Trial document





This trial has been registered retrospectively.
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  DRKS00005264

Trial Description

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Title

Course of Qualitiy of life, psychological and clinical situation after obesity surgery

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Trial Acronym

QoL after obesity surgery

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Prospective, unicenter observer studie. All patients of a universitary obesity center will be analyzed to the course of quality of life and the psychological situation by an established standardised psychological questionare (EORTC QLQ C30). Defined dates are preoperative and 1, 3, 6, 12, 24, 36, 48, 60 months after operation. The data from this questionare analysis will be korellated on one site with the course of weight loss and comorbidities and on the other site with the data from the preopearative psychological interview.

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Brief Summary in Scientific Language

Unicenter, prospektive, non randomized, open, observity studie to the course of quality of life and psychological situation after obesity surgery.

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Organizational Data

  •   DRKS00005264
  •   2014/12/15
  •   [---]*
  •   yes
  •   Approved
  •   D 427/13, Ethikkommission der Christian-Albrechts-Universität zu Kiel
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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

  •   Course of quality of life and psychological and clinical situation after obesity surgery.
    Messurements: EORTC-Questionaires expanded with a specific obesity modul.
    Targets:
    1. Course of QoL of all patients after obesity surgery in the run of 5 years.
    2. Sub group analysis:Sleevegastrektomie vs. gastric bypass.
    Follow up: 1,3,6,12,24,26,48.60 months after Operation.


  •   Course of quality of life and psychological and clinical situation after obesity surgery of patients with abuse, violence experience or equal psychological trauma in their hystory
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

During the follow up the EORTC questionaires will be analysed 1,3.6.12,24,36,48,60 months after operation.
The end point are the EORTC questionaire results 5 years after Operation.
The follow up afer 5 years is also the end Point of the observation time.

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/02/26
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

BMI > 35 plus relevant comorbidities
BMI >/= 40
> 17 years old
obesity for more than 5 years
(According to the German S3 Guideline obesity surgery DGAV 2010)

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Exclusion Criteria

s. including criterias
Untreadet maligne desease
Maligne desease in the last 5 years
Untreadet or instabil psychiatric desease
Untreaded or instabil psychological disorder
Active drug abuse
Older than 75 years old
(According to the German S3 Guideline obesity surgery DGAV 2010)

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Allgemeine-, Visceral-, Thorax-, Transplantations- und Kinderchirurgie
    • Mr.  Dr. med.  Markus  Ahrens 
    • Arnold-Heller-Str. 3
    • 24105  Kiel
    • Germany
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  • start of 1:1-Block address scientific-contact
    • Klinik für Allgemeine-, Visceral-, Thorax-, Transplantations- und Kinderchirurgie
    • Mr.  Dr. med.  Markus  Ahrens 
    • Arnold-Heller-Str. 3
    • 24105  Kiel
    • Germany
    end of 1:1-Block address scientific-contact
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  • start of 1:1-Block address public-contact
    • Klinik für Allgemeine-, Visceral-, Thorax-, Transplantations- und Kinderchirurgie
    • Mr.  Dr. med.  Markus  Ahrens 
    • Arnold-Heller-Str. 3
    • 24105  Kiel
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Allgemeine-, Visceral-, Thorax-, Transplantations- und Kinderchirurgie
    • Mr.  Dr. med.  Markus  Ahrens 
    • Arnold-Heller-Str. 3
    • 24105  Kiel
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

  •   Küchler T, Ahrens M, et. al.:Lebensqualität nach bariatrischer Chirurgie. Chirurgische Allgemeine Zeitung, 11.+12.Heft, 13. Jahrgang, 2012
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* This entry means the parameter is not applicable or has not been set.