Same Day Ambulatory Appendectomy (SAMBA)

Appendicitis Clinical Trial

— SAMBA  

Official title:

Same Day Ambulatory Appendectomy (SAMBA)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05691348
• Other study ID #: 21-API-01
• Status: Recruiting
• Phase: N/A
• Start date: July 17, 2023
• Est. completion date: February 2026

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Catherine ARVIEUX
• Phone: 04 43 98 52 42
• Email: catherine.arvieux[@]intradef.gouv.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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) 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1400
• Est. completion date: February 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 74 Years

Eligibility

Inclusion Criteria:

• Patients aged 15-74 years

• BMI = 30 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 = 15,000G/L AND

• CRP (C reactive protein) = 50mg/L

• If pain, calmed by level 2 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 ß-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

Related Conditions & MeSH terms

• Appendicitis

Intervention

Procedure:
• Ambulatory appendectomy
Appendectomy will be performed in outpatient surgery unit. Patient will be discharge from the hospital the same day as surgery
• 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

Locations

Country	Name	City	State
France	CHU Amiens-Picardie	Amiens	Hauts-de-France
France	CHU d'Angers	Angers	Pays De La Loire
France	CHU Minjo	Besançon	Bourgogne-Franche-Comté
France	Clinique de Saint-Omer	Blendecques	Hauts-de-France
France	Hôpital Avicenne	Bobigny	Île-de-France
France	CHU de Bordeaux	Bordeaux	Aquitaine
France	HIA Percy	Clamart	Hauts-de-Seine
France	Hôpital Beaujon (APHP)	Clichy	Hauts De Seine
France	Hôpital Louis-Mourier	Colombes	Île-de-France
France	CH de Dax	Dax	Nouvelle-Aquitaine
France	Clinique du Val d'Ouest	Ecully	Rhones-Alpes
France	CHU Grenoble Alpes	La Tronche	Auvergne-Rhône-Alpes
France	Hôpital Edouard HERRIOT	Lyon	Auvergne-Rhône-Alpes
France	APHM Hôpital Nord	Marseille	Bouches-du-Rhône
France	Hôpital d'Instruction des armées Laveran	Marseille	Provence-Alpes-Côte d'Azur
France	CH de Mont de Marsan	Mont-de-Marsan	Nouvelle-Aquitaine
France	CHU de Nice	Nice	Alpes-Maritimes
France	Hôpitaux Pédiatriques de Nice CHU - Lenval	Nice	Alpes Maritimes
France	APHP Lariboisière	Paris	Ile De France
France	APHP Pitié Salpetrière	Paris	Ile De France
France	Hôpital Cochin APHP	Paris
France	CHU de Reims	Reims	Marne
France	Hôpital Robert Debré - CHU de Reims	Reims	Grand Est
France	CHU de Rennes	Rennes	Bretagne
France	Hia Begin	Saint-Mandé	Île-de-France
France	CHU de Saint-Etienne - Hôpital Nord	Saint-Priest-en-Jarez	Auvergne-Rhône-Alpes
France	Clinique de l'Estrée	Stains	Ile De France
France	Hôpital d'Instruction des armées Sainte Anne - BCRM Toulon	Toulon	Provence-Alpes-Côte d'Azur
France	CHU de Tours	Tours	Indre Et Loire
France	CH de Troyes	Troyes	Aube
France	CH de Voiron	Voiron	Auvergne-Rhône-Alpes
Réunion	CHU de La Réunion	Saint-Denis	La Réunion
Réunion	CHU de La Réunion	Saint-Pierre	La Réunion

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Countries where clinical trial is conducted

France,  Réunion, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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