About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Planned minimally invasive (laparoscopic or robot-assisted) CRS
No epidural analgesia
No new stoma
Bleeding < 500 ml
Disqualifiers
Patients who cannot comply with self-assessment
Improficiency in Danish
Pregnancy
Conversion to emergency surgery (uncontrolled perforation of bowel, ileus)
Trial design
Single group
Treatments tested in this trial
virtual Hospital at Home
Other interventiontelemedicine set-up, virtual Hospital at Home
Treatment groups
Trial outcomes
Primary outcomes
Number of recruited participants
Recruitment success is defined as 50% of eligible patients
Secondary outcomes
Number of drop-out participants
retention success is defined by less than 10% drop-outs
Number of protocol deviations
Percentage of: Planned daily video supported ward rounds provided adherence (successful adherence is defined by 95%) Planned self-measurements transmitted by patient adherence (successful adherence is defined by 80%)
Other outcomes
Patient related endpoints (surgical complications)
Clavien-Dindo classification: * Grade I: Minor complications that do not require specific treatment (e.g., antiemetics, antipyretics). * Grade II: Complications requiring pharmacological treatment (e.g., antibiotics, blood transfusions). * Grade III: Complications requiring surgical, endoscopic, or radiological intervention. * IIIa: Without general anesthesia. * IIIb: With general anesthesia. * Grade IV: Life-threatening complications requiring intensive care. * IVa: Single organ dysfunction. * IVb: Multi-organ dysfunction.
Patient related endpoints (readmittance rate)
Number of readmittances post discharge
Patient related endpoints (Mortality)
Mortality (associated)
Patient related endpoints (Quality of recovery)
Quality of Recovery-15 (QoR-15) is a short, patient-centered questionnaire designed to assess the quality of recovery after surgery. It is a streamlined version of the longer QoR-40 and includes 15 items that cover five key dimensions of recovery: 1. Physical Comfort 2. Emotional State 3. Psychological Support 4. Physical Independence 5. Pain Scoring: Each item is rated on a scale from 0 to 10, with higher scores indicating better recovery. The total score ranges from 0 to 150
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: