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Early Pelvic Floor Muscle Training Improves Pelvic Floor Muscle Strength in Patient After Low Anterior Resection

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Kwong Wah Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Kwong Wah Hospital
ClinicalTrials.gov Identifier:
NCT01146769
First received: June 15, 2010
Last updated: June 17, 2010
Last verified: April 2010
  Purpose

The aim of study is to investigate the difference in Maximum Squeeze Pressure in patients with and without pelvic floor muscle training in low anterior resection in peri-operative period


Condition Intervention
Cancer of Rectum
Other: Pelvic floor exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Early Pelvic Floor Muscle Training Improves Pelvic Floor Muscle Strength in Patient After Low Anterior Resection

Resource links provided by NLM:


Further study details as provided by Kwong Wah Hospital:

Primary Outcome Measures:
  • Maximum Squeeze Pressure [ Time Frame: 1 week before operation and 3 months after operation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional Outcomes [ Time Frame: 1 week before operation and 3 months post operation ] [ Designated as safety issue: No ]
    Bowel frequency, Fecal incontinence score


Estimated Enrollment: 50
Study Start Date: April 2010
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pelvic floor exercise Other: Pelvic floor exercise
Pelvic floor strengthening exercise
No Intervention: Control

Detailed Description:

The functional outcome after low anterior resection varies greatly. Proportion of patient suffers from urgency and incontinence. Pelvic muscle disuse with atrophy and fibrosis may be a cause for the poor function. Peri-operative pelvic floor muscle training may preserve pelvic floor muscle bulk and function and thus improve functional outcome after surgery.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who will undergo low anterior resection of rectum
  • Patient consented for study

Exclusion Criteria:

  • Patient unable to understand pelvic floor exercise
  • Patient who underwent alternative procedure
  • Patient who suffers anastomotic complications after surgery
  • Patient who ileostomy not closed
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01146769

Contacts
Contact: Patrick Y LAU, MBBS (852) 3517 7919 lauyy01@ha.org.hk

Locations
Hong Kong
Department of Surgery, Kwong Wah Hospital Recruiting
Hong Kong, Hong Kong
Contact: Patrick Lau       lauyy01@ha.org.hk   
Sponsors and Collaborators
Kwong Wah Hospital
Investigators
Principal Investigator: Patrick Y LAU Department of Surgery, Kwong Wah Hospital
  More Information

No publications provided

Responsible Party: LAU Patrick YY, Department of Surgery, Kwong Wah Hospital
ClinicalTrials.gov Identifier: NCT01146769     History of Changes
Other Study ID Numbers: EMTIMS-01
Study First Received: June 15, 2010
Last Updated: June 17, 2010
Health Authority: Hong Kong: Ethics Committee

Keywords provided by Kwong Wah Hospital:
Cancer of rectum
Physiotherapy

ClinicalTrials.gov processed this record on November 19, 2014