To study the correlation between EMG values of the pelvic floor and functional outcomes of patients who has been treated for rectal cancer in the period January 2014 till December 2018.
ID
Source
Brief title
Condition
- Muscle disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the EMG value of the pelvic floor measured in a patient
who underwent rectal cancer treatment 1.5 * 4.5 years ago, measured as:
- The mean of 10 x maximum voluntary contraction (MVC), where patients are
instructed to perform 10 times a controlled contraction and relaxation of the
pelvic floor muscles.
The mean EMG value will be compared to the functional outcomes defined in the
Low Anterior Resection Syndrome (LARS) score at 1.5 - 4.5 years after rectal
cancer treatment, to study a correlation.
Secondary outcome
- The functional outcome at 1.5-4.5 years after rectal cancer treatment
expressed in Low Anterior Resections Syndrome (LARS) score.
- Faecal incontinence at 1.5 * 4.5 years after rectal cancer treatment defined
in the Vaizey score.
- Urinary incontinence at 1.5 -4.5 years after rectal cancer treatment
expressed in the International Consultation on Incontinence Questionnaire
Urinary Incontinence (ICIQ *UI) score.
- Urinary complaints at 1.5 * 4.5 years after rectal cancer treatment
expressed in the International Prostate Symptome Score (IPSS).
- Erectile dysfunction in men at 1.5 -4.5 years after rectal cancer treatment
defined in the International Index of Erectile Function (IIEF-5).
- Discomfort or pain during sexual intercourse in women at 1.5 -4.5 years after
rectal cancer treatment defined in the EORTC-IL 34 questionnaire
- Radiation dose to the different individual muscles of the pelvic floor.
Background summary
The prognosis of rectal cancer has improved in the last decade. As rectal
cancer patients often survive their disease, functional outcome after rectal
cancer treatment has become increasingly important. Patients without a
permanent colostomy can experience significant rates of faecal incontinence and
other anorectal complaints such as frequency, urgency and flatulence. Moreover,
after rectal cancer treatment urinary incontinence, difficulty in bladder
emptying and sexual dysfunction is seen. These functional outcomes have impact
on quality of life (QoL).
The rectum, anal sphincters, bladder, urethra and pelvic floor muscles are
essential in maintaining faecal and urinary continence. Surgery and
radiotherapy for rectal cancer treatment can cause damage to these components
which can lead to involuntary loss of faeces and urine. In patients with
already existing pelvic floor dysfunction, additional damage to pelvic floor
muscles and pelvic nerves is expected to further impair the continence
mechanism and is expected to result in worse functional outcomes. In short, we
expect pre-treatment function of the pelvic floor to influence post-treatment
functional outcomes.
However, no diagnostic tool is used to objectively measure the function of the
individual muscles of the pelvic floor in patients with rectal cancer. We
expect that measurement of the pelvic floor with electromyography (EMG) is
correlated to patients* postoperative functional outcomes. If so, measurement
of pre-treatment pelvic floor function with EMG may possibly predict the
functional outcomes after rectal cancer treatment, and therefore determine
treatment choices to a certain extent.
In this study the correlation between post-treatment EMG values of the pelvic
floor and post-treatment functional outcomes will be evaluated. When a positive
correlation is found, a successive study will be conducted to determine whether
pre-treatment EMG measurement of the pelvic floor is predictive for the
post-treatment functional outcomes. If so, patients and doctors can be informed
about the expected functional outcomes, which can contribute in decision making
for the surgeon to construct a permanent stoma instead of sphincter
preservation during Low Anterior Resection (LAR) and it can contribute to make
decisions about participating in the organ sparing *wait-and-see* treatment.
Study objective
To study the correlation between EMG values of the pelvic floor and functional
outcomes of patients who has been treated for rectal cancer in the period
January 2014 till December 2018.
Study design
Cross-sectional study.
Study burden and risks
Patients included in the study will have 1 additional hospital visit that will
last 1 hour. During this visit, an EMG measurement of the pelvic floor will be
performed. This will be done with an small anal probe, the Multiple Array Probe
Leiden (MAPLe).
No risks are associated with the use of the MAPLe.
After the measurement, patients will receive questionnaires about defecation,
micturition and sexual functioning. These questionnaires contain 25 questions
for women and 28 questions for men in total. Patients are able to complete the
questionnaires in a quiet room in the LUMC.
Patients will have no direct benefit from participation in this study.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
- 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.
Exclusion criteria
- 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
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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Other (possibly less up-to-date) registrations in this register
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In other registers
Register | ID |
---|---|
CCMO | NL66093.058.19 |