NCT03120104

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 19, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

April 19, 2017

Status Verified

April 1, 2017

Enrollment Period

1.5 years

First QC Date

April 5, 2017

Last Update Submit

April 18, 2017

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

  • 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

Study Arms (2)

Pre-intervention group

ACTIVE COMPARATOR

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

Post-intervention group

ACTIVE COMPARATOR

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

Interventions

pelvic floor muscle exercise before stoma closureOTHER

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

Pre-intervention group
pelvic floor muscle exercise after stoma closureOTHER

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

Post-intervention group

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Municipal Wanfang Hospital (Managed by Taipei Medical University)

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Pin Li

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pin Li

CONTACT

+886-988-259-482101476@w.tmu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2017

First Posted

April 19, 2017

Study Start

June 1, 2017

Primary Completion

December 1, 2018

Study Completion

February 1, 2019

Last Updated

April 19, 2017

Record last verified: 2017-04

Locations

TW(1)