Transition to Ambulatory Bariatric Surgery (TABS) Trial

NCT ID: NCT07011628

Last Updated: 2025-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-01

Study Completion Date

2028-05-01

Brief Summary

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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

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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).

Conditions

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Obesity and Obesity-related Medical Conditions Bariatric Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Same Day Discharge

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

Group Type ACTIVE_COMPARATOR

Same Day Discharge

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanderbilt University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jason Samuels

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Central Contacts

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Jason Samuels

Role: CONTACT

(615) 322 - 4504 ext. 24504

Other Identifiers

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250548

Identifier Type: -

Identifier Source: org_study_id

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