Trial document




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  DRKS00017149

Trial Description

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Title

Gastroesophageal Rexlux Disease and Barretdysplasia after laparoscopic Sleeve Gastrectomy

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Trial Acronym

GERD/LSG

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The study investigate acid indigestion after a sleeve gastrectomy in its frequency and intensity. The symptoms are checked with a gastroscopy and questionnaries.

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Brief Summary in Scientific Language

Postoperative reflux after a laparoscopic sleevegastrectomy is a point of discussion in actual literature.
The aim of the study is to evaluate GERD-symptoms, hiatal hernation and quality of life after a laparoscopic sleeve gastrectomy.
it is a prospective study with 100 patients.
Preoperativie examination will be a gastroscopy and BQL and RSI quastionnaries.

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Organizational Data

  •   DRKS00017149
  •   2019/06/13
  •   [---]*
  •   yes
  •   Approved
  •   18-6527-BR, Ethik-Kommission der Medizinischen Fakultät der Ruhr-Universität Bochum
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Secondary IDs

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

  •   K21.0 -  Gastro-oesophageal reflux disease with oesophagitis
  •   R12 -  Heartburn
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Interventions/Observational Groups

  •   Patients undergoing a Sleeve Gastrectomy to treat morbid obesity will be examined regarding the development of GERD with a gastroscopy and questionnaires prior to the operation und 1 year afterwards.
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Characteristics

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

Proof of Reflux ( symptoms, endoscopical findings), 1 year after performing Sleeve Gastrectomy with the use of questionnaires and upper endoscopy.

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Secondary Outcome

Appearance of hiatal herniation, weight loss und assessment of the quality of life, 1 year after Sleeve Gastrectomy with the use of upper endoscopy, weight. measurement of weight and questionnaires.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2019/06/12
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

1. Obesity, Classification I-III (BMI>30kg/m²), preexisting for at least 5 years with severe comorbidities
2. Attempted weight loss through conservative methods for at least 6 months with unseccessful results
3. Performing a laparoscopic sleeve gastrectomy to treat morbid obesity
4. Patients' aggrement for follow up tests

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Exclusion Criteria

1. Patients younger as 18 years
2. Patients with a BMI <30kg/m²
3. Patients with psycological problems or alcohol/drug addiction

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Allgemein- und Viszeralchirurgie Klinikum Vest Knappschaftskrankenhaus Recklinghausen
    • Mr.  Professor  Martin  Buesing 
    • Dorstener Str. 151
    • 45647  Recklinghausen
    • Germany
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    • Allgemein- und Viszeralchirurgie Klinikum Vest Knappschaftskrankenhaus Recklinghausen
    • Mr.  Professor  Martin  Buesing 
    • Dorstener Str. 151
    • 45647  Recklinghausen
    • Germany
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    • Allgemein- und Viszeralchirurgie Klinikum Vest Knappschaftskrankenhaus Recklinghausen
    • Mr.  Professor  Martin  Buesing 
    • Dorstener Str. 151
    • 45647  Recklinghausen
    • Germany
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Sources of Monetary or Material Support

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    • Allgemein- und Viszeralchirurgie Klinikum Vest Knappschaftslrankenhaus Recklinghausen
    • Mr.  Prof.  Martin  Buesing 
    • Dorstener Str. 151
    • 45657  Recklinghausen
    • 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.