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Same Day Ambulatory Appendectomy (SAMBA) (SAMBA)

Primary Purpose

Appendicitis

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Ambulatory appendectomy
Conventional appendectomy
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Appendicitis

Eligibility Criteria

15 Years - 74 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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

Sites / Locations

  • CHU de NiceRecruiting
  • CHU de Bordeaux
  • CHU Grenoble AlpesRecruiting
  • Hôpital Edouard HERRIOT
  • CHU de Saint-Etienne - Hôpital Nord
  • CH de Voiron
  • APHM Hôpital Nord
  • CHU Minjo
  • CHU de Rennes
  • Hôpital Robert Debré - CHU de Reims
  • CHU Amiens-PicardieRecruiting
  • Clinique de Saint-Omer
  • HIA Percy
  • APHP Pitié Salpetrière
  • APHP Lariboisière
  • Clinique de l'Estrée
  • CH de Dax
  • CH de Mont de Marsan
  • CHU d'AngersRecruiting
  • Hôpital d'Instruction des armées Laveran
  • Hôpital d'Instruction des armées Sainte Anne - BCRM ToulonRecruiting
  • Clinique du Val d'Ouest
  • Hôpital Avicenne
  • Hôpital Louis-Mourier
  • Hia Begin
  • CHU de La Réunion
  • CHU de La Réunion

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ambulatory pathway

Conventional hospitalisation

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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).
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).
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.
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.
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.
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)?
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.
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
To estimate the cost of outpatient appendectomy management
The cost will be estimated by the hospital cost (intervention and outpatient stay).
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.
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.
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
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

