Transition to Ambulatory Bariatric Surgery (TABS) Trial

Not Applicable

Not yet recruiting

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

• Registration Number: NCT07011628
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

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.

Detailed 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).

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-05
• Study First Submitted QC: 2025-06-05
• Study First Posted: 2025-06-09
• Last Update Submitted: 2025-06-09
• Last Update Posted: 2025-06-13
• Study Start: 2026-03-01
• Primary Completion: 2027-12-01
• Study Completion: 2028-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Emergency Department Visits	baseline to seven days	Number of emergency room visits after surgery

Secondary Outcome Measures

Name	Time	Method
Readmissions to the hospital	baseline to 30 days	Study personnel will investigate the incidence of readmissions to the hospital in the post-surgical period.
The number of operations or procedures	baseline to 30 days	Study personnel will compare the frequency of reoperations and procedural interventions after surgery

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States