Trial document




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  DRKS00005130

Trial Description

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Title

Eating behavior, nutrition, somatic and mental health 5 years after laporoscopic sleeve gastrectomy

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

In recent decades, obesity has dramatically increased worldwide. In particular, severe
obesity is related to various health-related disorders. They often have psychological problems and suffer from stigmatization. In this high-risk group, conservative weight reduction
programs often fail. Additionally, after conservative treatment, most patients regain weight.

Bariatric surgery is a proven treatment of morbid obesity, with excellent results in weight reduction. As a restrictive and single-stage procedure, laparoscopic sleeve gastrectomy (LSG) has demonstrated its efficacy in weight reduction and seems to incur low surgical and
nutritional risks. The number of LSG has dramatically increased within the last years. Nevertheless, there are only few if any studies which have evaluated eating and nutrition behaviour, physical and psychological health in the long-term (5 and more years after surgery).

In this study a follow-up examination of 276 patients who underwent 5 years ago LSG at the university hospital Tübingen, Germany, is planned. Preoperative and 5-year follow-up data will be compared in order to get insights into the changes of weight, eating behaviour and physical and psychological health. Additionally, examinations will be performed in order to assess nutrition intake, body composition and problems with the gastrointestinal tract.

The aim of the study is to better understand the impact of LSG on long-term eating behaviour, physical and psychological health and to identify predictors which give information on long-term weight loss/maintenance success and failure. This knowledge could then be used to improve future treatments in order to support the outcome of the LSG.

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Brief Summary in Scientific Language

In recent decades, obesity has dramatically increased worldwide. In particular, severe
obesity is related to various health-related disorders. They often have psychological problems and suffer from stigmatization. In this high-risk group, conservative weight reduction
programs often fail. Additionally, after conservative treatment, most patients regain weight.

Bariatric surgery is a proven treatment of morbid obesity, with excellent results in weight reduction. As a restrictive and single-stage procedure, laparoscopic sleeve gastrectomy (LSG) has demonstrated its efficacy in weight reduction and seems to incur low surgical and
nutritional risks. The number of LSG has dramatically increased within the last years. Nevertheless, there are only few if any studies which have evaluated eating and nutrition behaviour, physical and psychological health in the long-term (5 and more years after surgery).

In this study a follow-up examination of 276 patients who underwent 5 years ago LSG at the university hospital Tübingen, Germany, is planned. Preoperative and 5-year follow-up data will be compared in order to get insights into the changes of weight, eating behaviour and physical and psychological health. Additionally, examinations will be performed in order to assess nutrition intake, body composition and problems with the gastrointestinal tract.

The aim of the study is to better understand the impact of LSG on long-term eating behaviour, physical and psychological health and to identify predictors which give information on long-term weight loss/maintenance success and failure. This knowledge could then be used to improve future treatments in order to support the outcome of the LSG.

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Organizational Data

  •   DRKS00005130
  •   2013/08/20
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  •   yes
  •   Approved
  •   727/2012BO2, Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
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Secondary IDs

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Health Condition or Problem studied

  •   E65-E68 -  Obesity and other hyperalimentation
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Interventions/Observational Groups

  •   In this study 276 patients who underwent between 2005 and 2009 laparoscopic sleeve gastrectomy at the university hospital Tübingen, Tübingen, Germany, are included.
    Preoperative and 5-year follow-up data will be compared in order to get insights into the changes of weight, eating behaviour and physical and psychological health. Additionally, examinations will be performed in order to assess nutrition intake, body composition and problems with the gastrointestinal tract.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Percent (%) Excess Weigth Loss
Body weight was measured preoperative and will be measured in the follow-up using a calibrated scale. The percent (%) excess weigth loss will be derived from the relation between actual body weight and preoperative body weight

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Secondary Outcome

Changes of eating disorder symptoms, body image, depression and anxiety, perceived strains and somatic comorbidity.
The measurements were performed preoperative and will be performed in the follow up using the following instruments: EDE (eating disorder examination)-Interview, FEV (eating behaviour questionnaire), EDI-2 (Eating Disorder Inventory-2), SIAB (Structured questionnaire for anorexic and bulimic eating disorders), FKB-20 (Body Image Questionnaire), PHQ (Patient Health Questionnaire), PSQ (Perceived stress questionnaire).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2013/09/09
  •   276
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   90   Years
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Additional Inclusion Criteria

In this study 276 patients who underwent between 2005 and 2009 laparoscopic sleeve gastrectomy at the university hospital Tübingen, Tübingen, Germany, are included.

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Exclusion Criteria

Patients who did not underwent laparoscopic sleeve gastrectomy in the context of weight reduction or where the surgery did not take place at the university hospital Tübingen, Tübingen, Germany, are excluded from the study

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Addresses

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    • Medizinische Universitätsklinik TübingenAbteilung Innere Medizin VIPsychosomatische Medizin und Psychotherapie
    • Mr.  Dr. med.  Martin  Teufel 
    • Osianderstr. 5
    • 72076  Tübingen
    • Germany
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    • Universitätsklinikum Tübingen, Innere Medizin VI, Psychosomatische Medizin und Psychotherapie
    • Ms.  Dr.  Isabelle  Mack 
    • Frondsbergstr. 23
    • 72070  Tübingen
    • Germany
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    • Universtiätsklinikum TübingenChirurgische Klinik
    • Mr.  Prof. Dr.  A.  Königsrainer 
    • Hoppe Seyler Str. 3
    • 72076  Tübingen
    • Germany
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    • Universitätsklinikum TübingenChirurgische Klinik
    • Mr.  Dr.  T.  Meile 
    • Hoppe Seyler Str. 3
    • 72076  Tübingen
    • Germany
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    • Medizinische Universitätsklinik TübingenAbteilung Innere Medizin VIPsychosomatische Medizin und Psychotherapie
    • Mr.  Dr. med.  Martin  Teufel 
    • Osianderstr. 5
    • 72076  Tübingen
    • Germany
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    • Medizinische Universitätsklinik TübingenAbteilung Innere Medizin VIPsychosomatische Medizin und Psychotherapie
    • Mr.  Dr. med.  Martin  Teufel 
    • Osianderstr. 5
    • 72076  Tübingen
    • Germany
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Sources of Monetary or Material Support

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    • Kompetenznetz AdipositasKlinikum rechts der IsarTechnische Universität MünchenUptown München, Campus D
    • Georg-Brauchle-Ring 60/62
    • 80992  München
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2014/03/07
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Trial Publications, Results and other Documents

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