Full Information

First Posted
January 9, 2023
Last Updated
August 2, 2023
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT05691348
Brief Title
Same Day Ambulatory Appendectomy (SAMBA)
Acronym
SAMBA
Official Title
Same Day Ambulatory Appendectomy (SAMBA)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 17, 2023 (Actual)
Primary Completion Date
February 2026 (Anticipated)
Study Completion Date
February 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ambulatory pathway
Arm Type
Experimental
Arm Title
Conventional hospitalisation
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Ambulatory appendectomy
Intervention Description
Appendectomy will be performed in outpatient surgery unit. Patient will be discharge from the hospital the same day as surgery
Intervention Type
Procedure
Intervention Name(s)
Conventional appendectomy
Intervention Description
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
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
30 days post surgery
Secondary Outcome Measure Information:
Title
To compare between both groups, at post-operative day 30, the delay from diagnosis to appendectomy
Description
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.
Time Frame
30 days post surgery
Title
To compare between both groups, at post-operative day 30, the real cumulated length of hospitalization
Description
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.
Time Frame
30 days post surgery
Title
To compare between both groups, at post-operative day 30, the rehospitalization rate
Description
All re-hospitalization(s) after initial discharge will be counted until 30 days post surgery, whatever the cause or type of hospitalization.
Time Frame
30 days post surgery
Title
To compare between both groups, the mild morbidity (Clavien-Dindo I-II) during 30 days post surgery
Description
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).
Time Frame
up to the 30th day post surgery
Title
To compare between both groups, the severe morbidity (Clavien-Dindo III, IV, V) during 30 days post surgery
Description
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).
Time Frame
up to the 30th day post surgery
Title
To compare between both groups, the rate of interventional radiology re-intervention (radio-guided drainage)
Description
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.
Time Frame
up to the 30th day post surgery
Title
To compare between both groups, the rate of laparoscopic re-intervention
Description
All laparoscopic re-interventions performed in relation with the appendectomy and the potential complications will be recorded up to the 30th day post surgery.
Time Frame
up to the 30th day post surgery
Title
To compare between both groups, at post-operative day 30, the rate of re-intervention by laparotomy
Description
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.
Time Frame
up to the 30th day post surgery
Title
To compare between both groups, patient satisfaction 7 and 30 days post surgery
Description
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)?
Time Frame
7 and 30 days post surgery
Title
To compare between both groups, patient quality of life 7 and 30 days post surgery
Description
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.
Time Frame
at inclusion and at 7 and 30 days post surgery
Title
To evaluate the rate of conversion from outpatient to conventional care
Description
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
Time Frame
up to the 30th day post surgery
Title
To estimate the cost of outpatient appendectomy management
Description
The cost will be estimated by the hospital cost (intervention and outpatient stay).
Time Frame
up to the 30th day post surgery
Title
To study the economic impact (utility) of outpatient appendectomy management compared to conventional hospitalization
Description
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.
Time Frame
up to the 30th day post surgery
Title
To study the economic impact (effectiveness) of outpatient appendectomy management compared to conventional hospitalization
Description
The economic impact will be studied with a cost-effectiveness analysis which will estimate the ICER in cost per patient without rehospitalization.
Time Frame
up to the 30th day post surgery
Title
To study the generalization of outpatient appendectomy management in all French hospitals at the budgetary level
Description
The generalization of outpatient appendectomy management will be studied with a budget impact model which will estimate the consequences in terms of costs
Time Frame
up to the 30th day post surgery
Title
To study the generalization of outpatient appendectomy management in all French hospitals at a strategic level
Description
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
Time Frame
up to the 30th day post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine ARVIEUX
Phone
04 43 98 52 42
Ext
+33
Email
catherine.arvieux@intradef.gouv.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Damien MASSALOU
Phone
04 92 03 33 13
Ext
+33
Email
massalou.d@chu-nice.Fr
Facility Information:
Facility Name
CHU de Nice
City
Nice
State/Province
Alpes-Maritimes
ZIP/Postal Code
06000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Damien MASSALOU
Phone
0492033313
Ext
+33
Email
massalou.d@chu-nice.Fr
First Name & Middle Initial & Last Name & Degree
Damien MASSALOU
Facility Name
CHU de Bordeaux
City
Bordeaux
State/Province
Aquitaine
ZIP/Postal Code
33076
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent DUBUISSON
Phone
05 56 79 56 79
Ext
+33
Email
vincent.dubuisson@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Vincent DUBUISSON
Facility Name
CHU Grenoble Alpes
City
La Tronche
State/Province
Auvergne-Rhône-Alpes
ZIP/Postal Code
38700
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julio ABBA
Phone
06 63 68 33 94
Ext
+33
Email
JAbba@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
Julio ABBA
Facility Name
Hôpital Edouard HERRIOT
City
Lyon
State/Province
Auvergne-Rhône-Alpes
ZIP/Postal Code
69003
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier MONNEUSE
Phone
04 72 11 01 02
Ext
+33
Email
olivier.monneuse@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Olivier MONNEUSE
Facility Name
CHU de Saint-Etienne - Hôpital Nord
City
Saint-Priest-en-Jarez
State/Province
Auvergne-Rhône-Alpes
ZIP/Postal Code
42270
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karine ABBOUD
Email
