No registrations found.
ID
Source
Brief title
Health condition
CECS
treatment
surgery
comparison
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
Efficacy (3 months after surgery) and the occurrence of complications. Efficacy will be determined by assessing complaint reduction using questionaires ( pre-operative and 3 months post operative). Patients will denote their complaints (pain, cramps, muscle weakness, tight feeling, sensibility disorders) using a 5-point Verbal Rating Scale Complications will be assessed by the responsible physician 2 weeks after surgery.
Background summary
N/A
Study objective
N/A
Study design
primary outcome. operation --> 2 weeks
Secondary outcome:
complications: 2 weeks post-operative
Efficacy: 3 months post-operative
Intervention
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.
Postbus 7777
Johan Bruijn, de
Veldhoven 5500 MB
The Netherlands
040-8886621
j.debruijn@mmc.nl
Postbus 7777
Johan Bruijn, de
Veldhoven 5500 MB
The Netherlands
040-8886621
j.debruijn@mmc.nl
Inclusion criteria
- 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.
Exclusion criteria
- Previous lower leg surgery
- Previous traumatic lower leg bone fracture
- Patients do not speak/underrstand Dutch
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4072 |
| NTR-old | NTR4274 |
| CCMO | NL44917.015.13 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON44856 |