Obesity, MorbidNCT04354532
Laparoscopic Banded Sleeve Gastrectomy
An observational study of Obesity, Morbid and Surgery, run by University of Rome Tor Vergata at 1 site in Italy.
Trial summary
Laparoscopic sleeve gastrectomy (LSG) is now the most common bariatric procedure to treat morbidly obese patients. The main concern of LSG lies in the long-term weight regain which is reported to happen in up to 75.6% of patients after 6 years. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Morbid, Surgery
- What is being tested?
- Laparoscopic Banded Sleeve Gastrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 209 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2014to 1 Feb 2020
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients submitted to primary LBSG were examined. Patients were submitted to LBSG between February 2014 and January 2020. Collected data included demographic factors, pre-operative weight, pre-operative BMI, operative time, surgical complications, and clinical outcomes in terms of short and mid-term weight loss.
Who may be able to join
- Severe Obesity with BMI > 35 kg/m2
Who cannot join
- Alcoholism
- Drug addiction
- Psychiatric Disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laparoscopic Banded Sleeve Gastrectomy: Single-Centre Experience With A 4-Year Follow-Up
Laparoscopic sleeve gastrectomy (LSG) is now the most common bariatric procedure to treat morbidly obese patients. The main concern of LSG lies in the long-term weight regain which is reported to happen in up to 75.6% of patients after 6 years. The Investigators report the overall experience with Laparoscopic Banded Sleeve Gastrectomy (LBSG) using the Minimizer over a six-year period.
Read the detailed description
Introduction. Laparoscopic sleeve gastrectomy (LSG) is now the most common bariatric procedure to treat morbidly obese patients. The main concern of LSG lies in the long-term weight regain which is reported to happen in up to 75.6% of patients after 6 years. The investigators report the overall experience with Laparoscopic Banded Sleeve Gastrectomy (LBSG) using the Minimizer over a six-year period.
Methods. The investigators performed a retrospective review of data from a prospectively collected database. All patients submitted to primary LBSG were examined. Patients were submitted to LBSG between February 2014 and January 2020. Collected data included demographic factors, pre-operative weight, pre-operative BMI, operative time, surgical complications, and clinical outcomes in terms of short and mid-term weight loss.
- Conditions
- Obesity, Morbid, Surgery
- Being tested
- Laparoscopic Banded Sleeve Gastrectomy
- Keywords
- Sleeve gastrectomy, Banded sleeve gastrectomy, Laparoscopy, Bariatric Surgery, Obesity
- Medical subject headings
- Obesity, Morbid, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Banded Sleeve GastrectomyProcedure or surgery
The investigators performed Laparoscopic Sleeve Gastrectomy adding a MiniMizer Ring (Bariatric Solutions), a radiopaque silicone ring with four closing positions. The ring has a blue colour and for this reason it can easily be found back in revision surgery. The pulling lid is left in place with all closing positions in order to be adjusted postoperatively without having to place a new ring. The ring is slightly elastic and the fixation loops provide an anchorpoint to fix the ring in place which prevents it from slipping
| Study group | Role | What they receive |
|---|---|---|
| 209 patients were submitted to primary LBSG | All patients submitted to primary Laparoscopic Banded Sleeve Gastrectomy were examined. Collected data included demographic factors, pre-operative weight, pre-operative BMI, operative time, surgical complications, and clinical outcomes in terms of short and mid-term weight loss. Receives: Procedure: Laparoscopic Banded Sleeve Gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
% Excess Weight Loss
Weight loss after laparoscopic banded sleeve gastrectomy during the follow-up
Measured: 4 years
Secondary outcomes (1)
Post-operative complications
Complications occurred after laparoscopic banded sleeve gastrectomy during the follow-up
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start1 Feb 2014
- Primary completion1 Jan 2020
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rome Tor Vergata
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Gentileschi, University of Rome Tor Vergata
- Investigators
- paolo gentileschi, MD, Principal investigator, University Hospital of Tor Vergata, Rome, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04354532
- Sponsor's protocol ID
- UNRome
- Status last verified
- Apr 2020
- First submitted
- 14 Apr 2020
- Last updated
- 21 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Welbourn R, Pournaras DJ, Dixon J, Higa K, Kinsman R, Ottosson J, Ramos A, van Wagensveld B, Walton P, Weiner R, Zundel N. Bariatric Surgery Worldwide: Baseline Demographic Description and One-Year Outcomes from the Second IFSO Global Registry Report 2013-2015. Obes Surg. 2018 Feb;28(2):313-322. doi: 10.1007/s11695-017-2845-9.
