Ignite Creation Date:
2024-07-17 @ 11:00 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06478810
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2022-10-31
Brief Title:
Ambulatory Surgery After Hepatectomy Monitoring by Domomedicine Connected Tools and a Dedicated Nurse
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Ambulatory Surgery After Hepatectomy Piloteasibility Study With Securing of the Post-operative Monitoring by Domomedicine Connected Tools and a Dedicated Nurse
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HEPADOM
Brief Summary:
There are public health expectations for the development of outpatient surgery and increased comfort and quality of care for the patient In this study we are interested in evaluating the feasibility of an outpatient hepatectomy with a a close and secure follow-up at home through a connected platform and a follow-up by a nurse The primary endpoint is the rate of re-hospitalization due to a postoperative complication before Day 30 and the rate of conversion to conventional hospitalization early failure of outpatient management This single-center study will includes prospectively 20 patients requiring liver resection of up to 2 segments The primary endpoint is the rate of re-hospitalization due to a postoperative complication before Day 30 and the rate of conversion to conventional hospitalization early failure of outpatient management
Detailed Description:
In response to public health expectations for the development of outpatient surgery ministerial authorities are now encouraging medical facilities to organize their care around this innovative care pathway Ambulatory surgery is gradually becoming one of the major objectives of any surgical service and many recommendations from the HAS Haute Autorité de Santé have recently become available to support and facilitate this transformation Ambulatory surgery is no longer limited to simple surgery but also concerns highly technical surgical procedures with safety conditions identical to those required during conventional hospitalization Therefore ambulatory surgery must to limit the risk of postoperative complications but in case of complications to do everything possible to manage them quickly and not to make the patient lose chances because of his geographical distance The main objective of this study is to evaluate the feasibility of a minor hepatectomy under laparoscopy during an ambulatory management This management will be made possible thanks to the integration of Domomedicine and dedicated nursing care for a close and secure monitoring The population is 20 major patients with an indication for laparoscopic surgery for peripheral benign or malignant liver tumor requiring liver resection of up to 2 segments The study lasts a maximum of 15 months 12 months of inclusion 1 month of patient follow-up and 1 month of prohibition from participating in another interventional study The study will proceed as described below Initial diagnosis of the liver disease Realization in primary care by a general practitioner or gastroenterologist or oncologist and realization of imaging in town
Confirmation of diagnosis and registration Surgical consultations and anesthesia consultation at the hospital and registration on the surgical staff list
Pre-selection visit
Pre-operative evaluation Inclusion visit Consultation by the surgeon and dedicated nurse
Surgical staff Collegial evaluation of the surgical file confirmation of the proposed surgical strategy
Preoperative follow-up Home visit 3 working days before the intervention Day -3 and telephone call 1 working day before the intervention Day -1 Dedicated nurse consultation Delivery of information and materials and information from stakeholders Family caregivers city IDE and attending physician
Hepatectomy Day 0 Outpatient intervention
Postoperative follow-up Day 1 to Day 7 Visit Day 30 Call to Day 1 by the dedicated nurse Follow-up by dedicated nurse of the data transmitted during the 7 days following the hepatectomy coupled with home follow-up by the PRADO nurse Co-Consultation dedicated nurse and surgeon on D7 and D30 end of follow-up as part of the research
Return of home medicine devices on Day 7 Report to attending physician
The expected benefits for the patient are
Limitation of infections associated with care nosocomial
Habits rhythm of life and family and social environment preserved thanks to the return home the same day
Potentially faster return to work
Reduction in the cost of hospitalization he expected benefits for the company
Optimization of the organization and resources of surgical technical platforms
Decongestion of hospitalization services
Sustainability of the health system thanks to shorter stays and therefore less expensive for the Health Insurance
Implementation of innovative protocols publications and potential notoriety The risks of the study are low the use of the platform will not replace existing uses but will provide new or additional information whose consistency is verified by the care team Post-operative follow-up will be equivalent in terms of the frequency of paramedical visits to conventional care hospitalization 1 day and a doctor will be contactable by the dedicated nurse 24 hours a day to organize if necessary a transfer to the emergency room or the Hepato-Biliary Center of the Paul Brousse Hospital
The use of the connected devices does not involve any specific risk because they are non-invasive sensors marketed and marked CE Regarding the postoperative risk of severe complications severe bleeding or severe sepsis this is low even very low 05 since we will only include minor hepatectomies In addition cirrhotic patients will not be included in this study
Confirmation of diagnosis and registration Surgical consultations and anesthesia consultation at the hospital and registration on the surgical staff list
Pre-selection visit
Pre-operative evaluation Inclusion visit Consultation by the surgeon and dedicated nurse
Surgical staff Collegial evaluation of the surgical file confirmation of the proposed surgical strategy
Preoperative follow-up Home visit 3 working days before the intervention Day -3 and telephone call 1 working day before the intervention Day -1 Dedicated nurse consultation Delivery of information and materials and information from stakeholders Family caregivers city IDE and attending physician
Hepatectomy Day 0 Outpatient intervention
Postoperative follow-up Day 1 to Day 7 Visit Day 30 Call to Day 1 by the dedicated nurse Follow-up by dedicated nurse of the data transmitted during the 7 days following the hepatectomy coupled with home follow-up by the PRADO nurse Co-Consultation dedicated nurse and surgeon on D7 and D30 end of follow-up as part of the research
Return of home medicine devices on Day 7 Report to attending physician
The expected benefits for the patient are
Limitation of infections associated with care nosocomial
Habits rhythm of life and family and social environment preserved thanks to the return home the same day
Potentially faster return to work
Reduction in the cost of hospitalization he expected benefits for the company
Optimization of the organization and resources of surgical technical platforms
Decongestion of hospitalization services
Sustainability of the health system thanks to shorter stays and therefore less expensive for the Health Insurance
Implementation of innovative protocols publications and potential notoriety The risks of the study are low the use of the platform will not replace existing uses but will provide new or additional information whose consistency is verified by the care team Post-operative follow-up will be equivalent in terms of the frequency of paramedical visits to conventional care hospitalization 1 day and a doctor will be contactable by the dedicated nurse 24 hours a day to organize if necessary a transfer to the emergency room or the Hepato-Biliary Center of the Paul Brousse Hospital
The use of the connected devices does not involve any specific risk because they are non-invasive sensors marketed and marked CE Regarding the postoperative risk of severe complications severe bleeding or severe sepsis this is low even very low 05 since we will only include minor hepatectomies In addition cirrhotic patients will not be included in this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-A03171-54 | OTHER | None | None |