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Comparison two surgical methods in the treatment of anterior CECS


- candidate number15742
- NTR NumberNTR4274
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-nov-2013
- Secondary IDsNL44917.015.13 toetsingonline CCMO
- Public TitleComparison two surgical methods in the treatment of anterior CECS
- Scientific TitleComparison between two surgical methods in the treatment of anterior chronic compartment syndrome: a patient blinded, randomized study.
- ACRONYMComparison two surgical methods in the treatment of anterior CECS
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedTreatment, Surgery
- 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
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 5-sep-2013
- planned closingdate1-aug-2015
- Target number of participants50
- Interventions 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.
- Primary outcomePrimary 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.
- Timepointsprimary outcome. operation --> 2 weeks Secondary outcome: complications: 2 weeks post-operative Efficacy: 3 months post-operative
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESMSc Johan Bruijn, de
- CONTACT for SCIENTIFIC QUERIESMSc Johan Bruijn, de
- Sponsor/Initiator Máxima Medical Center
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD22-nov-2013 - 18-dec-2013


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