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临床试验/NCT07113717
NCT07113717尚未招募不适用

Early Post-operative Discharge of Colorectal Surgical Patients to a Virtual Hospital at Home Model (Post Operative Hospital at Home) - a Clinical Feasibility Study

Nordsjaellands Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年12月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
Number of recruited participants

研究概览

简要总结

The goal of this feasibility study is to investigate whether a virtual Hospital at Home is safe and possible for patients undergoing planned minimally invasive colorectal surgery. The study aims to answer the following main questions:

What are the patient- and next-of-kin-related effects, as well as the clinical and organizational effects, of home-based admission? What are the implementation barriers for a full-scale randomized controlled trial? Participants will follow a standardized protocol for their care befor, during and after surgery. However, the care after surgery will be conducted at home using telemedicine.

详细描述

Original Title

Feasibility of Early Post-Operative Discharge to a Virtual Hospital at Home Model for Colorectal Surgical Patients.

Purpose

Project context

Enhanced recovery after surgery (ERAS) is an evidence-based approach designed to help patients recover more quickly and safely after surgery( 1) . It is widely implemented in many centres that offer minimally invasive colorectal surgery (CRS) (2,3) . This multimodal approach aims to reduce the physical and psychological stress of surgery, resulting in lower complication rates, shorter hospital stays, and reduced healthcare costs. Continuous efforts are made to implement and evaluate individual components of the ERAS protocol, ensuring that valuable aspects for patients and society are maintained and enhanced, while redundant elements are eliminated ( 1,4,5) . Optimizing all modifiable patient-related factors before surgery and adhering to standardized peri-operative care pathways is essential when striving to not only surgically remove a disease but also to ensure that patients are better off after surgery ( 6-8) .

研究设计

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

入排标准

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

入选标准

  • •Planned minimally invasive (laparoscopic or robot-assisted) CRS
  • •No epidural analgesia
  • •No new stoma
  • •Bleeding < 500 ml
  • •Actual condition assessed to be clinically stable
  • •Meeting the Chung score discharge criteria for ambulatory surgery
  • •Self-reliant or receives sufficient formal care to be care-independent of a primary informal caregiver
  • •Home-based admission will be located within catchment area of the hospital (according to the official address of the individual)
  • •Signed informed written and oral consent

排除标准

  • •Patients who cannot comply with self-assessment
  • •Improficiency in Danish
  • •Pregnancy
  • •Conversion to emergency surgery (uncontrolled perforation of bowel, ileus)
  • •Complications during surgery warranting in-hospital admission (observation in intensive care unit or close observation from other specialities, e.g. cardiology)

研究组 & 干预措施

virtual Hospital at Home

Experimental

participants admittet to virtual Hospital at Home

干预措施: virtual Hospital at Home (Other)

结局指标

主要结局

Number of recruited participants

时间窗: one year

Recruitment success is defined as 50% of eligible patients

次要结局

  • Number of protocol deviations(one year)
  • Number of drop-out participants(one year)

研究者

发起方
Nordsjaellands Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kristin Julia Steinthorsdottir

Surgeon, ph.d.

Nordsjaellands Hospital

研究点 (1)

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