne-Rhône-Alpes, France, 42270
      • Voiron, Auvergne-Rhône-Alpes, France, 38500
        • Recruiting
        • CH de Voiron
        • Contact:
        • Principal Investigator:
          • Romain RIBOUD
    • Bouches-du-Rhône
      • Marseille, Bouches-du-Rhône, France, 13326
        • Recruiting
        • Aphm Hopital Nord
        • Contact:
        • Principal Investigator:
          • Laura BEYER
    • Bourgogne-Franche-Comté
      • Besançon, Bourgogne-Franche-Comté, France, 25000
        • Not yet recruiting
        • CHU Minjo
        • Contact:
        • Principal Investigator:
          • Célia TURCO
    • Brittany Region
      • Rennes, Brittany Region, France, 35000
    • Grand Est
      • Reims, Grand Est, France, 51092
        • Recruiting
        • Hôpital Robert Debré - CHU de Reims
        • Contact:
        • Principal Investigator:
          • Rami RHAIEM
    • Hauts de Seine
      • Clichy, Hauts de Seine, France, 92110
        • Not yet recruiting
        • Hôpital Beaujon (APHP)
        • Contact:
        • Principal Investigator:
          • Laurence LACAZE
    • Hauts-de-France
      • Amiens, Hauts-de-France, France, 80054
        • Recruiting
        • CHU Amiens-Picardie
        • Contact:
        • Principal Investigator:
          • Elodie HARAUX
      • Blendecques, Hauts-de-France, France, 62575
        • Not yet recruiting
        • Clinique de Saint-Omer
        • Contact:
        • Principal Investigator:
          • André DABROWSKI
    • Hauts-de-Seine
      • Clamart, Hauts-de-Seine, France, 92140
        • Not yet recruiting
        • Hia Percy
        • Contact:
        • Principal Investigator:
          • Emmanuel HORNEZ
    • Indre Et Loire
      • Tours, Indre Et Loire, France, 37044
        • Not yet recruiting
        • Chu de Tours
        • Contact:
        • Principal Investigator:
          • Anne LE TOUZE
    • Marne
      • Reims, Marne, France, 51100
        • Not yet recruiting
        • CHU de Reims
        • Contact:
        • Principal Investigator:
          • Nadia BOUDAOUD
    • Nouvelle-Aquitaine
      • Dax, Nouvelle-Aquitaine, France, 40107
        • Recruiting
        • CH de Dax
        • Contact:
        • Principal Investigator:
          • Benjamin BLANC
      • Mont-de-Marsan, Nouvelle-Aquitaine, France, 40000
        • Recruiting
        • CH de Mont de Marsan
        • Contact:
        • Principal Investigator:
          • Rémy CHEVALIER
    • Paris
      • Paris, Paris, France, 75014
        • Not yet recruiting
        • Hôpital Cochin APHP
        • Contact:
        • Principal Investigator:
          • FUKS David
    • Pays de la Loire Region
      • Angers, Pays de la Loire Region, France, 49933
        • Recruiting
        • CHU d'Angers
        • Contact:
          • Emilie LERMITE
          • Phone Number: +33 02 41 35 36 18
        • Contact:
          • elermite@chu-angers.fr
        • Principal Investigator:
          • Emilie LERMITE
    • Provence-Alpes-Côte d'Azur Region
      • Marseille, Provence-Alpes-Côte d'Azur Region, France, 13384
        • Recruiting
        • Hôpital d'Instruction des Armées Laveran
        • Contact:
        • Principal Investigator:
          • Yvain GOUDARD
      • Toulon, Provence-Alpes-Côte d'Azur Region, France, 83800
        • Recruiting
        • Hôpital d'Instruction des armées Sainte Anne - BCRM Toulon
        • Contact:
        • Principal Investigator:
          • Stéphane BOURGOUIN
    • Rhones-Alpes
      • Écully, Rhones-Alpes, France, 69130
        • Not yet recruiting
        • Clinique du Val d'Ouest
        • Contact:
        • Principal Investigator:
          • Philippe GUILLEM
    • Île-de-France Region
      • Bobigny, Île-de-France Region, France, 93000
        • Recruiting
        • Hôpital Avicenne
        • Contact:
        • Principal Investigator:
          • Christophe TRESALLET
      • Colombes, Île-de-France Region, France, 92700
        • Not yet recruiting
        • Hôpital Louis-Mourier
        • Contact:
        • Principal Investigator:
          • David MOSZKOWICZ
      • Paris, Île-de-France Region, France, 75013
        • Not yet recruiting
        • APHP Pitié Salpetrière
        • Contact:
        • Principal Investigator:
          • Sébastien GAUJOUX
      • Paris, Île-de-France Region, France, 75475
        • Recruiting
        • APHP Lariboisière
        • Contact:
        • Principal Investigator:
          • Karine PAUTRAT
      • Saint-Mandé, Île-de-France Region, France, 94160
        • Not yet recruiting
        • Hia Begin
        • Contact:
        • Principal Investigator:
          • Catherine ARVIEUX
      • Stains, Île-de-France Region, France, 93240
        • Not yet recruiting
        • Clinique de l'Estrée
        • Contact:
        • Principal Investigator:
          • Yamina LADJICI
  • Reunion
    • La Réunion
      • Saint-Denis, La Réunion, Reunion, 97400
      • Saint-Pierre, La Réunion, Reunion, 97448

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 74 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ambulatory pathway
Procedure: Ambulatory appendectomy
Appendectomy will be performed in outpatient surgery unit. Patient will be discharge from the hospital the same day as surgery
Active Comparator: Conventional hospitalisation
Procedure: Conventional 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 30 days post surgery

