Post Operative Hospital at Home After Colorectal Surgery

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNordsjaellands Hospital

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • virtual Hospital at Home

    Other intervention

    telemedicine set-up, virtual Hospital at Home

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: virtual Hospital at HomeExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of recruited participants

Recruitment success is defined as 50% of eligible patients

Time frame
one year

Secondary outcomes

1

Number of drop-out participants

retention success is defined by less than 10% drop-outs

Time frame
one year
2

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%)

Time frame
one year

Other outcomes

1

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.

Time frame
Thirty days after surgery
2

Patient related endpoints (readmittance rate)

Number of readmittances post discharge

Time frame
Thirty days after surgery
3

Patient related endpoints (Mortality)

Mortality (associated)

Time frame
Thirty days after surgery
4

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

Time frame
Thirty days after surgery

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: