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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Same Day Discharge | Active Comparator | Patients in the same day discharge will be discharged from the hospital following surgery without an overnight stay in the hospital. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Emergency Department Visits | Number of emergency room visits after surgery | baseline to seven days |
| Measure | Description | Time Frame |
|---|---|---|
| Readmissions to the hospital | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jason Samuels | Contact | (615) 322 - 4504 | 24504 | jason.m.samuels@vumc.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37209 | United States |
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.
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.
Data will be made available upon request after completion of appropriate institutional review board approval and data use agreement obtainment.
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Study personnel will compare the frequency of reoperations and procedural interventions after surgery
| baseline to 30 days |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |