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Colo-rectal CancerPOPHaHNCT07113717

Post Operative Hospital at Home After Colorectal Surgery

A study testing virtual Hospital at Home in people with Colo-rectal Cancer and Colo-rectal Surgery, run by Nordsjaellands Hospital at 1 site in Denmark.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
virtual Hospital at Home
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteDenmark
Study dates
15 Dec 2025to Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kristin J Steinthorsdottir, MD, Ph.d. contact

004531666112

kjs@dadlnet.dk

Claus A Bertelsen, MD, Ph.d. contact

004551906303

cabertelsen@gmail.com

Denmark1 site
  • Department of Surgery

    Hillerød, 3400

    Kristin J Steinthorsdottir, MD, Ph.d., 004531666112, kjs@dadlnet.dk

    Claus A Bertelsen, MD, Ph.d., 004551906303, cabertelsen@gmail.com

Other trials in Denmark

About this study

Official 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

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.

Read the detailed description

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).

Being tested
virtual Hospital at Home
Keywords
hospital at home for colorectal surgery, postoperative hospital at home
Medical subject headings
Colonic Neoplasms, Diverticulosis, Colonic, Crohn Disease, Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • virtual Hospital at HomeOther

    telemedicine set-up, virtual Hospital at Home

Study groups in NCT07113717
Study groupRoleWhat they receive
virtual Hospital at HomeExperimentalparticipants admittet to virtual Hospital at Home
Receives: Other: virtual Hospital at Home

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of recruited participants

    Recruitment success is defined as 50% of eligible patients

    Measured: one year

Secondary outcomes (2)
  1. Number of drop-out participants

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

    Measured: 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%)

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2025
  2. Study start15 Dec 2025 (estimated)
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
Feasibility study
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07113717
Sponsor's protocol ID
100100100
Acronym
POPHaH
Status last verified
Aug 2025
First submitted
7 Jul 2025
Last updated
11 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Vu MM, Curfman KR, Blair GE, Shah CA, Rashidi L. Beyond enhanced recovery after surgery (ERAS): Evolving minimally invasive colectomy from multi-day admissions to same-day discharge. Am J Surg. 2023 May;225(5):826-831. doi: 10.1016/j.amjsurg.2023.01.024. Epub 2023 Jan 21.

    PubMed 36697356
  • Nikmanesh P, Arabloo J, Gorji HA. Dimensions and components of hospital-at-home care: a systematic review. BMC Health Serv Res. 2024 Nov 25;24(1):1458. doi: 10.1186/s12913-024-11970-5.

    PubMed 39587580
  • Gustafsson UO, Scott MJ, Schwenk W, Demartines N, Roulin D, Francis N, McNaught CE, MacFie J, Liberman AS, Soop M, Hill A, Kennedy RH, Lobo DN, Fearon K, Ljungqvist O; Enhanced Recovery After Surgery Society. Guidelines for perioperative care in elective colonic surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Clin Nutr. 2012 Dec;31(6):783-800. doi: 10.1016/j.clnu.2012.08.013. Epub 2012 Sep 28.

    PubMed 23099039

Questions about this trial

What is this clinical trial studying?

A study testing virtual Hospital at Home in people with Colo-rectal Cancer and Colo-rectal Surgery, run by Nordsjaellands Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kristin J Steinthorsdottir, MD, Ph.d. (004531666112, kjs@dadlnet.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of recruited participants (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07113717, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.

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