AppendicitisSAMBANCT05691348
Same Day Ambulatory Appendectomy (SAMBA)
A study testing Ambulatory appendectomy and Conventional appendectomy in people with Appendicitis, run by Centre Hospitalier Universitaire de Nice at 33 sites in 2 countries.
Trial 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)… Read more about this study
- Who is it for?
- Ages 15 to 74 years
- Conditions the study is for
- Appendicitis
- What is being tested?
- Ambulatory appendectomy and Conventional appendectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,400 participants
- Where
- 33 sitesin 2 countries
- Study dates
- 17 Jul 2023to 17 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 74 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 18Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
33 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
33 sites in 2 countries
France31 sites, 31 recruiting
- Recruiting
CHU Amiens-Picardie
Amiens, Hauts-de-France, 80054
Elodie HARAUX, 06 61 78 41 15 ext. +33, haraux.elodie@chu-amiens.fr
Elodie HARAUX
- Recruiting
CHU d'Angers
Angers, Pays de la Loire Region, 49933
Emilie LERMITE, 02 41 35 36 18 ext. +33
elermite@chu-angers.fr
- Not yet recruiting
CHU Minjo
Besançon, Bourgogne-Franche-Comté, 25000
Célia TURCO, 03 81 66 83 22 ext. +33, cturco@chu-besancon.fr
Célia TURCO
- Not yet recruiting
Clinique de Saint-Omer
Blendecques, Hauts-de-France, 62575
André DABROWSKI, a.dabrowski@free.fr
André DABROWSKI
- Recruiting
Hôpital Avicenne
Bobigny, Île-de-France Region, 93000
Christophe TRESALLET, 01 48 02 61 95 ext. +33, christophe.tresallet@aphp.fr
Christophe TRESALLET
- Not yet recruiting
CHU de Bordeaux
Bordeaux, Aquitaine, 33076
Vincent DUBUISSON, 05 56 79 56 79 ext. +33, vincent.dubuisson@chu-bordeaux.fr
Vincent DUBUISSON
- Not yet recruiting
HIA Percy
Clamart, Hauts-de-Seine, 92140
Emmanuel HORNEZ, 01 41 46 61 67 ext. +33, emmanuelhornez@gmail.com
Emmanuel HORNEZ
- Not yet recruiting
Hôpital Beaujon (APHP)
Clichy, Hauts de Seine, 92110
LACAZE Laurence, laurence.lacaze@aphp.fr
Laurence LACAZE
- Not yet recruiting
Hôpital Louis-Mourier
Colombes, Île-de-France Region, 92700
David MOSZKOWICZ, david.moszkowicz@aphp.fr
David MOSZKOWICZ
- Recruiting
CH de Dax
Dax, New Aquitaine, 40107
Benjamin BLANC, 05 58 91 66 43, blancb@ch-dax.fr
Benjamin BLANC
- Not yet recruiting
Clinique du Val d'Ouest
Écully, Rhones-Alpes, 69130
Philippe GUILLEM, 04 72 19 31 75 ext. +33, docteurphguillem@outlook.com
Philippe GUILLEM
- Recruiting
CHU Grenoble Alpes
La Tronche, Auvergne-Rhône-Alpes, 38700
Julio ABBA, 06 63 68 33 94 ext. +33, JAbba@chu-grenoble.fr
Julio ABBA
- Recruiting
Hôpital Edouard HERRIOT
Lyon, Auvergne-Rhône-Alpes, 69003
Olivier MONNEUSE, 04 72 11 01 02 ext. +33, olivier.monneuse@chu-lyon.fr
Olivier MONNEUSE
- Recruiting
APHM Hôpital Nord
Marseille, Bouches-du-Rhône, 13326
Laura BEYER, 04 91 96 50 90 ext. +33, laura.beyer@ap-hm.fr
Laura BEYER
- Recruiting
Hôpital d'Instruction des armées Laveran
Marseille, Provence-Alpes-Côte d'Azur Region, 13384
Yvain GOUDARD, 04 91 61 73 21 ext. +33, ygoudard.laveran@gmail.com
Yvain GOUDARD
- Recruiting
CH de Mont de Marsan
Mont-de-Marsan, New Aquitaine, 40000
Rémy CHEVALIER, 05 58 05 11 28 ext. +33, remy.chevalier@ch-mdm.fr
Rémy CHEVALIER
- Not yet recruiting
Hôpitaux Pédiatriques de Nice CHU - Lenval
Nice, Alpes Maritimes, 06200
Jean BREAUD, 04 92 03 03 16 ext. +33, breaud.j@pediatrie-chulenval-nice.fr
Jean BREAUD
- Recruiting
CHU de Nice
Nice, Alpes-Maritimes, 06000
Damien MASSALOU, 0492033313 ext. +33, massalou.d@chu-nice.Fr
Damien MASSALOU
- Not yet recruiting
Hôpital Cochin APHP
Paris, Paris, 75014
FUKS David, david.fuks@aphp.fr
FUKS David
- Not yet recruiting
APHP Pitié Salpetrière
Paris, Île-de-France Region, 75013
Sébastien GAUJOUX, 01 58 41 50 09 ext. +33, sebastien.gaujoux@aphp.fr
Sébastien GAUJOUX
- Recruiting
APHP Lariboisière
