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Main
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Note: This record shows only the 20 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. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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27 May 2013 |
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Main ID: |
NTR871 |
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Date of registration:
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15/01/2007 |
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Primary sponsor: |
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Public title:
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Timing of PEG tube placement in patients with amyotrophic lateral sclerosis: soon or later?
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Scientific title:
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Earlier PEG placement in ALS patients with dysphagia: effects on survival, nutritional and functional status, and quality of life -
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Date of first enrolment:
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4/8/2004 |
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Target sample size:
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20 |
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Recruitment status: |
recruiting |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=871 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: None; Control: Active; Group: Parallel; Type: -
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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M.
Visser, de |
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Address:
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Academic Medical Center, department of Neurology, PO box 22660
1100 DD
Amsterdam
The Netherlands |
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Telephone:
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Email:
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m.devisser@amc.uva.nl |
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Affiliation:
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Name:
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M.M.
Graaff, van der |
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Address:
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Academic Medical Centred, department of Neurology
PO box 22660
1100 DD
Amsterdam
The Netherlands |
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Telephone:
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+31205663647 |
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Email:
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m.m.vandergraaff@amc.uva.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Patients with possible, probable, probable lab supported, or definite ALS;
2. Dysphagia Hillel score 7 or 8 (ALSSS dyspagia subscale);
3. Vital capacity >65%;
4. Age > 18 yr and < 85 yr;
5. Informed consent.
Exclusion criteria: 1. Contra-indication for PEG
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Dysphagia, Amyotrophic Lateral Sclerosis (ALS)
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Intervention(s)
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Early PEG (PEG placement within 4 weeks after inclusion) versus a "wait and see approach", with probably a PEG placement at a later stage
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Primary Outcome(s)
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Survival
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Secondary Outcome(s)
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1. Vital capacity;
2. BMI;
3. Triceps skinfold;
4. ALSFRS;
5. VAS Q0L;
6. SF 36;
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Secondary ID(s)
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ISRCTN63827964
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N/A
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Source(s) of Monetary Support
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Prinses Beatrix Fonds
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