- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04354532
Laparoscopic Banded Sleeve Gastrectomy
Laparoscopic Banded Sleeve Gastrectomy: Single-Centre Experience With A 4-Year Follow-Up
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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RM
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Rome, RM, Italy, 00133
- Michela Campanelli
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Severe Obesity with BMI > 35 kg/m2
Exclusion Criteria:
- Alcoholism
- Drug addiction
- Psychiatric Disease
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
% Excess Weight Loss
Time Frame: 4 years
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Weight loss after laparoscopic banded sleeve gastrectomy during the follow-up
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4 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-operative complications
Time Frame: 4 years
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Complications occurred after laparoscopic banded sleeve gastrectomy during the follow-up
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4 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: paolo gentileschi, MD, University Hospital of Tor Vergata, Rome, Italy
Publications and helpful links
General Publications
- Sarela 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.
- 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.
- Lauti 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.
- Awad 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.
- Lemmens 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.
- Fink 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.
- Fink 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.
- Parmar 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.
- Tognoni 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.
- Gentileschi 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.
- Perrone 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.
- Lemmens 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.
- Filip 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.
- Hanssen 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.
- Cylke 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.
- Montuori M, Benavoli D, D'Ugo S, Di Benedetto L, Bianciardi E, Gaspari AL, Gentileschi P. Integrated Approaches for the Management of Staple Line Leaks following Sleeve Gastrectomy. J Obes. 2017;2017:4703236. doi: 10.1155/2017/4703236. Epub 2017 Feb 2.
- Lemaitre F, Leger P, Nedelcu M, Nocca D. Laparoscopic sleeve gastrectomy in the South Pacific. Retrospective evaluation of 510 patients in a single institution. Int J Surg. 2016 Jun;30:1-6. doi: 10.1016/j.ijsu.2016.04.002. Epub 2016 Apr 8.
- Gentileschi P, Kini S, Catarci M, Gagner M. Evidence-based medicine: open and laparoscopic bariatric surgery. Surg Endosc. 2002 May;16(5):736-44. doi: 10.1007/s00464-001-8239-y. Epub 2002 Jan 4.
- Gentileschi P, Benavoli D, Arcudi C, Campanelli M, Valente M, Petagna L, Bianciardi E. Laparoscopic Banded Sleeve Gastrectomy: Single-Center Experience with a Four-Year Follow-Up. J Laparoendosc Adv Surg Tech A. 2021 Nov;31(11):1269-1273. doi: 10.1089/lap.2020.0726. Epub 2021 Jan 15.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UNRome
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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