Transition to Ambulatory Bariatric Surgery (TABS) Trial

NCT07011628 — Not applicable, Recruiting, 200 participants, Vanderbilt University Medical Center

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Registry	NCT07011628, acronym TABS
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	200 (Estimated)
Sponsor	Vanderbilt University Medical Center (Other)
Conditions	Obesity and Obesity-related Medical Conditions, Bariatric Surgery
Interventions	Same Day Discharge (Other)
Dates	start 2026-10-01 (estimated), primary completion 2027-10-01 (estimated), completion 2028-05-01 (estimated), first posted 2025-06-09, last updated 2026-09-21
Locations	1 site in United States

-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.

Expand all sections · Collapse all

+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).

+Arms and interventions

Arm	Type	Interventions	Description
Same Day Discharge	Active comparator	Other: Same Day Discharge	Patients in the same day discharge will be discharged from the hospital following surgery without an overnight stay in the hospital.
Standard of care - Hospital Admission	No intervention		Patients in the standard of care arm will be admitted to the hospital for at least one overnight stay in the hospital.

Same Day Discharge (Other): Patients in the same day discharge arm will be discharged from the hospital within 6 hours of arriving to the recovery unit and without an overnight stay in the hospital.

+Outcome measures

Primary outcomes

Emergency Department Visits [baseline to seven days]: Number of emergency room visits after surgery

Secondary outcomes

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

+Eligibility

Sex: All, ages: 25 Years to 55 Years

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

+Locations (1)

Facility	City	Country	Status
Vanderbilt University Medical Center	Nashville, Tennessee	United States	Recruiting