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Physical Exercise for Colorectal Cancer Patients After Transanal Total Mesorectal Excision

Primary Purpose

Rectal Cancer

Status

Unknown status

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

pelvic floor muscle exercise before stoma closure

pelvic floor muscle exercise after stoma closure

About this trial

This is an interventional treatment trial for Rectal Cancer

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Taipei Municipal Wanfang Hospital (Managed by Taipei Medical University)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Pre-intervention group

Post-intervention group

Arm Description

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 training for one month (2~3 times a week, for 4 weeks) two weeks after the stoma closure

Outcomes

Primary Outcome Measures

Change of The Wexner Score

for the change of severity of fecal incontinence assessment

Secondary Outcome Measures

Change of St. Mark's Hospital Incontinence Score

for the change of severity of fecal incontinence assessment

Change of Functional assessment of Cancer Therapy - Colorectal (FACT-C)

for the change of quality of life assessment

Full Information

NCT ID

NCT03120104

First Posted

April 5, 2017

Last Updated

April 18, 2017

Sponsor

Taipei Medical University WanFang Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03120104

Brief Title

Physical Exercise for Colorectal Cancer Patients After Transanal Total Mesorectal Excision

Official Title

Physical Exercise for Colorectal Cancer Patients After Transanal Total Mesorectal Excision

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Unknown status

Study Start Date

June 2017 (Anticipated)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

February 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Taipei Medical University WanFang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rectal Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pre-intervention group

Arm Type

Active Comparator

Arm Description

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

Arm Title

Post-intervention group

Arm Type

Active Comparator

Arm Description

Post-intervention group: pelvic floor muscle training for one month (2~3 times a week, for 4 weeks) two weeks after the stoma closure

Intervention Type

Other

Intervention Name(s)

pelvic floor muscle exercise before stoma closure

Intervention Description

pelvic floor muscle training for one month (2~3 times a week, for 4 weeks) just one month before the stoma closure

Intervention Type

Other

Intervention Name(s)

pelvic floor muscle exercise after stoma closure

Intervention Description

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

Primary Outcome Measure Information:

Title

Change of The Wexner Score

Description

for the change of severity of fecal incontinence assessment

Time Frame

measurement point 1: 2 weeks after the stoma closure; measurement point 2: 1 month after the intervention start

Secondary Outcome Measure Information:

Title

Change of St. Mark's Hospital Incontinence Score

Description

for the change of severity of fecal incontinence assessment

Time Frame

measurement point 1: 2 weeks after the stoma closure; measurement point 2: 1 month after the intervention start

Title

Change of Functional assessment of Cancer Therapy - Colorectal (FACT-C)

Description

for the change of quality of life assessment

Time Frame

measurement point 1: 2 weeks after the stoma closure; measurement point 2: 1 month after the intervention start

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pin Li

Phone

+886-988-259-482

101476@w.tmu.edu.tw

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pin Li

Organizational Affiliation

Rehabilitation Department of Taipei Municipal WanFang Hospitial (Managed by Taipei Medical University)

Official's Role

Principal Investigator

Facility Information:

Facility Name

Taipei Municipal Wanfang Hospital (Managed by Taipei Medical University)

City

Taipei

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pin Li

Phone

+886-988-259-482

101476@w.tmu.edu.tw

First Name & Middle Initial & Last Name & Degree

Pin Li

12. IPD Sharing Statement

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Physical Exercise for Colorectal Cancer Patients After Transanal Total Mesorectal Excision

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