NCT06980402

Brief Summary

The investigators are conducting a prospective study to evaluate the SKH@Home programme, a post-discharge monitoring initiative for surgical patients. The aim of this study is to conduct a pragmatic, non-randomized pilot study to compare the SKH@Home programme with standard post-surgical care on patient outcomes.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
34mo left

Started Jun 2025

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Jun 2025Jan 2029

First Submitted

Initial submission to the registry

February 20, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 20, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2029

Last Updated

May 20, 2025

Status Verified

May 1, 2025

Enrollment Period

3.6 years

First QC Date

February 20, 2025

Last Update Submit

May 12, 2025

Conditions

Keywords

Bariatric surgeryLaparoscopic surgeryAbdominal abscessesLiver abscessesDischarge planning

Outcome Measures

Primary Outcomes (5)

  • Bed days saved

    Bed days saved in the acute hospital setting

    From enrollment to 30 days after patient is discharged from the hospital/ post-discharge monitoring programme

  • Return to hospital

    Unplanned readmission/ return to the hospital within 30-days

    From enrollment until 30-days after patient is discharged from the hospital/ from post-discharge monitoring care

  • Length of stay

    Combined length of stay. For inpatients, will be time of admission till time of discharge from acute hospital For patients enrolled into post-discharge monitoring programme, will be from time of admission till time of discharge from post-discharge monitoring programme

    From enrollment until patient is discharged from the hospital/ from post-discharge monitoring care (up to around 2 weeks), whichever is longer

  • Hospitalisation bill

    Total non-subsidised hospitalisation bill size

    From enrollment until 30-days after patient is discharged from the hospital/ from post-discharge monitoring care

  • Postoperative complications

    30-day postoperative complications, graded by the Clavien-Dindo classification

    From enrollment until 30-days after patient is discharged from the hospital/ from post-discharge monitoring care

Study Arms (2)

Standard inpatient care until deemed suitable for discharge

ACTIVE COMPARATOR

Post-surgical patients are routinely monitored in the acute hospital setting, until they are deemed suitable for discharge by their primary surgeon.

Procedure: Standard inpatient care until deemed suitable for discharge

Early post-surgical discharge with post-surgical home based monitoring

EXPERIMENTAL

The SKH@home program, is a post-discharge monitoring program, which allows stable post-surgical patients (after minimally invasive/ endoscopic/ bariatric surgery) or with stable surgical conditions after interventions (like abdominal or liver abscess management) to be discharged earlier from the acute hospital while providing regular post-discharge monitoring at the patient's own home, either through home visits or patient assessment via telemonitoring.

Procedure: Early post-surgical discharge with post-surgical home based monitoring

Interventions

The SKH@home program, is a post-discharge monitoring program, which allows stable post-surgical patients to be discharged earlier from hospital while providing regular post-discharge monitoring at the patient's own home, either through home visits and patient assessment, or telemonitoring of patients.

Early post-surgical discharge with post-surgical home based monitoring

Patients will receive standard postoperative management in the acute hospital until they are deemed fit for discharge by their primary surgeon

Standard inpatient care until deemed suitable for discharge

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient is keen for home management
  • Hemodynamically stable
  • Able and willing to self-care and monitor / Good social support
  • Lives in Singapore's Northeast region
  • EITHER
  • Diagnosed with intra-abdominal abscess requiring ongoing IV antibiotics as recommended by Infectious Diseases Specialist where necessary OR Diagnosed with liver abscess requiring ongoing IV antibiotics as recommended by Infectious Diseases Specialist where necessary AND Has undergone initial treatment (e.g., drainage if required) and is clinically improving
  • Underwent an uneventful straightforward bariatric surgical procedure, and has been monitored overnight without any immediate postoperative issues OR Underwent uneventful straightforward laparoscopic/ endoscopic/ minimally invasive surgery, and has been monitored for at least 6 hours without any immediate postoperative issues AND has no significant intraprocedural concerns by the operating surgeon

You may not qualify if:

  • Unable to self-care / no caregiver
  • Requires daily review by the surgical team
  • Suspicion of surgical complications requiring surgical intervention
  • Requires post-discharge monitoring care for \> 2 weeks
  • Unregulated psychiatric disorders
  • Daily flushing of drains required

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • McGillion MH, Parlow J, Borges FK, Marcucci M, Jacka M, Adili A, Lalu MM, Ouellette C, Bird M, Ofori S, Roshanov PS, Patel A, Yang H, O'Leary S, Tandon V, Hamilton GM, Mrkobrada M, Conen D, Harvey V, Lounsbury J, Mian R, Bangdiwala SI, Arellano R, Scott T, Guyatt GH, Gao P, Graham M, Nenshi R, Forster AJ, Nagappa M, Levesque K, Marosi K, Chaudhry S, Haider S, Deuchar L, LeBlanc B, McCartney CJL, Schemitsch EH, Vincent J, Pettit SM, DuMerton D, Paulin AD, Simunovic M, Williams DC, Halman S, Harlock J, Meyer RM, Taylor DA, Shanthanna H, Schlachta CM, Parry N, Pichora DR, Yousuf H, Peter E, Lamy A, Petch J, Moloo H, Sehmbi H, Waggott M, Shelley J, Belley-Cote EP, Devereaux PJ; PVC-RAM-1 Investigators. Post-discharge after surgery Virtual Care with Remote Automated Monitoring-1 (PVC-RAM-1) technology versus standard care: randomised controlled trial. BMJ. 2021 Sep 30;374:n2209. doi: 10.1136/bmj.n2209.

  • Gunter RL, Chouinard S, Fernandes-Taylor S, Wiseman JT, Clarkson S, Bennett K, Greenberg CC, Kent KC. Current Use of Telemedicine for Post-Discharge Surgical Care: A Systematic Review. J Am Coll Surg. 2016 May;222(5):915-27. doi: 10.1016/j.jamcollsurg.2016.01.062. Epub 2016 Feb 13. No abstract available.

  • Jonker LT, Lahr MMH, Oonk MHM, de Bock GH, van Leeuwen BL. Post-discharge Telemonitoring of Physical Activity, Vital Signs, and Patient-Reported Symptoms in Older Patients Undergoing Cancer Surgery. Ann Surg Oncol. 2021 Oct;28(11):6512-6522. doi: 10.1245/s10434-021-09707-3. Epub 2021 Feb 27.

  • van Ede ES, Scheerhoorn J, Buise MP, Bouwman RA, Nienhuijs SW. Telemonitoring for perioperative care of outpatient bariatric surgery: Preference-based randomized clinical trial. PLoS One. 2023 Feb 22;18(2):e0281992. doi: 10.1371/journal.pone.0281992. eCollection 2023.

  • Cooper S, Patel S, Wynn M, Provost D, Hassan M. Outcomes of same-day discharge in bariatric surgery. Surg Endosc. 2024 Sep;38(9):5122-5129. doi: 10.1007/s00464-024-11053-w. Epub 2024 Jul 19.

MeSH Terms

Conditions

Abdominal AbscessLiver Abscess

Interventions

Drainage

Condition Hierarchy (Ancestors)

AbscessSuppurationInfectionsLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsSurgical Procedures, Operative

Study Officials

  • Koy Min Chue

    Sengkang General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant, Clinical Assistant Professor, Department of General Surgery

Study Record Dates

First Submitted

February 20, 2025

First Posted

May 20, 2025

Study Start

June 1, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

January 31, 2029

Last Updated

May 20, 2025

Record last verified: 2025-05