Trial document




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  DRKS00009809

Trial Description

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Title

The value of turbinoplasty as part of septo-/septorhinoplasty - a prospective controlled randomised trial

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

Background:
The septoplasty is a surgical intervention to correct a septumdeviation. This means that the nasal septum tends to the left or the right side of the nose. Such a malposition can lead to the obstruction of the nasal breathing, which may affect the patient’s quality of life. This state also often affects the nasal turbinates, three mucous folds, which build the lateral walls of the nose. Their function is to moisten and heat up the breathing air. On the obstructed side of the nose the turbinates are reduced in size whereas the ones on the wider side are usually enlarged.
During a septoplasty the position of the nasal septum is repositioned. The functional septorhinoplasty additionally corrects the shape of the outer nose. In both cases the enlarged turbinates narrow the nasal passage immediately after the surgical intervention.
One possibility is to also reduce the size of the turbinates (turbinoplasty). However this can result in a limitation of their function.
The other possibility is not to manipulate the turbinates and to wait until they adapt to their new conditions. This means a less traumatic operation and a preservation of the functional mucosa.
Both procedures are established interventions, as there is no consistent opinion among ENT specialists about which one shows better results.

Aim:
The planned trial deals with the clinical value of turbinoplasty as part of septo-/ septorhinoplasty and scrutinizes, whether it is generally advantageous or may be avoided more frequently. There are two treatment groups. One receives an additional turbinoplasty, whereas the turbinates of the other group are not manipulated.The study evaluates the patient’s personal satisfaction as well as the measurable effects of the operation. The participants are recruited out of the patients, that undergo a septoplasty or functional septorhinoplasty in the ENT department of the university hospital of Ulm.

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Organizational Data

  •   DRKS00009809
  •   2016/01/12
  •   [---]*
  •   yes
  •   Approved
  •   326/15, Ethik-Kommission der Universität Ulm
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Secondary IDs

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Health Condition or Problem studied

  •   J34.2 -  Deviated nasal septum
  •   J34.3 -  Hypertrophy of nasal turbinates
  •   Q30.8 -  Other congenital malformations of nose
  •   M95.0 -  Acquired deformity of nose
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Interventions/Observational Groups

  •   Additionally to septo-/septorhinoplasty, turbinoplasty is performed as submucosally resection
  •   No additional turbinoplasty is performed after septo-/septorhinoplasty
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Characteristics

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

Patient's personal satisfaction:
The patient's symptoms are preoperatively evaluated by validated questionnaires (NOSE, SNOT20)
The second examination takes place immediately before discharge (modified NOSE).
Six months after the operation the patient is asked to complete the preoperatively used questionnaires again (NOSE, SNOT20) as well as an additional feedback questionnaire.

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Secondary Outcome

Width and patency of the nose:
Preoperatively the patients are examinated by rhinomanometry and acoustic rhinometry.
Six months after the operation, within the last consultation, these examinations are repeated.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/03/09
  •   80
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   60   Years
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Additional Inclusion Criteria

All patients that undergo a septoplasty or functional septorhinoplasty in the ENT department of the university hospital of Ulm, complain about a chronic obstruction of the nasal breathing and whose clinical evidence indicates a surgical intervention.

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Exclusion Criteria

1. Strong allergic symptoms
2. Nicotin consumption >1 package/d
3. Patients with obstructive sleep apnea syndrome
4. Previous operation on the nasal septum or the turbinates

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Addresses

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    • Universitätsklinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- und Halschirurgie Ulm
    • Frauensteige 12
    • 89075  Ulm
    • Germany
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    • Universitätsklinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- und Halschirurgie Ulm
    • Mr.  Prof. Dr. med.  Jörg  Lindemann 
    • Frauensteige 12
    • 89075  Ulm
    • Germany
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    • Universitätsklinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- und Halschirurgie Ulm
    • Mr.  Dr. med.  Fabian  Sommer 
    • Frauensteige 12
    • 89075  Ulm
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- und Halschirurgie Ulm
    • Frauensteige 12
    • 89075  Ulm
    • 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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