Laparoscopic Revision Gastric Bypass for Inadequate Initial Weight Loss (IIWL)
28 december 2009 bijgewerkt door: University of California, San Francisco
Laparoscopic Revision Gastric Bypass for Inadequate Initial Weight Loss After Gastric Bypass: Intermediate Results
The main aim of this study is to analyze and report traditional, patient-centered, and composite intermediate-term outcomes after laparoscopic revision Roux-en-Y gastric bypass surgery for inadequate initial weight loss.
Studie Overzicht
Toestand
Voltooid
Gedetailleerde beschrijving
There is lack of standardization of primary and revisional bariatric surgery compounded by a scant long-term outcome data.
The treatment of inadequate weight loss, weight recidivism, and most severe technical complications after primary bariatric surgery remains refractory to non-operative treatment.
Failure rates have been reported up to 20% and 35% for the morbidly obese (MO) and super obese (SO), respectively at 2 to 3 years after surgery.
The indication for further surgical intervention remains controversial, as does what type of revisional procedure, both operative and endoscopic, to recommend.
Furthermore, there is no standardization of the limb lengths, pouch size or the use of prosthetic reinforcement.
Therefore the approach to these patients must be as individualized as their original operations.
We formally analyze our experience with all laparoscopic revisional strategies for Inadequate Initial Weight Loss after failed Roux-en-Y gastric bypass(RYGB).
Studietype
Observationeel
Inschrijving (Werkelijk)
42
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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California
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Fresno, California, Verenigde Staten, 93701
- UCSF Fresno Center for Medical Education and Research
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 65 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
Patients that underwent laparoscopic revision gastric bypass after previously failed Roux-en-Y gastric bypass "RYGB" with an Inadequate initial weight loss "IIWL" pattern.
Beschrijving
Inclusion Criteria:
- laparoscopic revisional RYGB for failed RYGB with IIWL or non-responders pattern
Exclusion Criteria:
- failed RYGB with a WR pattern
- patients with prior major bariatric conversion or esophago-gastric surgeries
- RYGB patients revised by an open surgical approach
- RYGB patients who underwent laparoscopic revisional RYGB surgery somewhere else and continue their follow-up care with program
- missing records and/or unreachable patients with scan information for analysis
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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Inadequate initial weight loss after gastric bypass
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Morbiditeit en mortaliteit
Tijdsspanne: gedurende de hele follow-up
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gedurende de hele follow-up
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Gezondheidsgerelateerde kwaliteit van leven (HR-KvL)
Tijdsspanne: eindelijk vervolg
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eindelijk vervolg
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Comorbiditeitsstatus
Tijdsspanne: gedurende de hele follow-up
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gedurende de hele follow-up
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Subjective satisfaction
Tijdsspanne: at the last follow-up
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at the last follow-up
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Weight loss expressed as Body Mass Index and Percentage excess weight loss
Tijdsspanne: at the lowest weight loss point and at last follow-up
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at the lowest weight loss point and at last follow-up
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Failure/success rate
Tijdsspanne: at yearly intervals throughout follow-up
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at yearly intervals throughout follow-up
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Metabolic and nutritional variables
Tijdsspanne: throughout follow-up
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throughout follow-up
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Kelvin D Higa, MD, Professor of Surgery, University of California San Francisco
- Studie directeur: Francisco M Tercero, MD, Research Associate, University of California San Franisco
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
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Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 oktober 2009
Primaire voltooiing (Werkelijk)
1 december 2009
Studie voltooiing (Werkelijk)
1 december 2009
Studieregistratiedata
Eerst ingediend
23 december 2009
Eerst ingediend dat voldeed aan de QC-criteria
28 december 2009
Eerst geplaatst (Schatting)
29 december 2009
Updates van studierecords
Laatste update geplaatst (Schatting)
29 december 2009
Laatste update ingediend die voldeed aan QC-criteria
28 december 2009
Laatst geverifieerd
1 oktober 2009
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CMC IRB No. 2009077
- U1111-1113-0264 (Andere identificatie: World Health Organization, Universal Trial Number)
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