Laparoscopic Revision Gastric Bypass for Inadequate Initial Weight Loss (IIWL)
28 décembre 2009 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Description détaillée
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).
Type d'étude
Observationnel
Inscription (Réel)
42
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
California
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Fresno, California, États-Unis, 93701
- UCSF Fresno Center for Medical Education and Research
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 65 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Patients that underwent laparoscopic revision gastric bypass after previously failed Roux-en-Y gastric bypass "RYGB" with an Inadequate initial weight loss "IIWL" pattern.
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
|---|
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Inadequate initial weight loss after gastric bypass
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
La morbidité et la mortalité
Délai: tout au long du suivi
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tout au long du suivi
|
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Qualité de vie liée à la santé (HR-QoL)
Délai: au dernier suivi
|
au dernier suivi
|
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Statut de comorbidité
Délai: tout au long du suivi
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tout au long du suivi
|
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Subjective satisfaction
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Failure/success rate
Délai: at yearly intervals throughout follow-up
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at yearly intervals throughout follow-up
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Metabolic and nutritional variables
Délai: throughout follow-up
|
throughout follow-up
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Kelvin D Higa, MD, Professor of Surgery, University of California San Francisco
- Directeur d'études: Francisco M Tercero, MD, Research Associate, University of California San Franisco
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
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Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 octobre 2009
Achèvement primaire (Réel)
1 décembre 2009
Achèvement de l'étude (Réel)
1 décembre 2009
Dates d'inscription aux études
Première soumission
23 décembre 2009
Première soumission répondant aux critères de contrôle qualité
28 décembre 2009
Première publication (Estimation)
29 décembre 2009
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
29 décembre 2009
Dernière mise à jour soumise répondant aux critères de contrôle qualité
28 décembre 2009
Dernière vérification
1 octobre 2009
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CMC IRB No. 2009077
- U1111-1113-0264 (Autre identifiant: World Health Organization, Universal Trial Number)
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