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Completed

NCT Number: NCT05259111

Home Hospital for Bariatric Sleeve Gastrectomy

Providing acute care at home for medicine patients is a well-studied care model. Providing acute care at home immediately following major surgery is less well understood. The investigators seek to demonstrate the noninferiority of care at home versus the hospital for patients undergoing bariatric sleeve gastrectomy.

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Key information

Conditions

Bariatric Surgery Candidate Bariatric Sleeve Gastrectomy Home Hospital

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Faulkner Hospital, Boston, Massachusetts, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All existing home hospital criteria apply, with the following taking precedent for this specific condition
  • 21-55 years old
  • Indication for bariatric laparoscopic sleeve gastrectomy per surgeon
  • Caregiver capable of communicating with the home hospital team and able to stay in the same home as the patient the first night the patient is home

Exclusion criteria

  • All existing home hospital criteria apply, with the following taking precedent for this specific condition
  • Comorbidities
  • Body mass index>55
  • Chronic kidney disease
  • Heart failure
  • History of
  • Chronic pain (with or without opioid use)
  • Substance use disorder
  • Venous thromboembolism
  • Stroke
  • Chronic headache
  • Medications
  • Anticoagulants and anti-platelets: aspirin, clopidogrel, warfarin, and direct oral anticoagulants
  • Beta blockade
  • Immunosuppressive
  • Supplemental oxygen
  • Allergy to ketorolac
  • Prolonged QTc

Treatment and study plan

Home hospital

Other

Acute care provided at home, including nurse/paramedic visits, physician visits, laboratory testing, imaging, continuous monitoring, 24/7 urgent visits, and specialty consultation.

Primary outcomes

  1. Length of Stay

    Time frame: From day of admission to day of discharge, assessed up to 10 months

    Days spent hospitalized

Secondary outcomes

  1. Motion

    Time frame: From day of admission to day of discharge, assessed up to 10 months

    Percent of the day lying down

  2. Cost, direct

    Time frame: From day of admission to day of discharge, assessed up to 10 months

    Presented as a percentage

  3. Opioid use

    Time frame: From day of admission to day of discharge, assessed up to 10 months

    Morphine milligram equivalents used

Other outcomes

  1. Rate of emergency department presentation

    Time frame: From day of discharge to 30 days later, assessed up to 10 months

    Emergency department presentation without admission

  2. Rate of readmission

    Time frame: From day of discharge to 30 days later, assessed up to 10 months

    Readmission to the hospital

  3. BodyQ Score

    Time frame: From day of admission to day of discharge, assessed up to 10 months

    Sum of the following three transformed scales (total of 300 points): Satisfaction with information (100 points) + Satisfaction with doctor/surgeon (100 points) + Satisfaction with medical team (100 points)

  4. Picker experience questionnaire - 15

    Time frame: From day of admission to day of discharge, assessed up to 10 months

    0-15 points, more points better

  5. Global experience score

    Time frame: From day of admission to day of discharge, assessed up to 10 months

    0-10 points, more points better

  6. Pain score

    Time frame: From day of admission to day of discharge, assessed up to 10 months

    Pain score on scale of 0-10, fewer points better

  7. Number of complications

    Time frame: From day of admission to day of discharge, assessed up to 10 months

    Sum of the complications included in the metabolic and bariatric surgery accreditation and quality improvement program

  8. Bed-days saved

    Time frame: From day of admission to day of discharge, assessed up to 10 months

    Acute care bed days not required due to the intervention

  9. Stage 2 diet

    Time frame: From day of admission to day of discharge, assessed up to 10 months

    Time to resumption of stage 2 diet, measured in hours

  10. 400mL intake

    Time frame: From day of admission to day of discharge, assessed up to 10 months

    Time to intake of 400mL, measured in hours

  11. 6 hours out of bed on post operative day 1

    Time frame: From day of admission to day of discharge, assessed up to 10 months

    Time to 6 hours out of bed on post operative day 1, measured in hours

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

Acute Care at Home for Adults Undergoing Bariatric Sleeve Gastrectomy: A Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 28, 2022
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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