Trial document





This trial has been registered retrospectively.
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  DRKS00004495

Trial Description

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Title

Laparoscopic mesh-augmented hiatoplasty versus fundoplication as a treatment for gastroesophageal reflux disease

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Trial Acronym

M*A*S*H - Studie

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URL of the Trial

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Brief Summary in Lay Language

The aim of this study ist to compare LMAH (laparoscopic mesh-augmented hiatoplasty) with the standard operation, the LF (laparoscopic fundoplication) concerning controll of reflux, side-effects like gasbloat, dysphagia and qualitiy of life.

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Brief Summary in Scientific Language

The aim of this study ist to compare LMAH (laparoscopic mesh-augmented hiatoplasty) with LF (laparoscopic fundoplication) concerning controll of reflux, side-effects like gasbloat, dysphagia and qualitiy of life.

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Organizational Data

  •   DRKS00004495
  •   2012/11/09
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  •   yes
  •   Approved
  •   211/2006, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  •   U1111-1136-0288 
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Health Condition or Problem studied

  •   K21.9 -  Gastro-oesophageal reflux disease without oesophagitis
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Interventions/Observational Groups

  •   LMAH (laparoscopic mesh-augmented hiatoplasty), it is the interventional technique, in which the controll of reflux symptoms only is treated by a lengthening of the esophagus, mesh-augmented rebuilding of the anatomy at the hiatus and an anterior gastropexy in the area of cardia.
  •   LF (laparoscopic fundoplication), it is the standard technique, in this way there is no mesh used to reconstruct the hiatus esophagei. Only a fundoplication is build.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

In first line (main objecitve) we tried to say, if there are less surgical side-effects after laparoscopic mesh-augmented hiatoplasty in comparison with laparoscopic fundoplication. For this wie used 2 questionnaires to find out about disorders and quality of life. We used for disorders the "Gastrointestinal Symptom Rating Scale" (GSRS) and for quality of life the "Gastrointestinal Quality of Life Index" (GIQLI). These two questionnaires were answered before surgery and 3, 12 and 36 month after surgery.

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Secondary Outcome

Secondary objective is to say, if the lapaorscopic mesh-augmented hiatoplasty has an equal effect like laparoscopic fundoplication on recurrence rate of reflux: gastroscopy before and 12 month after surgery and 24-hours-acidimetry before and 3month after surgery. PPI (proton-pump-inhibitor)-Need was asked in GSRS-questionnaire before operation, 3, 12 and 36 month after operation.
Process while surgery and after surgery. Re-hospitalisation, pain, pressur of esophagus, complications while surgery, morbidity, Reintervention.
The patients said in the questionnaire how strong they see their pain before operation, 3, 12 and 36 month after operation.
The pressure of esophagus was measured by manometry before and 3 months after surgery.

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Countries of Recruitment

  •   Germany
  •   Switzerland
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2006/10/04
  •   90
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

age over 18 years, endoscopical or acidimetrial proof of gastroesophageal reflux disease, consequent proton-pump-inhibitor therapie for at least 3 months, patient agreement

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Exclusion Criteria

hiatal hernia type II-IV; surgery in case of recurrence, secundary gastroesophageale reflux disease, achalasia, Zollinger-Ellison-Syndrome, malignant tumour, ASA IV-V(American Society of Anesthesiologists), incompetence linguistical or mental to answer the questionaire

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Chirurgische Universitätsklinik
    • Mr.  Prof. Dr. med.  Markus W.  Büchler 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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    • Chirurgische Universitätsklinik
    • Mr.  PD Dr. med.  Beat  Müller 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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    • Chirurgische Universitätsklinik
    • Mr.  PD Dr. med.  Beat  Müller 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Chirurgische Universitätsklinik Heidelberg
    • Mr.  Prof. Dr. med.  Markus  Büchler 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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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.