Trial document




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  DRKS00008969

Trial Description

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Title

Fundectomy in gastric Bypass

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Trial Acronym

FuGaBy

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The aim of the study is to evaluate the effect of the synchronous Resektion of the gastric Fundus during gastric bypass on postoperative levels of the "hunger Hormon" ghrelin and weight loss. A similar effect has been shown for the gastric sleeve operation.
Patients that receive gastric Bypass at one of the two participating centers are included. Follow up takes place during the regular postoperative controls.

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Brief Summary in Scientific Language

Effect of synchronous fundectomy on ghrelin levels and weight loss after Roux-Y-gastric bypass

Background: The gastric sleeve operation for morbid obesity is rising in number worldwide. Its effect on overweight and comorbidities is far above the pure restrictive effect. The main location for the synthesis of the appetite Mediation hormon ghrelin in the human organism is the gastric fundus. So it seems probable, that at least a partial Effekt of the gastric sleeve can be lead to the decreased ghrelin levels. Since the resektion of the gastric fundus during the gastric bypass operation leads to a technical simplifikation, it has become technical standard at the UAZM.
The FuGBY study ist to show, whether the synchrones fundectomie leads to a postive postoperative effect besides the technical simplifikation.

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Organizational Data

  •   DRKS00008969
  •   2015/08/11
  •   [---]*
  •   yes
  •   Approved
  •   10/12, Ethik-Kommission des Fachbereichs Medizin der Justus-Liebig-Universität Gießen
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   E66.02 -  [generalization E66.0: Obesity due to excess calories]
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Interventions/Observational Groups

  •   Proximal Roux-Y-gastric bypass including fundectomie in the UKGM Giessen
  •   Proximal Roux-Y-gastric bypass without fundectomie in the Hospital of Frisoyte
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Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   No
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Primary Outcome

Ghrelin-levels 12 months postoperatively

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Secondary Outcome

Exzess weight loss 12 months postoperative

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Planned
  •   2015/09/01
  •   100
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

BMI above 40, only primary interventions (no redo-surgery), Indikation following S3-guideline in Germany

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Exclusion Criteria

Previous bariatric or gastric surgery

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Addresses

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    • UKGM Standort Giessen
    • Rudolf-Buchheim-Sr. 7
    • 35392  Giessen
    • Germany
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    • St. Marien-Krankenhaus Frisoyte
    • Mr.  Dr. med.  Ralf  Weise 
    • St.-Marien-Straße 1
    • 26169  Friesoythe
    • Germany
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    • Universitäres Adipositaszentrum Mittelhessenam UKGM, Standort Giessen
    • Mr.  Dr. med.  Jens  Albrecht 
    • Rudolf-Buchheim-Sr. 7
    • 35392  Giessen
    • Germany
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    • UKGM Standort Giessen
    • Mr.  Dr. med.  Jens  Albrecht 
    • Rudolf-Buchheim-Str. 7
    • 35392  Giessen
    • Germany
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Sources of Monetary or Material Support

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    • UKGM, Standort Giessen
    • Rudolf-Buchheim-Sr. 7
    • 35392  Giessen
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.