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Not yet recruiting NCT06980402

Post-discharge Monitoring Initiative on Outcomes of Post-surgical Patients

No phase Interventional Laparoscopy Discharge Planning

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Early post-surgical discharge with post-surgical home based monitoring, Standard inpatient care until deemed suitable for discharge.
Who it may be relevant to
Registry conditions: Laparoscopy, Discharge Planning. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Pragmatic Pilot Study of SKH@Home Post-discharge Monitoring Initiative on Outcomes of Surgical Patients

Overview

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.

Interventions

  • Procedure Early post-surgical discharge with post-surgical home based monitoring
    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.
  • Procedure Standard inpatient care until deemed suitable for discharge
    Patients will receive standard postoperative management in the acute hospital until they are deemed fit for discharge by their primary surgeon

Primary outcome measures

  • Bed days saved [Time frame: From enrollment to 30 days after patient is discharged from the hospital/ post-discharge monitoring programme]
  • Return to hospital [Time frame: From enrollment until 30-days after patient is discharged from the hospital/ from post-discharge monitoring care]
  • Length of stay [Time frame: From enrollment until patient is discharged from the hospital/ from post-discharge monitoring care (up to around 2 weeks), whichever is longer]
  • Hospitalisation bill [Time frame: From enrollment until 30-days after patient is discharged from the hospital/ from post-discharge monitoring care]
  • Postoperative complications [Time frame: From enrollment until 30-days after patient is discharged from the hospital/ from post-discharge monitoring care]

Eligibility criteria

Inclusion criteria

  • 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

OR

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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, S PMID 34593374
  • 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. PMID 27016900
  • 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. PMID 33641013
  • 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. PMID 36812167
  • 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. PMID 39028346

Identifiers

NCT: NCT06980402 · 2024-4580

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