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare between both groups, at post-operative day 30, the delay from diagnosis to appendectomy
Time Frame: 30 days post surgery
The delay from diagnosis to appendectomy is defined as the time between the performance of the CT scan (or ultrasound or MRI) for diagnosis and the skin incision in the operating room. This time is expressed in minutes.
30 days post surgery
To compare between both groups, at post-operative day 30, the rehospitalization rate
Time Frame: 30 days post surgery
All re-hospitalization(s) after initial discharge will be counted until 30 days post surgery, whatever the cause or type of hospitalization.
30 days post surgery
To compare between both groups, the mild morbidity (Clavien-Dindo I-II) during 30 days post surgery
Time Frame: up to the 30th day post surgery
Post-operative mild morbidity will be assessed with the Clavien-Dindo classification (grade I, II) up to the 30th day post surgery. 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).
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
Time Frame: up to the 30th day post surgery
Post-operative mild morbidity will be assessed with the severe morbidity (Clavien-Dindo III, IV, V) up to the 30th day post surgery. 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).
up to the 30th day post surgery
To compare between both groups, the rate of interventional radiology re-intervention (radio-guided drainage)
Time Frame: up to the 30th day post surgery
All the Clavien-Dindo interventional radiology re-interventions (radio-guided drainage) performed in relation with the appendicitis and any potential complications will be recorded up to the 30th day post surgery.
up to the 30th day post surgery
To compare between both groups, the rate of laparoscopic re-intervention
Time Frame: up to the 30th day post surgery
All laparoscopic re-interventions performed in relation with the appendectomy and the potential complications will be recorded up to the 30th day post surgery.
up to the 30th day post surgery
To compare between both groups, at post-operative day 30, the rate of re-intervention by laparotomy
Time Frame: up to the 30th day post surgery
All the laparotomic re-interventions performed in relation with the appendectomy and the potential complications will be recorded up to the 30th day post surgery.
up to the 30th day post surgery
To compare between both groups, patient satisfaction 7 and 30 days post surgery
Time Frame: 7 and 30 days post surgery
Patient satisfaction will be assessed using a numerical scale from 0 to 10, using the Link4Life app. Zero '0', placed on the left, means that the patient is not satisfied at all with her/his postoperative course; '10', placed on the right, means that the patient is extremely satisfied with her/his postoperative course. If the patient does not have access or does not wish to access Link4Life, a clinical research assistant from the investigating center will collect the patient's satisfaction through a phone call. The questions that will be asked are: "How satisfied are you with your care?"; "are you in pain and if so, how severe is it?"; "Were you worried about same-day discharge (for patients in the outpatient group)?
7 and 30 days post surgery
To compare between both groups, patient quality of life 7 and 30 days post surgery
Time Frame: at inclusion and at 7 and 30 days post surgery
Quality of life will be evaluated using the EuroQol five-dimension questionnaire (EQ-5D-5L), at inclusion, and at 7 and 30 days post surgery.The EQ-5D-5L comprises a descriptive system and a visual analogue scale (VAS). The descriptive system is composed of five health dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) with 5 levels of health (no problems, slight problems, moderate problems, severe problems and extreme problems). For each of the 5 dimensions, the participant's answer is converted to a number between 1 and 5, expressing the health state reported. The responses are combined to produce a five-digit number describing the participant's health status which is converted to a utility value from the country specific value set. The French EQ-5D-5L value set has utility between -0.530 (health condition worse than death) and 1 (best possible health). The VAS records the self-rated health status on a graduated scale from 0 to 100.
at inclusion and at 7 and 30 days post surgery
To evaluate the rate of conversion from outpatient to conventional care
Time Frame: up to the 30th day post surgery
A conversion will be defined as a patient randomized to the outpatient care group who is finally treated following the conventional care procedure, whatever the reason
up to the 30th day post surgery
To estimate the cost of outpatient appendectomy management
Time Frame: up to the 30th day post surgery
The cost will be estimated by the hospital cost (intervention and outpatient stay).
up to the 30th day post surgery
To study the economic impact (utility) of outpatient appendectomy management compared to conventional hospitalization
Time Frame: up to the 30th day post surgery
The economic impact will be studied with a cost-utility analysis which will estimate the incremental cost-effectiveness ratio (ICER) in cost per QALY (quality adjusted life years) gained.
up to the 30th day post surgery
To study the economic impact (effectiveness) of outpatient appendectomy management compared to conventional hospitalization
Time Frame: up to the 30th day post surgery
The economic impact will be studied with a cost-effectiveness analysis which will estimate the ICER in cost per patient without rehospitalization.
up to the 30th day post surgery
To study the generalization of outpatient appendectomy management in all French hospitals at the budgetary level
Time Frame: up to the 30th day post surgery
The generalization of outpatient appendectomy management will be studied with a budget impact model which will estimate the consequences in terms of costs
up to the 30th day post surgery
To study the generalization of outpatient appendectomy management in all French hospitals at a strategic level
Time Frame: up to the 30th day post surgery
The generalization of outpatient appendectomy management will be studied with QALYs (quality adjusted life years) of the adoption of the outpatient strategy in all French hospitals
up to the 30th day post surgery
To compare between both groups, at post-operative day 30, the real cumulated length of hospitalization
Time Frame: 30 days post surgery
The real cumulated length of hospitalization is the cumulative length of the entire hospital stay(s) in hours until the 30th postoperative day (rehospitalizations included). The length of stay in a non-hospital health structure, such as a convalescent center, will not be included.
30 days post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 17, 2023

Primary Completion (Estimated)

January 17, 2028

Study Completion (Estimated)

January 17, 2028

Study Registration Dates

First Submitted

January 9, 2023

First Submitted That Met QC Criteria

January 18, 2023

First Posted (Actual)

January 20, 2023

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-API-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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