Bariatric Surgery CandidateNCT05259111
Home Hospital for Bariatric Sleeve Gastrectomy
A study testing Home hospital in people with Bariatric Surgery Candidate and Bariatric Sleeve Gastrectomy, run by Brigham and Women's Hospital at 2 sites in United States.
Trial summary
Providing acute care at home for medicine patients is a well-studied care model. Providing acute care at home immediately following major surgery is less well understood. The investigators seek to demonstrate the noninferiority of care at home versus the hospital for patients undergoing bariatric sleeve gastrectomy. Read more about this study
- Who is it for?
- Ages 21 to 55 years
- Conditions the study is for
- Bariatric Surgery Candidate, Bariatric Sleeve Gastrectomy, Home Hospital
- What is being tested?
- Home hospital
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Feb 2022to 24 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All existing home hospital criteria apply, with the following taking precedent for this specific condition
- 21-55 years old
- Indication for bariatric laparoscopic sleeve gastrectomy per surgeon
- Caregiver capable of communicating with the home hospital team and able to stay in the same home as the patient the first night the patient is home
Who cannot join
- All existing home hospital criteria apply, with the following taking precedent for this specific condition
- Comorbidities
- Body mass index>55
- Chronic kidney disease
- Heart failure
- History of
Show all 18Show fewer
- Chronic pain (with or without opioid use)
- Substance use disorder
- Venous thromboembolism
- Stroke
- Chronic headache
- Medications
- Anticoagulants and anti-platelets: aspirin, clopidogrel, warfarin, and direct oral anticoagulants
- Beta blockade
- Immunosuppressive
- Supplemental oxygen
- Allergy to ketorolac
- Prolonged QTc
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham and Women's Faulkner Hospital
Boston, Massachusetts, 02130
Brigham and Women's Hospital
Boston, Massachusetts, 02130
About this study
Official title: Acute Care at Home for Adults Undergoing Bariatric Sleeve Gastrectomy: A Randomized Controlled Trial
Providing acute care at home for medicine patients is a well-studied care model. Providing acute care at home immediately following major surgery is less well understood. The investigators seek to demonstrate the noninferiority of care at home versus the hospital for patients undergoing bariatric sleeve gastrectomy.
- Being tested
- Home hospital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home hospitalOther
Acute care provided at home, including nurse/paramedic visits, physician visits, laboratory testing, imaging, continuous monitoring, 24/7 urgent visits, and specialty consultation.
| Study group | Role | What they receive |
|---|---|---|
| Control, Care in the Hospital | No intervention | After bariatric sleeve gastrectomy, patients receive their care in the hospital, as usual. |
| Intervention, Care in the Home | Experimental | After bariatric sleeve gastrectomy, patients receive their care in the home. Receives: Other: Home hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Stay
Days spent hospitalized
Measured: From day of admission to day of discharge, assessed up to 10 months
Secondary outcomes (3)
Motion
Percent of the day lying down
Measured: From day of admission to day of discharge, assessed up to 10 months
Cost, direct
Presented as a percentage
Measured: From day of admission to day of discharge, assessed up to 10 months
Opioid use
Morphine milligram equivalents used
Measured: From day of admission to day of discharge, assessed up to 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start23 Feb 2022
- Primary completion24 Apr 2024
- Study completion24 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Levine, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05259111
- Sponsor's protocol ID
- 2017P002583e
- Status last verified
- Mar 2026
- First submitted
- 10 Feb 2022
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Leff B, Burton L, Mader SL, Naughton B, Burl J, Inouye SK, Greenough WB 3rd, Guido S, Langston C, Frick KD, Steinwachs D, Burton JR. Hospital at home: feasibility and outcomes of a program to provide hospital-level care at home for acutely ill older patients. Ann Intern Med. 2005 Dec 6;143(11):798-808. doi: 10.7326/0003-4819-143-11-200512060-00008.
PubMed 16330791Levine DM, Pian J, Mahendrakumar K, Patel A, Saenz A, Schnipper JL. Hospital-Level Care at Home for Acutely Ill Adults: a Qualitative Evaluation of a Randomized Controlled Trial. J Gen Intern Med. 2021 Jul;36(7):1965-1973. doi: 10.1007/s11606-020-06416-7. Epub 2021 Jan 21.
PubMed 33479931Bryan AF, Levine DM, Tsai TC. Home Hospital for Surgery. JAMA Surg. 2021 Jul 1;156(7):679-680. doi: 10.1001/jamasurg.2021.0597. No abstract available.
PubMed 33909002
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Care at Home for Adults Undergoing Bariatric Sleeve Gastrectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05259111
- Acronym / sponsor ID
- 2017P002583e
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 23 Feb 2022 (actual)
- Primary completion
- 24 Apr 2024 (actual)
- Study completion
- 24 May 2024 (actual)
- First posted
- 28 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Providing acute care at home for medicine patients is a well-studied care model. Providing acute care at home immediately following major surgery is less well understood. The investigators seek to demonstrate the noninferiority of care at home versus the hospital for patients undergoing bariatric sleeve gastrectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control, Care in the Hospital | No intervention | –After bariatric sleeve gastrectomy, patients receive their care in the hospital, as usual. |
| Intervention, Care in the Home | Experimental | Other: Home hospitalAfter bariatric sleeve gastrectomy, patients receive their care in the home. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- All existing home hospital criteria apply, with the following taking precedent for this specific condition
- 21-55 years old
- Indication for bariatric laparoscopic sleeve gastrectomy per surgeon
- Caregiver capable of communicating with the home hospital team and able to stay in the same home as the patient the first night the patient is home
Key exclusion criteria (18 listed)
- All existing home hospital criteria apply, with the following taking precedent for this specific condition
- Comorbidities
- History of
- Medications
- Allergy to ketorolac
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home hospitalAcute care provided at home, including nurse/paramedic visits, physician visits, laboratory testing, imaging, continuous monitoring, 24/7 urgent visits, and specialty consultation. | Other | Intervention, Care in the Home |
Primary outcome
Length of Stay
Time frame: From day of admission to day of discharge, assessed up to 10 months
Days spent hospitalized
3 secondary outcomes
Motion
Time frame: From day of admission to day of discharge, assessed up to 10 months
Cost, direct
Time frame: From day of admission to day of discharge, assessed up to 10 months
Opioid use
Time frame: From day of admission to day of discharge, assessed up to 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Background: PubMed 16330791Leff B, Burton L, Mader SL, Naughton B, Burl J, Inouye SK, Greenough WB 3rd, Guido S, Langston C, Frick KD, Steinwachs D, Burton JR. Hospital at home: feasibility and outcomes of a program to provide hospital-level care at home for acutely ill older patients. Ann Intern Med. 2005 Dec 6;143(11):798-808. doi: 10.7326/0003-4819-143-11-200512060-00008.
- Background: PubMed 33479931Levine DM, Pian J, Mahendrakumar K, Patel A, Saenz A, Schnipper JL. Hospital-Level Care at Home for Acutely Ill Adults: a Qualitative Evaluation of a Randomized Controlled Trial. J Gen Intern Med. 2021 Jul;36(7):1965-1973. doi: 10.1007/s11606-020-06416-7. Epub 2021 Jan 21.
- Background: PubMed 33909002Bryan AF, Levine DM, Tsai TC. Home Hospital for Surgery. JAMA Surg. 2021 Jul 1;156(7):679-680. doi: 10.1001/jamasurg.2021.0597. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home hospital in people with Bariatric Surgery Candidate and Bariatric Sleeve Gastrectomy, run by Brigham and Women's Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Stay (time frame: From day of admission to day of discharge, assessed up to 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05259111, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.