karine.abboud@chu-st-etienne.fr
First Name & Middle Initial & Last Name & Degree
Karine ABBOUD
Facility Name
CH de Voiron
City
Voiron
State/Province
Auvergne-Rhône-Alpes
ZIP/Postal Code
38500
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Romain RIBOUD
Phone
04 76 15 62 15
Ext
+33
Email
rriboud1@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
Romain RIBOUD
Facility Name
APHM Hôpital Nord
City
Marseille
State/Province
Bouches-du-Rhône
ZIP/Postal Code
13326
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura BEYER
Phone
04 91 96 50 90
Ext
+33
Email
laura.beyer@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
Laura BEYER
Facility Name
CHU Minjo
City
Besançon
State/Province
Bourgogne-Franche-Comté
ZIP/Postal Code
25000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Célia TURCO
Phone
03 81 66 83 22
Ext
+33
Email
cturco@chu-besancon.fr
First Name & Middle Initial & Last Name & Degree
Célia TURCO
Facility Name
CHU de Rennes
City
Rennes
State/Province
Bretagne
ZIP/Postal Code
35000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aude MERDRIGNAC
Email
aude.merdrignac@chu-rennes.fr
First Name & Middle Initial & Last Name & Degree
Aude MERDRIGNAC
Facility Name
Hôpital Robert Debré - CHU de Reims
City
Reims
State/Province
Grand Est
ZIP/Postal Code
51092
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rami RHAIEM
Phone
03 26 78 70 79
Ext
+33
Email
rrhaiem@chu-reims.fr
First Name & Middle Initial & Last Name & Degree
Rami RHAIEM
Facility Name
CHU Amiens-Picardie
City
Amiens
State/Province
Hauts-de-France
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elodie HARAUX
Phone
06 61 78 41 15
Ext
+33
Email
haraux.elodie@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
Elodie HARAUX
Facility Name
Clinique de Saint-Omer
City
Blendecques
State/Province
Hauts-de-France
ZIP/Postal Code
62575
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
André DABROWSKI
Email
a.dabrowski@free.fr
First Name & Middle Initial & Last Name & Degree
André DABROWSKI
Facility Name
HIA Percy
City
Clamart
State/Province
Hauts-de-Seine
ZIP/Postal Code
92140
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuel HORNEZ
Phone
01 41 46 61 67
Ext
+33
Email
emmanuelhornez@gmail.com
First Name & Middle Initial & Last Name & Degree
Emmanuel HORNEZ
Facility Name
APHP Pitié Salpetrière
City
Paris
State/Province
Ile De France
ZIP/Postal Code
75013
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sébastien GAUJOUX
Phone
01 58 41 50 09
Ext
+33
Email
sebastien.gaujoux@aphp.fr
First Name & Middle Initial & Last Name & Degree
Sébastien GAUJOUX
Facility Name
APHP Lariboisière
City
Paris
State/Province
Ile De France
ZIP/Postal Code
75475
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karine PAUTRAT
Email
karine.pautrat@aphp.fr
First Name & Middle Initial & Last Name & Degree
Karine PAUTRAT
Facility Name
Clinique de l'Estrée
City
Stains
State/Province
Ile De France
ZIP/Postal Code
93240
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yamina LADJICI
Phone
06 50 78 35 67
Ext
+33
Email
yladjici@gmail.com
First Name & Middle Initial & Last Name & Degree
Yamina LADJICI
Facility Name
CH de Dax
City
Dax
State/Province
Nouvelle-Aquitaine
ZIP/Postal Code
40107
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin BLANC
Phone
05 58 91 66 43
Email
blancb@ch-dax.fr
First Name & Middle Initial & Last Name & Degree
Benjamin BLANC
Facility Name
CH de Mont de Marsan
City
Mont-de-Marsan
State/Province
Nouvelle-Aquitaine
ZIP/Postal Code
40000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rémy CHEVALIER
Phone
05 58 05 11 28
Ext
+33
Email
remy.chevalier@ch-mdm.fr
First Name & Middle Initial & Last Name & Degree
Rémy CHEVALIER
Facility Name
CHU d'Angers
City
Angers
State/Province
Pays De La Loire
ZIP/Postal Code
49933
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emilie LERMITE
Phone
02 41 35 36 18
Ext
+33
First Name & Middle Initial & Last Name & Degree
elermite@chu-angers.fr
First Name & Middle Initial & Last Name & Degree
Emilie LERMITE
Facility Name
Hôpital d'Instruction des armées Laveran
City
Marseille
State/Province
Provence-Alpes-Côte d'Azur
ZIP/Postal Code
13384
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yvain GOUDARD
Phone
04 91 61 73 21
Ext
+33
Email
ygoudard.laveran@gmail.com
First Name & Middle Initial & Last Name & Degree
Yvain GOUDARD
Facility Name
Hôpital d'Instruction des armées Sainte Anne - BCRM Toulon
City
Toulon
State/Province
Provence-Alpes-Côte d'Azur
ZIP/Postal Code
83800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphane BOURGOUIN
Email
stephane_bourguoin@hotmail.fr
First Name & Middle Initial & Last Name & Degree
Stéphane BOURGOUIN
Facility Name
Clinique du Val d'Ouest
City
Ecully
State/Province
Rhones-Alpes
ZIP/Postal Code
69130
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe GUILLEM
Phone
04 72 19 31 75
Ext
+33
Email
docteurphguillem@outlook.com
First Name & Middle Initial & Last Name & Degree
Philippe GUILLEM
Facility Name
Hôpital Avicenne
City
Bobigny
State/Province
Île-de-France
ZIP/Postal Code
93000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe TRESALLET
Phone
01 48 02 61 95
Ext
+33
Email
christophe.tresallet@aphp.fr
First Name & Middle Initial & Last Name & Degree
Christophe TRESALLET
Facility Name
Hôpital Louis-Mourier
City
Colombes
State/Province
Île-de-France
ZIP/Postal Code
92700
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David MOSZKOWICZ
Email
david.moszkowicz@aphp.fr
First Name & Middle Initial & Last Name & Degree
David MOSZKOWICZ
Facility Name
Hia Begin
City
Saint-Mandé
State/Province
Île-de-France
ZIP/Postal Code
94160
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine ARIVEUX
Phone
0443985242
Ext
+33
Email
catherine.arvieux@intradef.gouv.fr
First Name & Middle Initial & Last Name & Degree
Catherine ARVIEUX
Facility Name
CHU de La Réunion
City
Saint-Denis
State/Province
La Réunion
ZIP/Postal Code
97400
Country
Réunion
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Radwan KASSIR
Email
radwan.kassir@chu-reunion.fr
First Name & Middle Initial & Last Name & Degree
Radwan KASSIR
Facility Name
CHU de La Réunion
City
Saint-Pierre
State/Province
La Réunion
ZIP/Postal Code
97448
Country
Réunion
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johanna ZEMOUR
Email
johanna.zemour@chu-reunion.fr
First Name & Middle Initial & Last Name & Degree
Johanna ZEMOUR

12. IPD Sharing Statement

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