Bariatric Surgery, Obesity and Obesity-related Medical Conditions
Conditions
Keywords
ambulatory surgery, same day discharge, gastric bypass, sleeve gastrectomy
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).
Interventions
OTHERSame 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.
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Emergency Department Visits | baseline to seven days | Number of emergency room visits after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
CONTACTJason Samuels
Outcome results
None listed