Trial document




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  DRKS00016143

Trial Description

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Title

Bariatric surgery: is a postoperative follow-up program using a mobile application safe and feasible?

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Trial Acronym

BELLA

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URL of the Trial

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Brief Summary in Lay Language

After bariatric surgery, patients should be followed up for the rest of their life. However, the long-term follow-up rate is low. Many factors play a role here. Important reasons are lack of time and long travel. One possible solution to this worldwide problem is follow-up using telemedicine. With the help of a smartphone application "BELLA" they can be followed up independent of daytime and location according to their care plan. On the day of the scheduled follow-up patients will get a questionaire through the application. Upon request, patients can contact us via BELLA, e-mail or the phone. In emergencies, patients are asked to go to the emergency room immediatelyto visit or to alert the rescue service.

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Brief Summary in Scientific Language

In recent years, telemedicine has found its application in surgery. Previous studies have demonstrated the initial success of telemedicine in general, thoracic, transplant and vascular surgery. Bariatric surgery is a highly standard surgical discipline in terms of surgical technique as well as postoperative follow up. The postoperative follow-up includes mainly history (food intake, substitution of vitamins, participation in exercise program, etc.) and physical examination (wound control, weight control). A well-known problem in bariatric surgery is the low long-term follow-up rate. It has been proven that adherence to a follow-up program is critical to improving and maintaining weight loss. One of the most common reasons for absence in the control appointments is the long journey.
Back pain is a known problem in obese patients, although the mechanism of the trigger is not fully understood. The assumption is a loss of height of the intervertebral disc L4-L5. The treatment of back pain unfortunately does not belong to the standard aftercare of bariatric surgery.
Our hypothesis is, a follow-up program with an innovative smartphone application in patients undergoing bariatric surgery is at least as safe and feasible as the traditional presentation in the consultation.

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Organizational Data

  •   DRKS00016143
  •   2019/01/11
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  •   yes
  •   Approved
  •   2018-643N-MA, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
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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

  •   follow up using a cell phone application for 12 months
  •   follow up in the outpatient clinic
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Supportive care
  •   Parallel
  •   I
  •   N/A
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Primary Outcome

- satisfaction of patients
- cost for patients and for the health system
- weight loss
- a questionnaire which we developed ourselves will be sent to the patients after 12 months

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Secondary Outcome

- scala of back pain
- mortality and morbidity
- a questionnaire which we developed ourselves will be sent to the patients after 12 months

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2019/02/01
  •   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

- patients undergoing bariatric surgeries
- patients with a smart phone with internet access
- patients who can give informed consent

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Exclusion Criteria

- patients with language barrier or with mental diseases
- patients with severe complications (grade II, III and IV according to Clavin-Dindo classification)
- insufficient compliance

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Addresses

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    • Chirurgische Klinik, Universitätsmedizin Mannheim
    • Mr.  PD.Dr.  Mirko  Otto 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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    • Chirurgische Klinik, Universitätsmedizin Mannheim
    • Mr.  PD. Dr.  Mirko  Otto 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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    • Chirurgische Klinik, Universitätsmedizin Mannheim
    • Ms.  Dr.  Cui  Yang 
    • Theodor-Kutzer-Ufe 1-3
    • 68167  Mannheim
    • Germany
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Sources of Monetary or Material Support

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    • Chirurgische Klinik, Universitätsmedizin Mannheim
    • Mr.  PD. Dr.  Mirko  Otto 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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