Transition to Ambulatory Bariatric Surgery (TABS) Trial (TABS)

May 17, 2026 updated by: Jason Samuels, Vanderbilt University Medical Center
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37209
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Same Day Discharge
Patients in the same day discharge will be discharged from the hospital following surgery without an overnight stay in the hospital.
Other: Same Day Discharge
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.
No Intervention: Standard of care - Hospital Admission
Patients in the standard of care arm will be admitted to the hospital for at least one overnight stay in the hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emergency Department Visits
Time Frame: baseline to seven days
Number of emergency room visits after surgery
baseline to seven days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

June 5, 2025

First Submitted That Met QC Criteria

June 5, 2025

First Posted (Actual)

June 9, 2025

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 17, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 250548

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All participant-level data will be preserved and shared. Shared data will be deidentified prior to sharing. Clinicaltrials.gov will document recruitment progress and final results. Study protocols will be shared with publications as supplementary data and made available upon request. All participant consent document will be collected and stored electronically utilizing the REDCap study data repository. The REDCap data warehouse will also contain the study data dictionary. Study protocols have also been published on the ClinicalTrials.gov and any protocol amendments will be reflected on the ClinicalTrials.gov study page. The investigators will utilize the Research Electronic Data Capture (REDCap) data warehouse maintained locally at Vanderbilt for all data collection. Upon study completion and prior to closing the REDCap data warehouse for this study, the investigators will archive all data after removing patient identifiers in the Open Science Framework data repository.

IPD Sharing Time Frame

Per institutional policy, data will be maintained in the local REDCap data repository for 6 years after closure of the study. Following this period, data will be deidentified and uploaded to the OSF repository, which has funding for at least 50 years of data storage.

IPD Sharing Access Criteria

Data will be made available upon request after completion of appropriate institutional review board approval and data use agreement obtainment.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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