Long-term results after surgical treatment of diffuse idiopathic skeletal hyperostosis (DISH) causing dysphagia
Organizational Data
- DRKS-ID:
- DRKS00013049
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2017-09-19
- Last update in DRKS:
- 2019-07-25
- Registration type:
- Prospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
Diffuse idiopathic skeletal thyroidosis (DISH), also known as the Morbus Forestier, is a non-inflammatory, systemic skeletal disease. This results in an ossification of tendon attachment sites. Above all, the spine is affected. There is a bony bridging of the intervertebral discs. As a result, pronounced bone pores (osteophytes) are formed, which can impair the swallowing action in the region of the cervical spine. The resulting swallowing disorder (dysphagia) can be so pronounced that the osteophytes must be removed surgically. Since the disease pattern is rare, there is very little literature and, in particular, little long-term results with regard to surgical therapy. The aim of this research project is the retrospective recording of the perioperative and postoperative course of treatment in surgical therapy of patients with dysphagia due to diffuse idiopathic skeletal hyperostosis as well as the collection of data on long - term prognoses by means of telephone interviews and questionnaires or in the case of current complaints with a clarification request from the patient in the Framework of an outpatient investigation.
Brief summary in scientific language
In the case of unsuccessful conservative therapy of swallowing disorder, the operative removal of the space-demanding osteophytes is recommended by several authors as effective treatment (1 - 3). However, these are studies which, on the one hand, involve very few patients and, on the other hand, often only refer to the short-term postoperative course. Only individual studies are concerned with the long-term trend (4). 1. Goel R, Sampath P, Mikaelian DO. Dysphagia caused by cervical osteophytes: three cases treated by surgery. Otolaryngol Head Neck Surg 1999, 120: 92-6. 2. Fuerderer S, Eysel-Gosepath K, Schroder U, et al. Retro-pharyngeal obstruction in association with osteophytes of the cervical spine. J Bone Joint Surg Br 2004, 86: 837-40. 3. Kritzer RO, Parker WD. DISH: a cause of anterior cervical osteophyte-induced dysphagia. Spine 1988, 13: 130-2. 4. Urrutia J, Bono CM. Long-term results of surgical treatment of dysphagia secondary to cervical diffuse idiopathic skeletal hyperostosis. Spine, J. 2009, (9): e13-7
Health condition or problem studied
- ICD10:
- M48.10
- ICD10:
- R13 - Dysphagia
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Patients ≥ 18 years with diffuse idiopathic skeletal hyperostosis who were treated surgically during the period from 2005 to 2015 due to dysphagia: Retrospective recording of the perioperative and postoperative course of treatment as well as the collection of data on long-term prognoses by means of telephone interviews and questionnaires or in the case of current complaints with a clarification request from the patient in the Framework of an outpatient investigation.
Endpoints
- Primary outcome:
- Retrospective survey of the short-term improvement of the dysphagia after surgery by medical records and survey of the long-term results via questionnaires / telephone interviews
- Secondary outcome:
- Retrospective survey of perioperative data (perioperative and postoperative complications, hoarseness, cervical discomfort, difficulty with breathing; etiology of diffuse idiopathic skeletal hyperostosis (diabetes, lipid disorder, exposure to fluorides, vitamins A, obesity, hypertension, hyperinsulina, hyperuricaemia) by medical records and survey of the long-term results (recurrence of hyperostoses in imaging, patient satisfaction, course of disease) by questionnaires / telephone interviews
Study Design
- Purpose:
- Treatment
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Klinik für Neurochirurgie Freiburg im Breisgau
Recruitment period and number of participants
- Planned study start date:
- 2017-10-02
- Actual study start date:
- 2017-10-02
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2018-01-01
- Target Sample Size:
- 5
- Final Sample Size:
- 5
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- Patients ≥ 18 years with diffuse idiopathic skeletal thyroidosis who were treated surgically during the period from 2005 to 2015 due to dysphagia.
Exclusion Criteria
Patients < 18 years
Addresses
Primary Sponsor
- Address:
- Universitätsklinikum FreiburgHugstetter Strasse 4979095 FreiburgGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinik-freiburg.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Klinik für Neurochirurgie Universitätsklinikum FreiburgDr. Christoph ScholzBreisacher Str. 6479106 FreiburgGermany
- Telephone:
- 076127050010
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinik-freiburg.de
Contact for Public Queries
- Address:
- Klinik für Neurochirurgie Universitätsklinikum FreiburgDr. Christoph ScholzBreisacher Str. 6479106 FreiburgGermany
- Telephone:
- 076127050010
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinik-freiburg.de
Principal Investigator
- Address:
- Klinik für Neurochirurgie Universitätsklinikum FreiburgDr. Christoph ScholzBreisacher Str. 6479106 FreiburgGermany
- Telephone:
- 076127050010
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinik-freiburg.de
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Klinik für Neurochirurgie Universitätsklinikum FreiburgBreisacher Str. 6479106 FreiburgGermany
- Telephone:
- 076127050010
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinik-freiburg.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Albert-Ludwigs-Universität FreiburgEngelberger Str. 2179106 FreiburgGermany
- Telephone:
- +49-761-27072600
- Fax:
- +49-761-27072630
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2017-06-05
- Ethics committee number:
- 318/17
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2017-07-18
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- Long-term results after surgical treatment of diffuse idiopathic skeletal hyperostosis (DISH) causing dysphagia.
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry