Home Hospital for Bariatric Sleeve Gastrectomy

Mass General Brigham

Status: Unknown

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

Treatments: Other: Home hospital

Study type: Interventional

Funder types: Other

Identifiers

NCT05259111

2017P002583e

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 21 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Control, Care in the Hospital

No Intervention group

Description:

After bariatric sleeve gastrectomy, patients receive their care in the hospital, as usual.

Intervention, Care in the Home

Experimental group

Description:

After bariatric sleeve gastrectomy, patients receive their care in the home.

Treatment:

Other: Home hospital