Physical Exercise for Colorectal Cancer Patients After Transanal Total Mesorectal Excision

April 18, 2017 updated by: Taipei Medical University WanFang Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • Taipei Municipal Wanfang Hospital (managed by Taipei Medical University)
        • Contact:
        • Principal Investigator:
          • Pin Li

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pre-intervention group
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
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
Active Comparator: Post-intervention group
Post-intervention group: pelvic floor muscle training for one month (2~3 times a week, for 4 weeks) two weeks after the stoma closure
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of The Wexner Score
Time Frame: 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
measurement point 1: 2 weeks after the stoma closure; measurement point 2: 1 month after the intervention start

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of St. Mark's Hospital Incontinence Score
Time Frame: 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
measurement point 1: 2 weeks after the stoma closure; measurement point 2: 1 month after the intervention start
Change of Functional assessment of Cancer Therapy - Colorectal (FACT-C)
Time Frame: 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
measurement point 1: 2 weeks after the stoma closure; measurement point 2: 1 month after the intervention start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University WanFang Hospital

Investigators

  • Principal Investigator: Pin Li, Rehabilitation Department of Taipei Municipal WanFang Hospitial (Managed by Taipei Medical University)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2017

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

February 1, 2019

Study Registration Dates

First Submitted

April 5, 2017

First Submitted That Met QC Criteria

April 18, 2017

First Posted (Actual)

April 19, 2017

Study Record Updates

Last Update Posted (Actual)

April 19, 2017

Last Update Submitted That Met QC Criteria

April 18, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N201610007

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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