Post Operative Hospital at Home After Colorectal Surgery

NCT07113717 | Not Yet Recruiting

• 1 other identifier: 100100100
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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; Crohn Disease and Ulcerative Colitis; Ileostomy Closure; Stoma Reversal Procedure

Keywords

hospital at home for colorectal surgery; postoperative hospital at home

Outcome Measures

Primary Outcomes (1)

• Number of recruited participants

  Recruitment success is defined as 50% of eligible patients

  one year

Secondary Outcomes (2)

• Number of drop-out participants

  one year

• Number of protocol deviations

  one year

Other Outcomes (11)

• Patient related endpoints (surgical complications)

  Thirty days after surgery

• Patient related endpoints (readmittance rate)

  Thirty days after surgery

• Patient related endpoints (Mortality)

  Thirty days after surgery

Study Arms (1)

virtual Hospital at Home

EXPERIMENTAL

participants admittet to virtual Hospital at Home

Other: virtual Hospital at Home

Interventions

virtual Hospital at Home OTHER

telemedicine set-up, virtual Hospital at Home

virtual Hospital at Home

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Nordsjaellands Hospital: lead

Study Sites (1)

Department of Surgery

Hillerød, 3400, Denmark

Location

Related Publications (3)

• 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.

  PMID: 36697356 BACKGROUND

• 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.

  PMID: 39587580 BACKGROUND

• 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.

  PMID: 23099039 BACKGROUND

MeSH Terms

Conditions

Colonic Neoplasms; Diverticulosis, Colonic; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Gastroenteritis; Colitis

Study Officials

• Kristin J Steinthorsdottir, MD, Ph.d.

  Nordsjaellands Hospital, Surgical Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristin J Steinthorsdottir, MD, Ph.d.

CONTACT

004531666112; kjs@dadlnet.dk

Claus A Bertelsen, MD, Ph.d.

CONTACT

004551906303; cabertelsen@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgeon, ph.d.

Model Details: Feasibility study

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: August 11, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)