跳至主要内容
临床试验/NCT06478810
NCT06478810尚未招募不适用

Ambulatory Surgery After Hepatectomy: Piloteasibility Study With Securing of the Post-operative Monitoring by Domomedicine Connected Tools and a Dedicated Nurse.

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
20
试验地点
1
主要终点
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).

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

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).

时间窗: Day 30

Rate of re-hospitalization due to a postoperative complication before Day 30 and the rate of conversion to conventional hospitalization.

次要结局

  • Evaluation of the rate of data collection in patients' homes outside of technical failure.(Day 30)
  • Severity of complications (Clavien classification)(From Day 0 to Day 30)
  • Mortality rate at Day 30(Day 30)
  • Morbidity rate at Day 30(Day 30)
  • Satisfaction of the ambulatory management.(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.)
  • Diagnosis of digestive complications(At Day -3, at Day 0, at Day 1 to Day 7 and at Day 30)
  • Type of complications(From Day 0 to Day 30)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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