Transition to Ambulatory Bariatric Surgery (TABS) Trial

Vanderbilt University Medical Center

Status: Begins enrollment this month

Conditions: Bariatric Surgery; Obesity and Obesity-related Medical Conditions

Treatments: Other: Same Day Discharge

Study type: Interventional

Funder types: Other

Identifiers

NCT07011628

250548

Details and patient eligibility

About

This study will compare same day discharge and at least one night stay in the hospital after bariatric surgery. Patients undergoing bariatric surgery will be randomized (i.e. have an equal chance of either plan) to either group. The study's primary outcome is the frequency patients in the study require a visit to the emergency room within 7 days of their surgery.

Full description

This pragmatic, parallel, randomized, open-label trial aims to determine the safety and feasibility of same day discharge (SDD) for bariatric surgery including sleeve gastrectomy and gastric bypass. Investigators will investigate the frequency of 7-day emergency department visits with SDD after bariatric surgery (Aim 1). In addition, the investigators will compare total 30-day charges between participants who undergo same day discharge versus those receive post-operative hospital admission (Aim 2).

Enrollment: 200 estimated patients

Sex: All

Ages: 25 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• BMI ≤ 60 kg/m2
• Primary Sleeve gastrectomy or Gastric Bypass,
• Undergoing bariatric surgery at sponsor site

Exclusion criteria

• Type 1 Diabetes
• Myocardial Infarction
• Unstable Angina or Heart Failure
• Prior Stroke
• Solid organ transplantation
• Systemic glucocorticoid prior 28 days
• Severe Obstructive Sleep Apnea
• Uncontrolled Hypertension (Systolic > 150, Diastolic > 90)
• Untreated Hyperthyroidism
• Chronic Kidney Disease (EGFR < 60)
• Current anticoagulant use,
• Poorly controlled Type 2 diabetes (Hemoglobin A1c in last 3 months > 8.5%)
• Chronic opioid use
• Insulin dependence.
• Need for extended venous thromboembolic event prophylaxis,
• > 1 lifetime bariatric surgery (revisional or conversion bariatric surgery)
• Patient lives > 130 miles from the hospital.
• Tobacco use in last 12 months
• Desire to become pregnant or active pregnancy
• Prisoners
• Unable or unwilling to follow-up
• Unable to understand or provide consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Same Day Discharge

Active Comparator group

Description:

Patients in the same day discharge will be discharged from the hospital following surgery without an overnight stay in the hospital.

Treatment:

Other: Same Day Discharge

Standard of care - Hospital Admission

No Intervention group

Description:

Patients in the standard of care arm will be admitted to the hospital for at least one overnight stay in the hospital.