Morbid ObesityNCT03070457
Safety of an Early Discharge Protocol After Sleeve Gastrectomy
A study testing Early discharge and Conventional protocol in people with Morbid Obesity and Sleeve Gastrectomy, run by Hospital Universitari de Bellvitge at 1 site in Spain.
Trial summary
Evaluate the safety and efficacy of an early discharge protocol (23 hours, overnight stay) after scheduled sleeve gastrectomy. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Morbid Obesity, Sleeve Gastrectomy, Early Discharge
- What is being tested?
- Early discharge and Conventional protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2017to 31 Mar 2019
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients eligible for Sleeve gastrectomy
- BMI 35 to 50
- ASA I to III
- Conventional address close to our Hospital
- Laparoscopic surgery
- Accompanying person after discharge
- Availability for a smart phone
Who cannot join
- ASA IV
- Revisional Surgery
- Conversion to laparotomy
- ICU Admission after surgery
- Insulin dependent Diabetes Mellitus
- Surgery finishing after 3 pm
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
About this study
Official title: Safety of an Early Discharge Protocol After Sleeve Gastrectomy. Randomised Clinical Trial
Evaluate the safety and efficacy of an early discharge protocol (23 hours, overnight stay) after scheduled sleeve gastrectomy.
Read the detailed description
This study aims to demonstrate that a shorter hospital stay after sleeve gastrectomy is as safe and useful as conventional protocol with 48-36 hours of stay. We consider that an adequate patient information and support will facilitate this shorter stay
- Conditions
- Morbid Obesity, Sleeve Gastrectomy, Early Discharge, Safety Issues
- Being tested
- Early discharge, Conventional protocol
- Keywords
- bariatric surgery, sleeve gastrectomy, eras
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early dischargeOther
Patients randomised to early discharge or not
Conventional protocolOther
Discharge as usually done 48-72 hours after surgery
| Study group | Role | What they receive |
|---|---|---|
| Early discharge group | Experimental | Patients with a shorter hospital stay, 23 hours after surgery Receives: Other: Early discharge |
| Conventional discharge | Active comparator | Patients with conventional protocol and 48-72 hours of hospital stay Receives: Other: Conventional protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Readmissions rate
No hospital admissions after surgery
Measured: 1 month
Secondary outcomes (4)
Morbidity rate
Number of postoperative complications
Measured: 1 month
Chronogram for complications after surgery
Detailed timing of appearance
Measured: 1 month
Quality of life
BAROS questionnaire
Measured: 1 month
Patients agreement to the protocol
Specific survey created ad hoc
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start1 Mar 2017 (estimated)
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amador Garci-a Ruiz de Gordejuela, Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03070457
- Sponsor's protocol ID
- AC007/17
- Status last verified
- Feb 2017
- First submitted
- 24 Feb 2017
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of an Early Discharge Protocol After Sleeve Gastrectomy. Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT03070457
- Acronym / sponsor ID
- AC007/17
- Conditions
- Morbid Obesity, Sleeve Gastrectomy, Early Discharge, Safety Issues
- Keywords
- bariatric surgery, sleeve gastrectomy, eras
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Study start
- 1 Mar 2017 (estimated)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Mar 2019 (estimated)
- First posted
- 3 Mar 2017 (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.
Evaluate the safety and efficacy of an early discharge protocol (23 hours, overnight stay) after scheduled sleeve gastrectomy.
Detailed description
This study aims to demonstrate that a shorter hospital stay after sleeve gastrectomy is as safe and useful as conventional protocol with 48-36 hours of stay. We consider that an adequate patient information and support will facilitate this shorter stay
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early discharge group | Experimental | Other: Early dischargePatients with a shorter hospital stay, 23 hours after surgery |
| Conventional discharge | Active comparator | Other: Conventional protocolPatients with conventional protocol and 48-72 hours of hospital stay |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients eligible for Sleeve gastrectomy
- BMI 35 to 50
- ASA I to III
- Conventional address close to our Hospital
- Laparoscopic surgery
Key exclusion criteria (6 listed)
- ASA IV
- Revisional Surgery
- Conversion to laparotomy
- ICU Admission after surgery
- Insulin dependent Diabetes Mellitus
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 |
|---|---|---|
| Early dischargePatients randomised to early discharge or not | Other | Early discharge group |
| Conventional protocolDischarge as usually done 48-72 hours after surgery | Other | Conventional discharge |
Primary outcome
Readmissions rate
Time frame: 1 month
No hospital admissions after surgery
4 secondary outcomes
Morbidity rate
Time frame: 1 month
Chronogram for complications after surgery
Time frame: 1 month
Quality of life
Time frame: 1 month
Patients agreement to the protocol
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early discharge and Conventional protocol in people with Morbid Obesity and Sleeve Gastrectomy, run by Hospital Universitari de Bellvitge at 1 site in Spain.
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 7 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amador Garcia Ruiz de Gordejuela, MD, PhD (+35932607621, agrgordejuela@bellvitgehospital.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Readmissions rate (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Mar 2017.