Paris, Île-de-France Region, 75475
Karine PAUTRAT, karine.pautrat@aphp.fr
Karine PAUTRAT
- Recruiting
Hôpital Robert Debré - CHU de Reims
Reims, Grand Est, 51092
Rami RHAIEM, 03 26 78 70 79 ext. +33, rrhaiem@chu-reims.fr
Rami RHAIEM
- Not yet recruiting
CHU de Reims
Reims, Marne, 51100
Nadia BOUDAOUD, nboudaoud@chu-reims.fr
Nadia BOUDAOUD
- Not yet recruiting
CHU de Rennes
Rennes, Brittany Region, 35000
Aude MERDRIGNAC, aude.merdrignac@chu-rennes.fr
Aude MERDRIGNAC
- Not yet recruiting
Hia Begin
Saint-Mandé, Île-de-France Region, 94160
Catherine ARIVEUX, 0443985242 ext. +33, catherine.arvieux@intradef.gouv.fr
Catherine ARVIEUX
- Recruiting
CHU de Saint-Etienne - Hôpital Nord
Saint-Priest-en-Jarez, Auvergne-Rhône-Alpes, 42270
Karine ABBOUD, karine.abboud@chu-st-etienne.fr
Karine ABBOUD
- Not yet recruiting
Clinique de l'Estrée
Stains, Île-de-France Region, 93240
Yamina LADJICI, 06 50 78 35 67 ext. +33, yladjici@gmail.com
Yamina LADJICI
- Recruiting
Hôpital d'Instruction des armées Sainte Anne - BCRM Toulon
Toulon, Provence-Alpes-Côte d'Azur Region, 83800
Stéphane BOURGOUIN, stephane_bourguoin@hotmail.fr
Stéphane BOURGOUIN
- Not yet recruiting
CHU de Tours
Tours, Indre Et Loire, 37044
Anne LE TOUZE, 02 34 38 95 47 ext. +33, a.letouze@chu-tours.fr
Anne LE TOUZE
- Not yet recruiting
CH de Troyes
Troyes, Aube, 10000
Geoffrey LEDOUX, 03 25 49 49 76 ext. +33, geoffrey.ledoux@hcs-sante.fr
Geoffrey LEDOUX
- Recruiting
CH de Voiron
Voiron, Auvergne-Rhône-Alpes, 38500
Romain RIBOUD, 04 76 15 62 15 ext. +33, rriboud1@chu-grenoble.fr
Romain RIBOUD
Reunion2 sites, 2 recruiting
- Recruiting
CHU de La Réunion
Saint-Denis, La Réunion, 97400
Radwan KASSIR, radwan.kassir@chu-reunion.fr
Radwan KASSIR
- Recruiting
CHU de La Réunion
Saint-Pierre, La Réunion, 97448
Johanna ZEMOUR, johanna.zemour@chu-reunion.fr
Johanna ZEMOUR
About this study
The potential benefit of outpatient care for this common digestive emergency is considerable, both for the patients themselves and for the public health system:
- 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.
- Improved patient satisfaction compared to waiting for hours in the emergency department due to lack of hospital beds.
- Non-inferiority of care in an outpatient unit in terms of quality and safety in day hospitalization.
- Significant decrease in the overall cost of this pathology as a result of a reduction in the hospital stay.
- Conditions
- Appendicitis
- Being tested
- Ambulatory appendectomy, Conventional appendectomy
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambulatory appendectomyProcedure or surgery
Appendectomy will be performed in outpatient surgery unit. Patient will be discharge from the hospital the same day as surgery
Conventional appendectomyProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Ambulatory pathway | Experimental | Not described Receives: Procedure: Ambulatory appendectomy |
| Conventional hospitalisation | Active comparator | Not described Receives: Procedure: Conventional appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days post surgery
Secondary outcomes (16)
To compare between both groups, at post-operative day 30, the delay from diagnosis to appendectomy
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.
Measured: 30 days post surgery
To compare between both groups, at post-operative day 30, the real cumulated length of hospitalization
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.
Measured: 30 days post surgery
To compare between both groups, at post-operative day 30, the rehospitalization rate
All re-hospitalization(s) after initial discharge will be counted until 30 days post surgery, whatever the cause or type of hospitalization.
Measured: 30 days post surgery
To compare between both groups, the mild morbidity (Clavien-Dindo I-II) during 30 days 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).
