EMG evaluation of the Pelvic Floor and Functional Outcomes in patients who underwent Rectal Cancer Treatment
- Conditions
- Pelvic floor functionrectal cancer10028302
- Registration Number
- NL-OMON55378
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 46
- Male and female patients who were treated for rectal cancer in the LUMC by
Low Anterior Resection (LAR), LAR preceded by Short Course RadioTherapy (SCRT <=
5x5 Gy), LAR preceded by ChemoRadioTherapy (CRT<= 25 fractions of 2 Gy with
concurrent capecitabine chemotherapy 825 mg/m2 bid), or CRT in a *wait-and-see*
trial.
- > 18 years of age.
- Proficiency of the Dutch language.
- Able and willing to fill in questionnaires alone or with help.
- Written informed consent.
- Patients who underwent abdominoperineal resection (APR) or Hartman resection.
- Patients with a diverting colostoma.
- Neurological comorbidity (spinal laesion or cerebrovascular accident (CVA))
or muscle disease (Multiple Sclerosis (MS)).
- Patients who deceased
- Patients with a local relapse
- Patients with metastasis in a distant organ
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is the EMG value of the pelvic floor measured in a patient<br /><br>who underwent rectal cancer treatment 1.5 * 4.5 years ago, measured as:<br /><br>- The mean of 10 x maximum voluntary contraction (MVC), where patients are<br /><br>instructed to perform 10 times a controlled contraction and relaxation of the<br /><br>pelvic floor muscles.<br /><br>The mean EMG value will be compared to the functional outcomes defined in the<br /><br>Low Anterior Resection Syndrome (LARS) score at 1.5 - 4.5 years after rectal<br /><br>cancer treatment, to study a correlation. </p><br>
- Secondary Outcome Measures
Name Time Method