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NCT Number: NCT07113717

Post Operative Hospital at Home After Colorectal Surgery

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.

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Key information

About this study

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) .

The key question and original premise for ERAS is: "Why is the patient still in hospital" (5) . With the technical advancements and necessity brought on by the COVID-19 pandemic, a platform for virtual Hospital at Home (vHaH) was founded. Initially started as an admission-avoidance strategy for patients with acute medical conditions the concept evolved into an 'early discharge' hospital at home model and has been implemented by some elective surgical specialities (primarily orthopaedic) (9-10) .

CRS centres across the USA and Europe have been implementing Virtual Hospital or Same-Day discharge (SDD) for selected patients for the last couple of years (11-16) . Retrospective reviews and analyses of data, although inherently biased, have so far shown non-inferiority and suggested superiority regarding patient experience and safety ( 17-21) . A newly published pilot study on remote monitoring after CRC in rural areas showed feasibility and high patient acceptance ( 22) . However, there seem to be unreported barriers to generalized implementation. So far, there is only very limited documented surgical experience from sound research approaches available in the literature. This surgical feasibility study builds on methods previously tested in a medical population at the investigators' institution ( 23) . The findings will inform the development and design of a randomized clinical trial to evaluate the final telemedicine-supported vHaH model for surgical patients.

The overall aim of POPHaH is to implement a telemedicine monitoring and communication model that will enable the safe admission of postoperative patients in their homes.

A hospital based Virtual Surgical Centre (VSC) will be located in the Department of Surgery at Copenhagen University Hospital - North Zealand (NOH), from where medical staff will monitor and communicate with patients admitted at home. Vital parameters and patient-reported outcomes will be collected using a smartphone/tablet-based app. All data will be collected and displayed in real-time at the NOH in the VSC, allowing medical staff to monitor the vHaH patients similarly to in-patients. In addition, daily virtual ward rounds conducted by staff in the VSC and, when relevant, by medical doctors (MDs) from specialities relevant to the patients' illness(es) will ensure close communication and relevant clinical assessments.

This vHaH model is expected to become an integrated part of the hospital postoperative observation repertoire in the Capital Region of Denmark and elsewhere. In this feasibility study, hospitalized patients with surgical conditions will be offered the opportunity to continue their hospital course as a home-based admission.

Study Purpose

The objective of this feasibility study is to investigate and analyze the key factors involved in admitting adult patients undergoing CRS, including cancer surgery, in a vHaH model. The study aims to evaluate the likelihood of successfully completing the vHaH model in this patient group.

It will focus on assessing outcomes related to patients, their next of kin, clinical aspects and organizational dynamics. Additionally, it will examine factors crucial for determining the feasibility of conducting a full-scale randomized controlled trial.

Research Question

What are the patient- and next-of-kin-related effects, as well as the clinical and organisational effects, of home-based admission? What are the implementation barriers for a full-scale randomized controlled trial?

Hypothesis

The investigators hypothesize that early postoperative discharge of selected CRS patients to a telemedicine-supported vHaH model, will be a viable alternative to conventional hospitalization without compromising patient and next-of-kin safety or satisfaction.

Rationale

Virtual Hospital-at-Home (vHaH) following CRS offers numerous advantages. For patients, it promotes a faster return to normal life, encourages postoperative mobilization, reduces the risk of hospital-acquired infections, and allows recovery in the comfort of their own homes with family support. On a societal level, vHaH presents an opportunity to optimize healthcare resources, and addresses challenges posed by centralization and an aging population.

Over the past two decades, the Danish public healthcare system has undergone significant centralization, resulting in fewer, larger hospitals with a reduced bed capacity at both regional and national levels. At the same time, the aging population and increasing prevalence of multimorbidity have placed additional demands on the system. Prioritizing hospital beds without compromising the quality of care is crucial.

Enhanced Recovery After Surgery (ERAS) pathways have demonstrated that postoperative recovery can be efficient and safe within hospitals. Combining ERAS principles with vHaH models, supported by research on patient safety and satisfaction, enables same-day or next-day discharge to a vHaH after CRS for selected patients.

Given that ERAS pathways were originally designed for CRS, and with nearly two decades of experience in this field, together with the clinical and scientific experience from the medical colleagues in the Department of Pulmonology and Infectious Diseases at the investigators' institution, this surgical department is uniquely positioned to pilot the model. Successfully implementing a surgical vHaH program in this patient group could serve as a blueprint for expanding the approach to other abdominal surgical subspecialities and surgical specialities, further enhancing healthcare delivery across the board. The investigators are conducting a feasibility study to thoroughly examine potential barriers to implementing surgical vHaH, including logistical challenges and patient acceptance. This approach is designed to ensure the model's sustainability and adaptability for broader application. Following this, the investigators plan to evaluate its effectiveness through a randomized controlled trial (RCT).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

virtual Hospital at Home

Other

telemedicine set-up, virtual Hospital at Home

Primary outcomes

  1. Number of recruited participants

    Time frame: one year

    Recruitment success is defined as 50% of eligible patients

Secondary outcomes

  1. Number of drop-out participants

    Time frame: one year

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

  2. Number of protocol deviations

    Time frame: one year

    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

  1. Patient related endpoints (surgical complications)

    Time frame: Thirty days after surgery

    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.
  2. Patient related endpoints (readmittance rate)

    Time frame: Thirty days after surgery

    Number of readmittances post discharge

  3. Patient related endpoints (Mortality)

    Time frame: Thirty days after surgery

    Mortality (associated)

  4. Patient related endpoints (Quality of recovery)

    Time frame: Thirty days after surgery

    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:

    • Physical Comfort
    • Emotional State
    • Psychological Support
    • Physical Independence
    • 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
  5. Patient related endpoints (Hours out of bed)

    Time frame: From discharge from post-operative care unit to discharge from home-based admission (estimated 2-4 days, up to maximum 14 days). Measured in hours and minutes.

    Hours out of bed, measured by a SENS motion® accelerometric sensor, detailed data about number of steps.

  6. Patient related endpoint (Sleep)

    Time frame: From discharge from post-operative care unit to discharge from home-based admission (estimated 2-4 days, up to maximum 14 days). Measured in hours and minutes, per 24 hours.

    Lenght (in hours) of sleep, measured with SENS motion® accelerometric sensor

  7. Next-of-kin-related endpoints

    Time frame: one year

    Caregiver strain (primary informal caregivers will be invited to explorative interviews to establish factors of importance)

  8. Unscheduled contacts (including virtual)

    Time frame: From discharge from post-operative care unit to discharge from home-based admission (estimated 2-4 days, up to maximum 14 days). .

    Number of unscheduled contacts during admission

  9. Contacts to general practitioner

    Time frame: From discharge from post-operative care unit to discharge from home-based admission (estimated 2-4 days, up to maximum 14 days).

    Number of contacts to general practitioner during home-based admission

  10. Hours in-hospital

    Time frame: From discharge from post-operative care unit to discharge from home-based admission (estimated 2-4 days, up to maximum 14 days).

    Number of in-hospital hours

  11. Outpatient visits

    Time frame: From discharge until 30 days after surgery

    Number of outpatient visits

Study contacts

Contact information is provided by the study sponsor or research team.

Claus A Bertelsen, MD, Ph.d.

CONTACT

[email protected]

004551906303

Kristin J Steinthorsdottir, MD, Ph.d.

CONTACT

[email protected]

004531666112

Sponsors and collaborators

Lead sponsor

Nordsjaellands Hospital

Other

Registry information

Official study title

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

Acronym: POPHaH

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 11, 2025
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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