Laparoscopic Banded Sleeve Gastrectomy
18 april 2020 uppdaterad av: Paolo Gentileschi, University of Rome Tor Vergata
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Faktisk)
209
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
RM
-
Rome, RM, Italien, 00133
- Michela Campanelli
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 65 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
Inclusion Criteria:
- Severe Obesity with BMI > 35 kg/m2
Exclusion Criteria:
- Alcoholism
- Drug addiction
- Psychiatric Disease
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
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.
|
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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
% Excess Weight Loss
Tidsram: 4 years
|
Weight loss after laparoscopic banded sleeve gastrectomy during the follow-up
|
4 years
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Post-operative complications
Tidsram: 4 years
|
Complications occurred after laparoscopic banded sleeve gastrectomy during the follow-up
|
4 years
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: paolo gentileschi, MD, University Hospital of Tor Vergata, Rome, Italy
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 februari 2014
Primärt slutförande (Faktisk)
1 januari 2020
Avslutad studie (Faktisk)
1 februari 2020
Studieregistreringsdatum
Först inskickad
14 april 2020
Först inskickad som uppfyllde QC-kriterierna
18 april 2020
Första postat (Faktisk)
21 april 2020
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
21 april 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
18 april 2020
Senast verifierad
1 april 2020
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- UNRome
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
OBESLUTSAM
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Kirurgi
-
Assistance Publique Hopitaux De MarseilleOkänd
-
Medistim ASAHar inte rekryterat ännuCardiac Bypass Surgery (CABG)
-
AstraZenecaAvslutad
-
Hospices Civils de LyonAvslutadMatpreferenser Variationer beroende på Bariatric Surgery StatusFrankrike
-
Karolinska InstitutetErsta Hospital, SwedenAvslutadLoopileostomi | Fast Track-program, (Enhanced Recovery After Surgery (ERAS))Sverige
-
Universitaire Ziekenhuizen KU LeuvenUniversity Hospital, Ghent; University Hospital, Antwerp; Imelda Hospital... och andra samarbetspartnersRekryteringBariatric Surgery Status som komplicerar graviditetenBelgien
-
University College DublinAvslutad
-
University of PittsburghIndragenPostoperativ smärta | Abdominal Body Contouring SurgeryFörenta staterna
-
Dong YangOkändLaparoskopi-assisterad kirurgi | Total laparoskopisk kirurgi utan snitt (Natural Orifice Transluminal Endoscopic Surgery, NOES)Kina
-
Kahramanmaras Sutcu Imam UniversityHar inte rekryterat ännuPostoperativ smärta | Erector Spinae Plane Block i Spinal Surgery
Kliniska prövningar på Laparoscopic Banded Sleeve Gastrectomy
-
Tel-Aviv Sourasky Medical CenterAvslutadViktminskning | Lever Steatos | LeverfibrosIsrael
-
North Shore Hospital, New ZealandAvslutadFetma | Typ 2-diabetes mellitusNya Zeeland