PubMed 28822052Lauti M, Kularatna M, Hill AG, MacCormick AD. Weight Regain Following Sleeve Gastrectomy-a Systematic Review. Obes Surg. 2016 Jun;26(6):1326-34. doi: 10.1007/s11695-016-2152-x.
PubMed 27048439Sarela AI, Dexter SP, O'Kane M, Menon A, McMahon MJ. Long-term follow-up after laparoscopic sleeve gastrectomy: 8-9-year results. Surg Obes Relat Dis. 2012 Nov-Dec;8(6):679-84. doi: 10.1016/j.soard.2011.06.020. Epub 2011 Jul 20.
PubMed 21890430Awad W, Garay A, Martinez C. Ten years experience of banded gastric bypass: does it make a difference? Obes Surg. 2012 Feb;22(2):271-8. doi: 10.1007/s11695-011-0555-2.
PubMed 22161231Lemmens L, Karcz WK, Bukhari W, Fink J, Kuesters S. Banded gastric bypass - four years follow up in a prospective multicenter analysis. BMC Surg. 2014 Nov 12;14:88. doi: 10.1186/1471-2482-14-88.
PubMed 25391401Fink JM, Hoffmann N, Kuesters S, Seifert G, Laessle C, Glatz T, Hopt UT, Konrad Karcz W, Marjanovic G. Banding the Sleeve Improves Weight Loss in Midterm Follow-up. Obes Surg. 2017 Apr;27(4):1098-1103. doi: 10.1007/s11695-017-2610-0.
PubMed 28214956Fink JM, von Pigenot A, Seifert G, Laessle C, Fichtner-Feigl S, Marjanovic G. Banded versus nonbanded sleeve gastrectomy: 5-year results of a matched-pair analysis. Surg Obes Relat Dis. 2019 Aug;15(8):1233-1238. doi: 10.1016/j.soard.2019.05.023. Epub 2019 May 24.
PubMed 31285129Parmar CD, Efeotor O, Ali A, Sufi P, Mahawar KK. Primary Banded Sleeve Gastrectomy: a Systematic Review. Obes Surg. 2019 Feb;29(2):698-704. doi: 10.1007/s11695-018-03626-1.
PubMed 30552547Tognoni V, Benavoli D, Bianciardi E, Perrone F, Ippoliti S, Gaspari A, Gentileschi P. Laparoscopic Sleeve Gastrectomy versus Laparoscopic Banded Sleeve Gastrectomy: First Prospective Pilot Randomized Study. Gastroenterol Res Pract. 2016;2016:6419603. doi: 10.1155/2016/6419603. Epub 2016 Apr 10.
PubMed 27143964Gentileschi P. Laparoscopic sleeve gastrectomy as a primary operation for morbid obesity: experience with 200 patients. Gastroenterol Res Pract. 2012;2012:801325. doi: 10.1155/2012/801325. Epub 2012 Jun 3.
PubMed 22701478Perrone F, Bianciardi E, Ippoliti S, Nardella J, Fabi F, Gentileschi P. Long-term effects of laparoscopic sleeve gastrectomy versus Roux-en-Y gastric bypass for the treatment of morbid obesity: a monocentric prospective study with minimum follow-up of 5 years. Updates Surg. 2017 Mar;69(1):101-107. doi: 10.1007/s13304-017-0426-z. Epub 2017 Mar 6.
PubMed 28266000Lemmens L, Van Den Bossche J, Zaveri H, Surve A. Banded Sleeve Gastrectomy: Better Long-Term Results? A Long-Term Cohort Study Until 5 Years Follow-Up in Obese and Superobese Patients. Obes Surg. 2018 Sep;28(9):2687-2695. doi: 10.1007/s11695-018-3248-2.
PubMed 29671124Filip S, Hutopila I, Copaescu C. Re-sleeve Gastrectomy - An Efficient Revisional Bariatric Procedure - 3 Years Results. Chirurgia (Bucur). 2019 Nov-Dec;114(6):809-823. doi: 10.21614/chirurgia.114.6.809.