Measured: 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
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).
Measured: up to the 30th day post surgery
To compare between both groups, the rate of interventional radiology re-intervention (radio-guided drainage)
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.
Measured: up to the 30th day post surgery
To compare between both groups, the rate of laparoscopic re-intervention
All laparoscopic re-interventions performed in relation with the appendectomy and the potential complications will be recorded up to the 30th day post surgery.
Measured: up to the 30th day post surgery
To compare between both groups, at post-operative day 30, the rate of re-intervention by laparotomy
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.
Measured: up to the 30th day post surgery
To compare between both groups, patient satisfaction 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)?
Measured: 7 and 30 days post surgery
To compare between both groups, patient quality of life 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.
Measured: at inclusion and at 7 and 30 days post surgery
To evaluate the rate of conversion from outpatient to conventional care
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
Measured: up to the 30th day post surgery
To estimate the cost of outpatient appendectomy management
The cost will be estimated by the hospital cost (intervention and outpatient stay).
Measured: up to the 30th day post surgery
To study the economic impact (utility) of outpatient appendectomy management compared to conventional hospitalization
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.
Measured: up to the 30th day post surgery
To study the economic impact (effectiveness) of outpatient appendectomy management compared to conventional hospitalization
The economic impact will be studied with a cost-effectiveness analysis which will estimate the ICER in cost per patient without rehospitalization.
Measured: up to the 30th day post surgery
To study the generalization of outpatient appendectomy management in all French hospitals at the budgetary level
The generalization of outpatient appendectomy management will be studied with a budget impact model which will estimate the consequences in terms of costs
Measured: up to the 30th day post surgery
To study the generalization of outpatient appendectomy management in all French hospitals at a strategic level
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
Measured: up to the 30th day post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start17 Jul 2023
- Primary completion17 Jan 2028 (estimated)
- Study completion17 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05691348
- Sponsor's protocol ID
- 21-API-01
- Acronym
- SAMBA
- Status last verified
- Mar 2025
- First submitted
- 9 Jan 2023
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39252106
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Same Day Ambulatory Appendectomy (SAMBA)
- ClinicalTrials.gov ID
- NCT05691348
- Acronym / sponsor ID
- SAMBA / 21-API-01
- Conditions
- Appendicitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 17 Jan 2028 (estimated)
- Study completion
- 17 Jan 2028 (estimated)
- First posted
- 20 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The potential benefit of outpatient care for this common digestive emergency is considerable, both for the patients themselves and for the public health system:
- 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.
- Improved patient satisfaction compared to waiting for hours in the emergency department due to lack of hospital beds.
- Non-inferiority of care in an outpatient unit in terms of quality and safety in day hospitalization.
- Significant decrease in the overall cost of this pathology as a result of a reduction in the hospital stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ambulatory pathway | Experimental | Procedure: Ambulatory appendectomy |
| Conventional hospitalisation | Active comparator | Procedure: Conventional appendectomy |
Who may qualify
- Ages
- 15 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (18 listed)
- Patients aged 15-74 years
- BMI ≤ 35 kg/m2
- Uncomplicated acute appendicitis confirmed by imaging (ultrasound and/or CT and/or MRI)
- If pain, calmed by level 3 analgesic at maximum
- Ambulatory criteria
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ambulatory appendectomyAppendectomy will be performed in outpatient surgery unit. Patient will be discharge from the hospital the same day as surgery | Procedure or surgery | Ambulatory pathway |
| Conventional appendectomyAppendectomy 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 | Procedure or surgery | Conventional hospitalisation |
Primary outcome
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.
16 secondary outcomes
To compare between both groups, at post-operative day 30, the delay from diagnosis to appendectomy
Time frame: 30 days post surgery
To compare between both groups, at post-operative day 30, the real cumulated length of hospitalization
Time frame: 30 days post surgery
To compare between both groups, at post-operative day 30, the rehospitalization rate
Time frame: 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
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
To compare between both groups, the rate of interventional radiology re-intervention (radio-guided drainage)
Time frame: 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
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
To compare between both groups, patient satisfaction 7 and 30 days post surgery
Time frame: 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
To evaluate the rate of conversion from outpatient to conventional care
Time frame: up to the 30th day post surgery
To estimate the cost of outpatient appendectomy management
Time frame: 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
To study the economic impact (effectiveness) of outpatient appendectomy management compared to conventional hospitalization
Time frame: 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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Derived from this study: PubMed 39252106Arvieux 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
33 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ambulatory appendectomy and Conventional appendectomy in people with Appendicitis, run by Centre Hospitalier Universitaire de Nice at 33 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in France, Reunion. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Catherine ARVIEUX (04 43 98 52 42 ext. +33, catherine.arvieux@intradef.gouv.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05691348, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.