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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23744

Enrollment

Registered

2019-10-31

Start date

2020-01-02

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Patients after Low anterior resection and/or (chemo)radition

Interventions

Questionnairres and anal measuremnet with a probe of the EMG signals of the pelvic floor

Eligibility

Inclusion criteria

Inclusion criteria: To be eligible to participate in this study, a subject must meet all the following criteria: - The patient underwent treatment for rectal cancer by LAR, LAR preceded by SCRT, LAR preceded by CRT or CRT alone in the period January 2015 till December 2017. - > 18 years of age. - Proficiency of the Dutch language. - Able and willing to read and fill in questionnaires. - Written informed consent.

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Patients who underwent abdomino- perineal resection (APR) or Hartman resection. - Patients with a diverting colostoma. - Neurological comorbidity (spinal lesion 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

Measure	Time frame
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 2015 till December 2017.	—

Secondary

Measure	Time frame
1) To compare EMG values of the pelvic floor after rectal cancer treatment between different treatment groups (LAR, LAR preceded by Short Course Radiotherapy (SCRT), LAR preceded by chemoradiotherapy (CRT), or CRT alone). - 2) To compare functional outcome after rectal cancer treatment between different treatment groups (LAR, LAR preceded by Short Course Radiotherapy (SCRT), LAR preceded by chemoradiotherapy (CRT), or CRT alone). - 3) To determine a correlation between EMG values of the pelvic floor after (chemo)radiotherapy of the rectum and the radiation dose to the different individual muscles of the pelvic floor. Stu	—

Measure

Time frame

1) To compare EMG values of the pelvic floor after rectal cancer treatment between different treatment groups (LAR, LAR preceded by Short Course Radiotherapy (SCRT), LAR preceded by chemoradiotherapy (CRT), or CRT alone). - 2) To compare functional outcome after rectal cancer treatment between different treatment groups (LAR, LAR preceded by Short Course Radiotherapy (SCRT), LAR preceded by chemoradiotherapy (CRT), or CRT alone). - 3) To determine a correlation between EMG values of the pelvic floor after (chemo)radiotherapy of the rectum and the radiation dose to the different individual muscles of the pelvic floor. Stu

—

Contacts

Public ContactPetra J. Voorham= van der Zalm

Leiden University Medical Center, Department of Urology

pjvoorham@lumc.nl+31 71526 3888

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)