Trial document




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  DRKS00015488

Trial Description

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Title

Influence of body composition on perioperative outcome and effects of regular visualization of medical body composition after Mini Gastric Bypass/One Anastomosis Gastric Bypass (MGB/OAGB)

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Trial Acronym

none

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URL of the Trial

http://none

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Brief Summary in Lay Language

The purpose of this study is to examine whether the additional periodic body composition measurement (before and after surgery) has an effect on the postoperative development of weight and concomitant disease, as well as laboratory values ​​of patients after mini-bypass / one-anastomotic gastric bypass has. All patients who fulfill the inclusion criteria can take part.

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Brief Summary in Scientific Language

Bariatric surgery is currently the most effective treatment for obesity grade II or higher. In addition to permanent weight loss, patients benefit above all from a sustained improvement in numerous complications of obesity. The two most commonly performed procedures today (sleeve gastrectomy, gastric bypass) have in common that weight loss is rapid in the first few postoperative months and lowers in most patients after about one year. Over time, there is almost always a 10-20% increase in weight, but sometimes more. The average excess weight loss (excess weight loss) is about 60-70% (Sjöström L, Kushner RF).
Previous studies on the measurement of body composition have shown that in addition to the significant decrease in fat mass also a significant amount of muscle is lost (Otto M, Azevedo de Aquino L). Especially in the time of rapid weight loss, it is crucial to counteract a reduction of muscle mass through an optimized protein intake and increased physical activity (Mechanick JI, Coen PM).
Bariatric surgery has a significant positive impact on patients' quality of life (Lindekilde, 2015). The impact of a medical body composition analysis on quality of life and treatment adherence has not been studied.
Whether the manifestation of postoperative muscle mass loss or an already preexisting sarcopenia is a reliable predictor of the long-term weight development (Vassilev G, Mastino D), has an influence on the improvement of comorbidities and influences the quality of life of the affected patients or other parameters, has not been thoroughly investigated has been and is a goal of this study.
Similarly, the association between reduced muscle mass (sarcopenia) and increased risk of operative complications from other areas of abdominal surgery is known (Friedman J, Nishigori T). Another focus of this study is the observation of perioperative complications depending on the preoperative body composition.

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Organizational Data

  •   DRKS00015488
  •   2019/06/24
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  •   yes
  •   Approved
  •   PV5918, Ethik-Kommission der Ärztekammer Hamburg
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Secondary IDs

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Health Condition or Problem studied

  •   E66.82 -  [generalization E66.8: Other obesity]
  •   M62.59 -  [generalization M62.5: Muscle wasting and atrophy, not elsewhere classified]
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Interventions/Observational Groups

  •   Interventional arm:
    Health questionnaires and mBCA (medical Body Composition Analyzer) measurements preoperatively, as well as 6 weeks, 3 months and 6 months after operation with explanation of the measured values
  •   Control arm A:
    Health questionnaires and mBCA measurements preoperatively, as well as 6 weeks, 3 months and 6 months postoperatively without explanation of the measured values
  •   Control arm B:
    Questionnaires on health status and mBCA measurements preoperatively without explanation of the measurements, questionnaires 6 weeks, 3 months and 6 months postoperatively. mBCA measurement 6 months postoperatively
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Prevention
  •   Parallel
  •   IV
  •   N/A
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Primary Outcome

Preoperative primary endpoint:
Does the preoperative body composition influence the postoperative change in body composition?

Postoperative primary endpoint:
Does the regular measurement of the body composition pre- and postoperatively with visualization and quantification of the changes have influence the change of the body?

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Secondary Outcome

Preoperative secondary endpoints:
Does the preoperative body composition have influence on intra- and postoperative complications as well as the duration of the hospital stay?

Postoperative secondary endpoints:
The regular measurement of body composition pre- and postoperatively with visualization and quantification of the changes influences other parameters such as the initial extent of weight reduction, quality of life, psychological well-being, comorbidities, laboratory values, etc. (see secondary endpoints).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2019/06/26
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Existence of a cost assumption statement of the responsible payers for the planned intervention or fulfillment of the criteria of the S3 Guideline "Surgery of Obesity and metabolic disorders"
- Body mass index (BMI) preoperatively 40 to 60 kg / m²
- Mini Gastric Bypass / One-Anastomosis Gastric Bypass (MGB / OAGB) as a scheduled Operation
- Presence of signed patient information and consent

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Exclusion Criteria

- Prior Bariatric surgery
- Weight loss> 10% in the previous 3 months
- no present consent
- pregnancy
- known heart failure NYHA II or higher
- GFR <60 ml / min or known renal insufficiency KDIGO G3 or major change in diuretic therapy in the past 6 months
- Paralyzes, e.g. as a result of a stroke
- Amputations
- electric implants e.g. Pacemaker or ICD (implanted cardio defibrillator)
- insulin pumps
- persons dependent on the sponsor or the study Center
- alcohol addiction
- active prostheses
- electronic life support systems, e.g. Artificial heart, artificial lung
- mobile, electrical, medical devices, e.g. ECG, infusion pumps

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Addresses

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    • Adipositas Klinik Schön Klinik Hamburg Eilbek
    • Dehnhaide 120
    • 22081  Hamburg
    • Germany
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    • Adipositas Klinik, Schön Klinik Hamburg Eilbek
    • Mr.  Dr. med.  Torsten  Schorp 
    • Dehnhaide 120
    • 22081  Hamburg
    • Germany
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    • Adipositas Klinik, Schön Klinik Hamburg Eilbek
    • Mr.  Dr. med.  Torsten  Schorp 
    • Dehnhaide 120
    • 22081  Hamburg
    • Germany
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Sources of Monetary or Material Support

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    • Firma seca Gmbh & co.
    • Hammer Steindamm 3-25
    • 22089  Hamburg
    • 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.