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EMG evaluation of the Pelvic Floor and Functional Outcomes in patients who underwent Rectal Cancer Treatment

EMG evaluation of the Pelvic Floor and Functional Outcomes in patients who underwent Rectal Cancer Treatment - EFFORT trial

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON55378
Enrollment
46
Registered
2019-11-19
Start date
2020-02-12
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic floor function rectal cancer

Interventions

None listed

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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 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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
- 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.—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)