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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00012932
Enrollment
142
Registered
2017-09-22
Start date
2018-01-01
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

C20 R15

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
Lead Sponsor

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

MeasureTime 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

MeasureTime 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

jonasfriedrich.schiemer@unimedizin-mainz.de06131 170

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026