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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A03171-54 | Other Identifier | ANSM |
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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).
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 AutoritĂ© de SantĂ©) 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)
Return of home medicine devices on Day 7 Report to attending physician.
The expected benefits for the patient are:
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 (<0.5%) since we will only include minor hepatectomies. In addition, cirrhotic patients will not be included in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ambulatory follow-up (Domomedicine and dedicated nursing care) after a minor Hepatectomy | Experimental | Actions added by the research :
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Domomedicine and dedicated nursing care for a close and secure monitoring after an ambulatory hepatectomy | Other | For patient who need a minor hepatectomy under laparoscopy for the standard of care, the follow-up will be an ambulatory follow-up. This ambulatory follow-up will be made possible thanks to the integration of Domomedicine and dedicated nursing care for a close and secure monitoring. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Rate of re-hospitalization due to a postoperative complication before Day 30 and the rate of conversion to conventional hospitalization. | Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the rate of data collection in patients' homes outside of technical failure. | Evaluation of the rate of data collection in patients' homes outside of technical failure. This will permits to appreciate the adherence to the ambulatory mode of care. | Day 30 |
| Diagnosis of digestive complications |
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Inclusion criteria : - Male or female, 18 to 69 years old
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicolas GOLSE | Contact | + 33 1 45 59 66 25 | nicolas.golse@aphp.fr | |
| René ADAM | Contact | + 33 1 45 59 64 09 | rene.adam@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Nicolas GOLSE | Hepato-biliary surgery department, Paul Brousse hospital, APHP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hepato-biliary surgery department | Villejuif | France |
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|
Digestive complicactions questionnaire, including transit, pain and feeding personnal feeling (internal scale) |
| At Day -3, at Day 0, at Day 1 to Day 7 and at Day 30 |
| Type of complications | Type of complications | From Day 0 to Day 30 |
| Severity of complications (Clavien classification) | Severity of complications following the Clavien classification | From Day 0 to Day 30 |
| Mortality rate at Day 30 | Mortality rate at Day 30 | Day 30 |
| Morbidity rate at Day 30 | CCI score (Comprehensive Complication Index) at Day 30 | Day 30 |
| Satisfaction of the ambulatory management. | Score based on three questionnaires completed by the patient : MDASI questionnaire, Quality of life questionnaire (SF36) and Satisfaction of the ambulatory medical support | MDASI questionnaire : at Day -3, at Day 0 and at Day 1 to Day 7 ; SF 36 questionnaire : Day -3 and at Day 30; Satisfaction of the ambulatory questionnaire at Day 30. |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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