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The potential benefit of outpatient care for this common digestive emergency is considerable, both for the patients themselves and for the public health system:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ambulatory pathway | Experimental |
| |
| Conventional hospitalisation | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ambulatory appendectomy | Procedure | Appendectomy will be performed in outpatient surgery unit. Patient will be discharge from the hospital the same day as surgery |
|
| 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days post surgery |
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Inclusion Criteria:
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
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Catherine ARVIEUX | Contact | 04 43 98 52 42 | +33 | catherine.arvieux@intradef.gouv.fr |
| Damien MASSALOU | Contact | 04 92 03 33 13 | +33 | massalou.d@chu-nice.Fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpitaux Pédiatriques de Nice CHU - Lenval | Not yet recruiting | Nice | Alpes Maritimes | 06200 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39252106 | Derived | 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. |
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| 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 |
|
| 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. |
| 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. | 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). | 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). | 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. | 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. | 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. | 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)? | 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. | 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 | 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). | 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. | 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. | 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 | 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 | up to the 30th day post surgery |
| CHU de Nice | Recruiting | Nice | Alpes-Maritimes | 06000 | France |
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| CHU de Bordeaux | Not yet recruiting | Bordeaux | Aquitaine | 33076 | France |
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| CH de Troyes | Not yet recruiting | Troyes | Aube | 10000 | France |
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| CHU Grenoble Alpes | Recruiting | La Tronche | Auvergne-Rhône-Alpes | 38700 | France |
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| Hôpital Edouard HERRIOT | Recruiting | Lyon | Auvergne-Rhône-Alpes | 69003 | France |
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| CHU de Saint-Etienne - Hôpital Nord | Recruiting | Saint-Priest-en-Jarez | Auvergne-Rhône-Alpes | 42270 | France |
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| CH de Voiron | Recruiting | Voiron | Auvergne-Rhône-Alpes | 38500 | France |
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| APHM Hôpital Nord | Recruiting | Marseille | Bouches-du-Rhône | 13326 | France |
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| CHU Minjo | Not yet recruiting | Besançon | Bourgogne-Franche-Comté | 25000 | France |
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| CHU de Rennes | Not yet recruiting | Rennes | Brittany Region | 35000 | France |
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| Hôpital Robert Debré - CHU de Reims | Recruiting | Reims | Grand Est | 51092 | France |
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| Hôpital Beaujon (APHP) | Not yet recruiting | Clichy | Hauts de Seine | 92110 | France |
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| CHU Amiens-Picardie | Recruiting | Amiens | Hauts-de-France | 80054 | France |
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| Clinique de Saint-Omer | Not yet recruiting | Blendecques | Hauts-de-France | 62575 | France |
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| HIA Percy | Not yet recruiting | Clamart | Hauts-de-Seine | 92140 | France |
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| CHU de Tours | Not yet recruiting | Tours | Indre Et Loire | 37044 | France |
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| CHU de Reims | Not yet recruiting | Reims | Marne | 51100 | France |
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| CH de Dax | Recruiting | Dax | New Aquitaine | 40107 | France |
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| CH de Mont de Marsan | Recruiting | Mont-de-Marsan | New Aquitaine | 40000 | France |
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| Hôpital Cochin APHP | Not yet recruiting | Paris | Paris | 75014 | France |
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| CHU d'Angers | Recruiting | Angers | Pays de la Loire Region | 49933 | France |
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| Hôpital d'Instruction des armées Laveran | Recruiting | Marseille | Provence-Alpes-Côte d'Azur Region | 13384 | France |
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| Hôpital d'Instruction des armées Sainte Anne - BCRM Toulon | Recruiting | Toulon | Provence-Alpes-Côte d'Azur Region | 83800 | France |
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| Clinique du Val d'Ouest | Not yet recruiting | Écully | Rhones-Alpes | 69130 | France |
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| Hôpital Avicenne | Recruiting | Bobigny | Île-de-France Region | 93000 | France |
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| Hôpital Louis-Mourier | Not yet recruiting | Colombes | Île-de-France Region | 92700 | France |
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| APHP Pitié Salpetrière | Not yet recruiting | Paris | Île-de-France Region | 75013 | France |
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| APHP Lariboisière | Recruiting | Paris | Île-de-France Region | 75475 | France |
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| Hia Begin | Not yet recruiting | Saint-Mandé | Île-de-France Region | 94160 | France |
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| Clinique de l'Estrée | Not yet recruiting | Stains | Île-de-France Region | 93240 | France |
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| CHU de La Réunion | Recruiting | Saint-Denis | La Réunion | 97400 | Reunion |
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| CHU de La Réunion | Recruiting | Saint-Pierre | La Réunion | 97448 | Reunion |
|
| ID | Term |
|---|---|
| D001064 | Appendicitis |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |
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