Home Hospital for Bariatric Sleeve Gastrectomy

Not Applicable

• Conditions: Bariatric Sleeve Gastrectomy; Home Hospital; Bariatric Surgery Candidate

• Registration Number: NCT05259111
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-02
• Study First Submitted: 2022-02-10
• Study First Submitted QC: 2022-02-18
• Study Start: 2022-02-23
• Study First Posted: 2022-02-28
• Last Update Submitted: 2022-02-28
• Last Update Posted: 2022-03-02
• Primary Completion: 2023-02-23
• Study Completion: 2023-03-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Length of Stay	From day of admission to day of discharge, assessed up to 10 months	Days spent hospitalized

Secondary Outcome Measures

Name	Time	Method
Cost, direct	From day of admission to day of discharge, assessed up to 10 months	Presented as a percentage
Opioid use	From day of admission to day of discharge, assessed up to 10 months	Morphine milligram equivalents used
Motion	From day of admission to day of discharge, assessed up to 10 months	Percent of the day lying down

Trial Locations

Locations (2)

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

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States