Obesity, MorbidNCT04228185
Banded Sleeve Gastrectomy Improves Weight Loss Compared to Non-banded Sleeve: Mid-term Results
A study testing sleeve gastrectomy in people with Obesity, Morbid, run by University of Rome Tor Vergata at 1 site in Italy.
Trial summary
Weight regain after Laparoscopic Sleeve Gastrectomy (LSG) is nowadays a growing concern. Sleeve dilatation and loss of food restriction is considered the main mechanism. The placement of a silicon ring around the gastric tube seems to give benefits in the short-term. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity, Morbid
- What is being tested?
- sleeve gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2014to Jan 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Morbid obesity
- Failure of medical treatment
- >18yrs; <60 yrs
Who cannot join
- Previous bariatric or GI surgery
- Psychiatric disease
- Pregnancy
- Contraindication to laparoscopy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Banded Sleeve Gastrectomy Improves Weight Loss Compared to Non-banded Sleeve: Mid-term Results From a Prospective Randomized Study
Weight regain after Laparoscopic Sleeve Gastrectomy (LSG) is nowadays a growing concern. Sleeve dilatation and loss of food restriction is considered the main mechanism. The placement of a silicon ring around the gastric tube seems to give benefits in the short-term.
The Investigators evaluate the efficacy of banded sleeve gastrectomy compared to standard sleeve in the mid-term.
Fifty patients were randomized between LSG and Laparoscopic Banded Sleeve Gastrectomy (LBSG), and they underwent a mean follow-up of 4 years.
Patients' management was exactly the same, apart from the band placement. After surgery differences in weight loss, operative time, complication rate and mortality were analyzed.
- Conditions
- Obesity, Morbid
- Being tested
- sleeve gastrectomy
- Keywords
- Sleeve gastrectomy, banded sleeve, obesity surgery
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sleeve gastrectomyProcedure or surgery
Comparison of banded and not-banded sleeve gastrectomy
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic banded sleeve gastrectomy | Experimental | Group undergoing banded sleeve Receives: Procedure: sleeve gastrectomy |
| Laparoscopic sleeve gastrectomy | Active comparator | Group undergoing standard sleeve Receives: Procedure: sleeve gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight loss
comparison of weight loss between the two procedures
Measured: from surgery to 4 years follow up
Secondary outcomes (1)
Complications
Short and mid-term complications
Measured: from surgery to 4 years follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study startJan 2014
- Primary completionJan 2015
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity, MorbidStudies 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
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rome Tor Vergata
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano D'Ugo, University of Rome Tor Vergata
- Investigators
- Stefano D'Ugo, MD PhD, Principal investigator, Tor Vergata University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04228185
- Sponsor's protocol ID
- Banded_Sleeve
- Status last verified
- Jan 2020
- First submitted
- 9 Jan 2020
- Last updated
- 14 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gentileschi P, Bianciardi E, Siragusa L, Tognoni V, Benavoli D, D'Ugo S. Banded Sleeve Gastrectomy Improves Weight Loss Compared to Nonbanded Sleeve: Midterm Results from a Prospective Randomized Study. J Obes. 2020 May 28;2020:9792518. doi: 10.1155/2020/9792518. eCollection 2020.
PubMed 32566276
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Banded Sleeve Gastrectomy Improves Weight Loss Compared to Non-banded Sleeve: Mid-term Results From a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT04228185
- Acronym / sponsor ID
- Banded_Sleeve
- Conditions
- Obesity, Morbid
- Keywords
- Sleeve gastrectomy, banded sleeve, obesity surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Rome Tor VergataUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 14 Jan 2020 (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.
Weight regain after Laparoscopic Sleeve Gastrectomy (LSG) is nowadays a growing concern. Sleeve dilatation and loss of food restriction is considered the main mechanism. The placement of a silicon ring around the gastric tube seems to give benefits in the short-term.
The Investigators evaluate the efficacy of banded sleeve gastrectomy compared to standard sleeve in the mid-term.
Fifty patients were randomized between LSG and Laparoscopic Banded Sleeve Gastrectomy (LBSG), and they underwent a mean follow-up of 4 years.
Patients' management was exactly the same, apart from the band placement. After surgery differences in weight loss, operative time, complication rate and mortality were analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic banded sleeve gastrectomy | Experimental | Procedure: sleeve gastrectomyGroup undergoing banded sleeve |
| Laparoscopic sleeve gastrectomy | Active comparator | Procedure: sleeve gastrectomyGroup undergoing standard sleeve |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Morbid obesity
- Failure of medical treatment
- >18yrs; <60 yrs
Key exclusion criteria (4 listed)
- Previous bariatric or GI surgery
- Psychiatric disease
- Pregnancy
- Contraindication to laparoscopy
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 |
|---|---|---|
| sleeve gastrectomyComparison of banded and not-banded sleeve gastrectomy | Procedure or surgery | Laparoscopic banded sleeve gastrectomy, Laparoscopic sleeve gastrectomy |
Primary outcome
weight loss
Time frame: from surgery to 4 years follow up
comparison of weight loss between the two procedures
1 secondary outcome
Complications
Time frame: from surgery to 4 years follow up
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 14 Jan 2020.
- Derived from this study: PubMed 32566276Gentileschi P, Bianciardi E, Siragusa L, Tognoni V, Benavoli D, D'Ugo S. Banded Sleeve Gastrectomy Improves Weight Loss Compared to Nonbanded Sleeve: Midterm Results from a Prospective Randomized Study. J Obes. 2020 May 28;2020:9792518. doi: 10.1155/2020/9792518. eCollection 2020.
- 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.
Stefano D'Ugo, MD PhD principal investigator
Tor Vergata University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sleeve gastrectomy in people with Obesity, Morbid, run by University of Rome Tor Vergata at 1 site in Italy.
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 3 inclusion and 4 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 14 Jan 2020. 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 Italy. 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?
weight loss (time frame: from surgery to 4 years follow up). 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 NCT04228185, which also lists 1 linked publication.
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 14 Jan 2020.