PubMed 31928587Hanssen A, Plotnikov S, Acosta G, Nunez JT, Haddad J, Rodriguez C, Petrucci C, Hanssen D, Hanssen R. 3D Volumetry and its Correlation Between Postoperative Gastric Volume and Excess Weight Loss After Sleeve Gastrectomy. Obes Surg. 2018 Mar;28(3):775-780. doi: 10.1007/s11695-017-2927-8.
PubMed 28914408Cylke R, Skrzypek P, Ziemianski P, Domienik-Karlowicz J, Kosieradzki M, Lisik W. Single-anastomosis duodeno-ileal - new revision procedure in a patient with insufficient weight loss after sleeve gastrectomy. Wideochir Inne Tech Maloinwazyjne. 2018 Sep;13(3):407-411. doi: 10.5114/wiitm.2018.76686. Epub 2018 Jun 25.
PubMed 30302156
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Banded Sleeve Gastrectomy: Single-Centre Experience With A 4-Year Follow-Up
- ClinicalTrials.gov ID
- NCT04354532
- Acronym / sponsor ID
- UNRome
- Conditions
- Obesity, Morbid, Surgery
- Keywords
- Sleeve gastrectomy, Banded sleeve gastrectomy, Laparoscopy, Bariatric Surgery, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- University of Rome Tor VergataUniversity, hospital or other
- Study start
- 1 Feb 2014 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 21 Apr 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.
Laparoscopic sleeve gastrectomy (LSG) is now the most common bariatric procedure to treat morbidly obese patients. The main concern of LSG lies in the long-term weight regain which is reported to happen in up to 75.6% of patients after 6 years. The Investigators report the overall experience with Laparoscopic Banded Sleeve Gastrectomy (LBSG) using the Minimizer over a six-year period.
Detailed description
Introduction. Laparoscopic sleeve gastrectomy (LSG) is now the most common bariatric procedure to treat morbidly obese patients. The main concern of LSG lies in the long-term weight regain which is reported to happen in up to 75.6% of patients after 6 years. The investigators report the overall experience with Laparoscopic Banded Sleeve Gastrectomy (LBSG) using the Minimizer over a six-year period.
Methods. The investigators performed a retrospective review of data from a prospectively collected database. All patients submitted to primary LBSG were examined. Patients were submitted to LBSG between February 2014 and January 2020. Collected data included demographic factors, pre-operative weight, pre-operative BMI, operative time, surgical complications, and clinical outcomes in terms of short and mid-term weight loss.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 209 patients were submitted to primary LBSG | – | Procedure: Laparoscopic Banded Sleeve GastrectomyAll patients submitted to primary Laparoscopic Banded Sleeve Gastrectomy were examined. Collected data included demographic factors, pre-operative weight, pre-operative BMI, operative time, surgical complications, and clinical outcomes in terms of short and mid-term weight loss. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients submitted to primary LBSG were examined. Patients were submitted to LBSG between February 2014 and January 2020. Collected data included demographic factors, pre-operative weight, pre-operative BMI, operative time, surgical complications, and clinical outcomes in terms of short and mid-term weight loss.
Key inclusion criteria (1 listed)
- Severe Obesity with BMI > 35 kg/m2
Key exclusion criteria (3 listed)
- Alcoholism
- Drug addiction
- Psychiatric Disease
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 |
|---|---|---|
| Laparoscopic Banded Sleeve GastrectomyThe investigators performed Laparoscopic Sleeve Gastrectomy adding a MiniMizer Ring (Bariatric Solutions), a radiopaque silicone ring with four closing positions. The ring has a blue colour and for this reason it can easily be found back in revision surgery. The pulling lid is left in place with all closing positions in order to be adjusted postoperatively without having to place a new ring. The ring is slightly elastic and the fixation loops provide an anchorpoint to fix the ring in place which prevents it from slipping | Procedure or surgery | 209 patients were submitted to primary LBSG |
Primary outcome
% Excess Weight Loss
Time frame: 4 years
Weight loss after laparoscopic banded sleeve gastrectomy during the follow-up
1 secondary outcome
Post-operative complications
Time frame: 4 years
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 21 Apr 2020.
- Results publication: PubMed 28822052Welbourn R, Pournaras DJ, Dixon J, Higa K, Kinsman R, Ottosson J, Ramos A, van Wagensveld B, Walton P, Weiner R, Zundel N. Bariatric Surgery Worldwide: Baseline Demographic Description and One-Year Outcomes from the Second IFSO Global Registry Report 2013-2015. Obes Surg. 2018 Feb;28(2):313-322. doi: 10.1007/s11695-017-2845-9.
