Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
German Clinical Trials Register |
Last refreshed on:
|
8 April 2024 |
Main ID: |
DRKS00011012 |
Date of registration:
|
21/11/2016 |
Prospective Registration:
|
Yes |
Primary sponsor: |
|
Public title:
|
Questionnaire on the clinical praxis of percutaneous endoscopic gastrostomy insertion in patients with autosomal recessive polycystic kidney disease (ARPKD)
|
Scientific title:
|
Questionnaire on the clinical praxis of percutaneous endoscopic gastrostomy insertion in patients with autosomal recessive polycystic kidney disease (ARPKD) |
Date of first enrolment:
|
01/02/2017 |
Target sample size:
|
200 |
Recruitment status: |
Complete |
URL:
|
http://drks.de/search/en/trial/DRKS00011012 |
Study type:
|
observational |
Study design:
|
Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: other
|
Phase:
|
|
|
Countries of recruitment
|
Belgium
|
Czechia
|
France
|
Germany
|
Italy
|
Poland
|
Portugal
|
Spain
|
Turkey
|
United Kingdom
| | | | | | |
Contacts
|
Name:
|
Kathrin
Burgmaier |
Address:
|
Kerpener Str. 62
50937
Köln
Germany |
Telephone:
|
0221/478-4359 |
Email:
|
kathrin.burgmaier@uk-koeln.de |
Affiliation:
|
Klinik für Kinder- und JugendmedizinUniklinik Köln |
|
Name:
|
Kathrin
Burgmaier |
Address:
|
Kerpener Str. 62
50937
Köln
Germany |
Telephone:
|
0221/478-4359 |
Email:
|
kathrin.burgmaier@uk-koeln.de |
Affiliation:
|
Klinik für Kinder- und JugendmedizinUniklinik Köln |
| |
Key inclusion & exclusion criteria
|
Inclusion criteria: The interviewed colleagues work at centers for pediatric nephrolgy or pediatric hepatology in Europe and diagnosed ARPKD due to clinical criteria in the patients. The data of ARPKD patients are questioned in an anonymous and retrospective manner.
Exclusion criteria: not willing to participate
Age minimum:
None
Age maximum:
None
Gender:
All
|
Health Condition(s) or Problem(s) studied
|
Polycystic kidney, autosomal recessive
|
Q61.1
|
Q61.1
|
Intervention(s)
|
Group 1: Conduction of a webbased, anonymous questionnaire of attending physicians of European pediatric nephrology and gastroenterology centers questioning the common practice regarding PEG implantations in ARPKD patients. In case, there is expericence with PEG implantation in ARPKD patients, details will be collected, such as technique of insertion, age and hepatic manifestation of the patient at insertion, performance of dialysis at insertion, complication of PEG insertion (leckage, infection, varices, re-operation). Furthermore handling of PEG in case of transplantation will be queried. The questionnaire is concluded by assessment of general benefits and risks of PEG implantation in ARPKD patients (including weight developmet and growth).
|
Primary Outcome(s)
|
It is the aim of the questionnaire to collect data regarding the current practice of PEG (percutaneous endoscopic gastrostomy) implantations in ARPKD (autosomal recessive polycystic kidney disease) patients in European pediatric centers and the experiences obtained. Benefit and risks of the intervention are evaluated in a retrospective manner in order to create first evidence regarding this important therapy in patients suffering from this serious disease of early childhood.
|
Source(s) of Monetary Support
|
Universitätsklinikum Köln
|
Ethics review
|
Status: Approved
Approval date: 07/11/2016
Contact:
gs-ek@uni-koeln.de
Ethikkommission der Medizinischen Fakultät der Universität zu Köln
+49-221-478 82900
gs-ek@uni-koeln.de
|
|