Physical Exercise for Colorectal Cancer Patients After Transanal Total Mesorectal Excision

Not Applicable

• Conditions: Rectal Cancer
• Interventions: Other: pelvic floor muscle exercise before stoma closure; Other: pelvic floor muscle exercise after stoma closure

• Registration Number: NCT03120104
• Lead Sponsor: Taipei Medical University WanFang Hospital

Brief Summary

Fecal incontinence is common in patients with rectal cancer after surgery. Previous studies showed that pelvic floor muscle and external sphincter muscle training after stoma closure could improve the severity of incontinence and other fecal symptoms, but there is no study about the effects of pelvic floor muscle exercise intervention before stoma closure. We are wondering would the symptom of fecal incontinence recover sooner and better if we give the pelvic floor muscle exercise intervention before the stoma closure. This article aims at comparing the effects of pelvic floor muscle training before stoma closure on fecal incontinence (pre-intervention group) with pelvic floor muscle training after stoma closure (post-intervention group), and we hypothesise that the severity of fecal incontinence will improve sooner and better in pre-intervention group.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-04
• Study First Submitted: 2017-04-05
• Study First Submitted QC: 2017-04-18
• Last Update Submitted: 2017-04-18
• Study First Posted: 2017-04-19
• Last Update Posted: 2017-04-19
• Study Start: 2017-06
• Primary Completion: 2018-12
• Study Completion: 2019-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• rectal cancer patients who have received transanal total mesorectal excision(TaTME) surgery; 20~75 years old

Exclusion Criteria

• terminal stage of cancer; unable to following orders due to poor cognitive condition; too weak to follow the experimental procedures; central nervous system lesions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pre-intervention group	pelvic floor muscle exercise before stoma closure	Pre-intervention group interventions:pelvic floor muscle training for one month (2\~3 times a week, for 4 weeks) just one month before the stoma closure
Post-intervention group	pelvic floor muscle exercise after stoma closure	Post-intervention group: pelvic floor muscle training for one month (2\~3 times a week, for 4 weeks) two weeks after the stoma closure

Primary Outcome Measures

Name	Time	Method
Change of The Wexner Score	measurement point 1: 2 weeks after the stoma closure; measurement point 2: 1 month after the intervention start	for the change of severity of fecal incontinence assessment

Secondary Outcome Measures

Name	Time	Method
Change of Functional assessment of Cancer Therapy - Colorectal (FACT-C)	measurement point 1: 2 weeks after the stoma closure; measurement point 2: 1 month after the intervention start	for the change of quality of life assessment
Change of St. Mark's Hospital Incontinence Score	measurement point 1: 2 weeks after the stoma closure; measurement point 2: 1 month after the intervention start	for the change of severity of fecal incontinence assessment

Trial Locations

Locations (1)

Taipei Municipal Wanfang Hospital (Managed by Taipei Medical University); 🇨🇳 Taipei, Taiwan