N/A
ID
Bron
Verkorte titel
Aandoening
CECS
treatment
surgery
comparison
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Primary outcome of the study is post-operative pain in the entry site and the leg in general, which patients will note on a daily basis for 2 weeks after surgery using a 11-point Numerical rating scale. This will be done for both separate legs. Furthermore, patients will note pain medication. Both will be collected in a questionnaire.
Achtergrond van het onderzoek
N/A
Doel van het onderzoek
N/A
Onderzoeksopzet
primary outcome. operation --> 2 weeks
Secondary outcome:
complications: 2 weeks post-operative
Efficacy: 3 months post-operative
Onderzoeksproduct en/of interventie
Included patients with double-sided CECS will undergo surgery with the Due fasciotome in one lower leg, while in the other lower leg the Fasciomax© will be used. The allocation of the intervention to either the right leg of left leg is randomized. Save the use of a different fasciotome the procedure and care for both legs is exactly equal.
Publiek
Postbus 7777
Johan Bruijn, de
Veldhoven 5500 MB
The Netherlands
040-8886621
j.debruijn@mmc.nl
Wetenschappelijk
Postbus 7777
Johan Bruijn, de
Veldhoven 5500 MB
The Netherlands
040-8886621
j.debruijn@mmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Male and female patients who are older than 18 years
- Chronic anterior compartment syndrome proven by clinical history, physical examination and pressure measurement
- Only the anterior lower leg compartment is affected, no combined compartment syndrome including lateral of posterior compartment involvement.
- Patients have comparable complaints in both lower legs
- Patients have given informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Previous lower leg surgery
- Previous traumatic lower leg bone fracture
- Patients do not speak/underrstand Dutch
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4072 |
| NTR-old | NTR4274 |
| CCMO | NL44917.015.13 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON44856 |