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

June 17, 2010 updated by: Kwong Wah Hospital
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

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 Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Department of Surgery, Kwong Wah Hospital
        • Contact:

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control
EXPERIMENTAL: Pelvic floor exercise
Other: Pelvic floor exercise
Pelvic floor strengthening exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum Squeeze Pressure
Time Frame: 1 week before operation and 3 months after operation
1 week before operation and 3 months after operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Outcomes
Time Frame: 1 week before operation and 3 months post operation
Bowel frequency, Fecal incontinence score
1 week before operation and 3 months post operation

Collaborators and Investigators

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

Sponsor

Kwong Wah Hospital

Investigators

  • Principal Investigator: Patrick Y LAU, Department of Surgery, Kwong Wah Hospital

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

April 1, 2010

Primary Completion (ANTICIPATED)

October 1, 2011

Study Completion (ANTICIPATED)

April 1, 2012

Study Registration Dates

First Submitted

June 15, 2010

First Submitted That Met QC Criteria

June 17, 2010

First Posted (ESTIMATE)

June 22, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

June 22, 2010

Last Update Submitted That Met QC Criteria

June 17, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMTIMS-01

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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