Trial document





This trial has been registered retrospectively.
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  DRKS00004308

Trial Description

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Title

Is the transnasal access for upper gastrointestinal endoscopy in routine use equal to the transoral route? A prospective, randomized trial.

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Main intention:
Gastroscopies my be performed without sedation. This can be done traditionally through the mouth or, a rather new method, through the nose with a thinner gastroscope. The intention of our study is to find out, whether or not the new method is rated as equal to the older method by patients and examining physicians.

Background:
Gastroscopy through the nose finds increasing distribution. A natural option is to perform it without sedation. However, there are no investigations that prove, that access through the nose and through the mouth are equivalent.

What will be done:
Patients who take part in the study, are in medical need for a gastroscopy, but never had one before. They will be randomly assigned to a procedure either through the nose or through the mouth. After the procedure, they will fill out a questionnaire concerning how well the procedure was tolerated. In another group, patients who have previously had a gastroscopy through the mouth without sedation, and who are in medical need for another gastroscopy, will now recieve the procedure through the nose, again without sedation. These patients shall then rate how well they tolerated the new procedure compared to the procedure through the mouth.

Who can take part in the study:
Patients 18 yrs. or older, who are in need for a gastroscopy, with normal blood coagulation- values, who are not under legal custodianship and who never had a gastroscopy or who have had a previous gastroscopy through the mouth without sedation.

Aims of the study/we are trying to find out: how strong are the urge to gag, nausea and vomiting during the procedure; would the patient choose the same technique again in the future and would he prefer sedation or not and how acceptable does he find the overall- procedure.

Which assumptions are tested:
Do patients rate the different procedure types as equal? Is the new procedure through the nose not inferior to the standard procedure through the mouth?

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Brief Summary in Scientific Language

With the aim of comparing transnasal to transoral gastroscopies- both without sedation- in a routine setting, we conducted a multicenter, controlled, randomized, clinical trial.
The trial took place in two clinics (Klinikum Köln-Merheim and Klinikum Köln-Weyertal) and includes 304 patients. Three groups were formed. In group 1 (TNG), 93 patients underwent transnasal gastroscopy using a ultra- thin endoscope (5.9-6.0mm), in group 2 (TOG) 90 patients underwent transoral gastroscopy using standard endoscopes (9.4-9.8mm).These two techniques were evaluated and compared for the end- points feasibility, handling and patients' acceptance. Definied criteria, like procedural time, urge to gag, nausea, vomiting and nose bleeds were registred according to a self- designed questionnaire both by patients and the examining physician. These patients had their first gastroscopy ever and it was performed without sedation.
Furthermore, a third group (TNT) was fomred as a control group. This group consists of non- randomized patients, that have had a previous transoral gastroscopy without sedation and now get a transnasal gastroscopy without sedation. Thus, they can compare between transoral and transnasal access. These patients also rate their acceptance of the new procedure as compared to the earlier, transoral procedure.

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Organizational Data

  •   DRKS00004308
  •   2012/08/17
  •   [---]*
  •   yes
  •   Approved
  •   03-036, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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

  •   Diseases and conditions or disease- diagnostics, that necessitate upper GI- endoscopy:
    Unclear stomach- or upper abdominal pain
    Reflux- symptoms
    anemia- diagnostic
    Tumor- and varices- diagnostic
    Pre- und postoperative diagnostic
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Interventions/Observational Groups

  •   transnasal gastroscopy without sedation
  •   transoral gastroscopy without sedation
  •   transnasal gastroscopy without sedation after a previous transoral gastroscopy without sedation
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Characteristics

  •   Non-interventional
  •   Other
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control
  •   Diagnostic
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Evaluation of procedure- tolerance according to a self- designed questionnaire which was filled out by the patient and a physician who was not involved in the procedure. Questions included: urge to gag, nausea, vomiting, acceptance of procedural technique, preference of access route (transoral/ transnasal) and sedation in a possible endoscopic procedure in the future.
One- time evaluation directly after the procedure.

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Secondary Outcome

Patients' vote for transnasal or transoral access in case of an upper GI endoscopy in the future

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2004/04/06
  •   320
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

group 1 and 2: Indication for upper GI Endoscopy; first examination ever
group 3: Indication for upper GI Endoscopy; previous transoral upper GI- endoscopy without sedation

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Exclusion Criteria

Clotting disorder; Patients with psychiatric diseases; patients under custodianship

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Addresses

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Sources of Monetary or Material Support

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    • Medizinische Klinik I Krankenhaus Köln Merheim
    • Ostmerheimer Str. 200
    • 51109  Köln
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2006/11/21
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Trial Publications, Results and other Documents

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