gms | German Medical Science

Introduction: Low anterior resection for rectal cancer frequently results in severe bowel dysfunction known as Low anterior resection syndrome (LARS). Pelvic floor muscle training (PFMT) is a potential treatment option to improve patient’s functional outcome and quality of life (QoL). Since there are no previous studies available, we designed a randomized controlled study to assess the effects of PFMT by LARS and QoL questionnaires.

Method: PIPE is a prospective two-arm randomized controlled multicenter clinical trial comparing the functional outcome and quality of life in rectal cancer patients after total mesorectal excision (TME) and stoma closure with and without PFMT using the german evaluated versions of the LARS score and the EORTC QLQ-C30 QoL score (European Organization for Research and Treatment of Cancer, QoL Questionnaire). After stoma closure baseline evaluation with LARS and QLQ-C30 scores will be performed. The special physiotherapeutic intervention takes 12 weeks per patient, consisting of about 20 minutes PFMT per week. Follow-up period is 6 months per patient in total. Data collection after commencement of PFMT is after 6, 12, 18 and 24 weeks. With an assumed effect size of 0.5 and drop-out rate of 10%, a total of 142 patients will be necessary. Primary endpoint is absolute change to baseline in LARS score 12 weeks after commencement of PFMT. Secondary endpoints are absolute changes to baselines in LARS score 6, 18 and 24 weeks and in QLQ-C30 score 6, 12, 18 and 24 weeks after initiation of PFMT. For assessment of safety adverse events are acquired.

Results: The PIPE study will be performed according to The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and good clinical practice and the principles of the Declaration of Helsinki in its latest version. It is approved by the ethics committee of the State Chamber of Medicine Rhineland Palatinate, Germany with the number 837.270.17 (11104) of the University Medicine of the Johannes Gutenberg-University Mainz, Germany. The trial is registered at DRKS (Deutsches Register Klinischer Studien: DRKS00012932) and accredited by Study-Box. Several centers are currently willing to participate. However, funding is remaining.

Conclusion: LARS is common and affects patient’s QoL, but PFMT is no validated treatment option. Improving functional outcome and QoL of rectal cancer survivors is essential. Adequate assessment may be carried on the basis of the LARS and QLQ-C30 scores. The PIPE study will firstly evaluate PFMT against LARS in a randomized controlled multicenter approach.