Physical Exercise for Colorectal Cancer Patients After Transanal Total Mesorectal Excision

Rectal Cancer Clinical Trial

Official title:

Physical Exercise for Colorectal Cancer Patients After Transanal Total Mesorectal Excision

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03120104
• Other study ID #: N201610007
• Status: Recruiting
• Phase: N/A
• First received: April 5, 2017
• Last updated: April 18, 2017
• Start date: June 2017
• Est. completion date: February 2019

Study information

• Verified date: April 2017
• Source: Taipei Medical University WanFang Hospital
• Contact: Pin Li
• Phone: +886-988-259-482
• Email: 101476[@]w.tmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Rectal Cancer
• Rectal Neoplasms

Intervention

Other:
• pelvic floor muscle exercise before stoma closure
pelvic floor muscle training for one month (2~3 times a week, for 4 weeks) just one month before the stoma closure
• pelvic floor muscle exercise after stoma closure
pelvic floor muscle training for one month (2~3 times a week, for 4 weeks) just two weeks after the stoma closure

Locations

Country	Name	City	State
Taiwan	Taipei Municipal Wanfang Hospital (Managed by Taipei Medical University)	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University WanFang Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of The Wexner Score	for the change of severity of fecal incontinence assessment	measurement point 1: 2 weeks after the stoma closure; measurement point 2: 1 month after the intervention start
Secondary	Change of St. Mark's Hospital Incontinence Score	for the change of severity of fecal incontinence assessment	measurement point 1: 2 weeks after the stoma closure; measurement point 2: 1 month after the intervention start
Secondary	Change of Functional assessment of Cancer Therapy - Colorectal (FACT-C)	for the change of quality of life assessment	measurement point 1: 2 weeks after the stoma closure; measurement point 2: 1 month after the intervention start