Transition to Ambulatory Bariatric Surgery (TABS) Trial
TABS
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2025
CompletedFirst Posted
Study publicly available on registry
June 9, 2025
CompletedStudy Start
First participant enrolled
March 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2028
June 13, 2025
June 1, 2025
1.8 years
June 5, 2025
June 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Emergency Department Visits
Number of emergency room visits after surgery
baseline to seven days
Secondary Outcomes (2)
Readmissions to the hospital
baseline to 30 days
The number of operations or procedures
baseline to 30 days
Study Arms (2)
Same Day Discharge
ACTIVE COMPARATORPatients 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 INTERVENTIONPatients in the standard of care arm will be admitted to the hospital for at least one overnight stay in the hospital.
Interventions
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.
Eligibility Criteria
You may qualify if:
- BMI ≤ 60 kg/m2
- Primary Sleeve gastrectomy or Gastric Bypass,
- Undergoing bariatric surgery at sponsor site
You may not qualify if:
- 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,
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vanderbilt University Medical Center
Nashville, Tennessee, 37209, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 5, 2025
First Posted
June 9, 2025
Study Start
March 1, 2026
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
May 1, 2028
Last Updated
June 13, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- 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.
- Access Criteria
- Data will be made available upon request after completion of appropriate institutional review board approval and data use agreement obtainment.
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.