C20 R15
Conditions
Interventions
Group 1: Intervention Group: pelvic floor muscle Training by specialized physiotherapists for 3 months in 12 sessions with approximately 20 minutes.
Group 2: control group: no pelvic floor muscle tra
Sponsors
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age > 18 years, TME surgery, histologically confirmed rectal cancer (= 12 cm from anal verge), informed consent, stoma closure.
Exclusion criteria
Exclusion criteria: severe untreated physical or mental impairment, lack of compliance with the trial procedure, present chemotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is absolute change to baseline of LARS score (Low Anterior Resection Syndrome) 12 weeks after commencement of PFMT (Pelvic Floor Muscle Training). The LARS score evaluates bowel dysfunction. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives are absolute changes to baseline of LARS (Low Anterior Resection Syndrome) score 6, 18 and 24 weeks and of QLQ-C30 score (Quality of Life Questionnaire) 6, 12, 18 and 24 weeks after commencement of PFMT (Pelvic Floor Muscle Training) | — |
Countries
Germany
Contacts
Public ContactJonas Schiemer
Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Outcome results
None listed