- Results publication: PubMed 27048439Lauti M, Kularatna M, Hill AG, MacCormick AD. Weight Regain Following Sleeve Gastrectomy-a Systematic Review. Obes Surg. 2016 Jun;26(6):1326-34. doi: 10.1007/s11695-016-2152-x.
- Results publication: PubMed 21890430Sarela AI, Dexter SP, O'Kane M, Menon A, McMahon MJ. Long-term follow-up after laparoscopic sleeve gastrectomy: 8-9-year results. Surg Obes Relat Dis. 2012 Nov-Dec;8(6):679-84. doi: 10.1016/j.soard.2011.06.020. Epub 2011 Jul 20.
- Results publication: PubMed 22161231Awad W, Garay A, Martinez C. Ten years experience of banded gastric bypass: does it make a difference? Obes Surg. 2012 Feb;22(2):271-8. doi: 10.1007/s11695-011-0555-2.
- Results publication: PubMed 25391401Lemmens L, Karcz WK, Bukhari W, Fink J, Kuesters S. Banded gastric bypass - four years follow up in a prospective multicenter analysis. BMC Surg. 2014 Nov 12;14:88. doi: 10.1186/1471-2482-14-88.
- Results publication: PubMed 28214956Fink JM, Hoffmann N, Kuesters S, Seifert G, Laessle C, Glatz T, Hopt UT, Konrad Karcz W, Marjanovic G. Banding the Sleeve Improves Weight Loss in Midterm Follow-up. Obes Surg. 2017 Apr;27(4):1098-1103. doi: 10.1007/s11695-017-2610-0.
- Results publication: PubMed 31285129Fink JM, von Pigenot A, Seifert G, Laessle C, Fichtner-Feigl S, Marjanovic G. Banded versus nonbanded sleeve gastrectomy: 5-year results of a matched-pair analysis. Surg Obes Relat Dis. 2019 Aug;15(8):1233-1238. doi: 10.1016/j.soard.2019.05.023. Epub 2019 May 24.
- Results publication: PubMed 30552547Parmar CD, Efeotor O, Ali A, Sufi P, Mahawar KK. Primary Banded Sleeve Gastrectomy: a Systematic Review. Obes Surg. 2019 Feb;29(2):698-704. doi: 10.1007/s11695-018-03626-1.
- Results publication: PubMed 27143964Tognoni V, Benavoli D, Bianciardi E, Perrone F, Ippoliti S, Gaspari A, Gentileschi P. Laparoscopic Sleeve Gastrectomy versus Laparoscopic Banded Sleeve Gastrectomy: First Prospective Pilot Randomized Study. Gastroenterol Res Pract. 2016;2016:6419603. doi: 10.1155/2016/6419603. Epub 2016 Apr 10.
- Results publication: PubMed 22701478Gentileschi P. Laparoscopic sleeve gastrectomy as a primary operation for morbid obesity: experience with 200 patients. Gastroenterol Res Pract. 2012;2012:801325. doi: 10.1155/2012/801325. Epub 2012 Jun 3.
- Results publication: PubMed 28266000Perrone F, Bianciardi E, Ippoliti S, Nardella J, Fabi F, Gentileschi P. Long-term effects of laparoscopic sleeve gastrectomy versus Roux-en-Y gastric bypass for the treatment of morbid obesity: a monocentric prospective study with minimum follow-up of 5 years. Updates Surg. 2017 Mar;69(1):101-107. doi: 10.1007/s13304-017-0426-z. Epub 2017 Mar 6.
- Results publication: PubMed 29671124Lemmens L, Van Den Bossche J, Zaveri H, Surve A. Banded Sleeve Gastrectomy: Better Long-Term Results? A Long-Term Cohort Study Until 5 Years Follow-Up in Obese and Superobese Patients. Obes Surg. 2018 Sep;28(9):2687-2695. doi: 10.1007/s11695-018-3248-2.
- 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.
paolo gentileschi, MD principal investigator
University Hospital of Tor Vergata, Rome, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Morbid and Surgery, 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 1 inclusion and 3 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 21 Apr 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?
% Excess Weight Loss (time frame: 4 years). 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 NCT04354532, which also lists 19 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 21 Apr 2020.