PIPE: Physiotherapeutic intervention with Pelvic Floor Muscle Training (PFMT) for Treatment of Low Anterior Resection Syndrome (LARS)

Not Applicable

• Conditions: C20; R15; Malignant neoplasm of rectum; Faecal incontinence

• Registration Number: DRKS00012932
• Lead Sponsor: niversitätsmedizin der Johannes Gutenberg-Universität Mainz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-22
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

Age > 18 years, TME surgery, histologically confirmed rectal cancer (= 12 cm from anal verge), informed consent, stoma closure.

Exclusion Criteria

severe untreated physical or mental impairment,
lack of compliance with the trial procedure,
present chemotherapy.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>

Secondary Outcome Measures

Name	Time	Method
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)