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.
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
- Conditions the study is for
- Colo-rectal Cancer, Colo-rectal Surgery, Colocolic and Ileocolic Anastomosis
- 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.
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
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).
- Conditions
- Colo-rectal Cancer, Colo-rectal Surgery, Colocolic and Ileocolic Anastomosis, Colon and/or Rectal Resection With Anastomosis for Cancer, Diverticular Disease of Colon, Colon Benign Tumor
- 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 group | Role | What they receive |
|---|---|---|
| virtual Hospital at Home | Experimental | participants 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.
Number of recruited participants
Recruitment success is defined as 50% of eligible patients
Measured: one year
Secondary outcomes (2)
Number of drop-out participants
retention success is defined by less than 10% drop-outs
Measured: one year
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.
- First posted11 Aug 2025
- Study start15 Dec 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colo-rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristin Julia Steinthorsdottir, Nordsjaellands Hospital
- Investigators
- Kristin J Steinthorsdottir, MD, Ph.d., Principal investigator, Nordsjaellands Hospital, Surgical Department
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 36697356Nikmanesh 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 39587580Gustafsson 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07113717
- Acronym / sponsor ID
- POPHaH / 100100100
- Conditions
- Colo-rectal Cancer, Colo-rectal Surgery, Colocolic and Ileocolic Anastomosis, Colon and/or Rectal Resection With Anastomosis for Cancer, Diverticular Disease of Colon, Colon Benign Tumor
- Keywords
- hospital at home for colorectal surgery, postoperative hospital at home
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility study
| Arm | Type | Receives |
|---|---|---|
| virtual Hospital at Home | Experimental | Other: virtual Hospital at Homeparticipants admittet to virtual Hospital at Home |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Planned minimally invasive (laparoscopic or robot-assisted) CRS
- No epidural analgesia
- No new stoma
- Bleeding < 500 ml
- Actual condition assessed to be clinically stable
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| virtual Hospital at Hometelemedicine set-up, virtual Hospital at Home | Other | virtual Hospital at Home |
Primary outcome
Number of recruited participants
Time frame: one year
Recruitment success is defined as 50% of eligible patients
2 secondary outcomes
Number of drop-out participants
Time frame: one year
Number of protocol deviations
Time frame: one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Background: PubMed 36697356Vu 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.
- Background: PubMed 39587580Nikmanesh 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.
- Background: PubMed 23099039Gustafsson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kristin J Steinthorsdottir, MD, Ph.d. principal investigator
Nordsjaellands Hospital, Surgical Department
1 site in 1 country: see every site and its status.
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; AzTrials last refreshed its copy on 7 Nov 2026.