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

• Sponsor: Kwong Wah Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01146769
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 24
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Cancer of Rectum	Other: Pelvic floor exercise	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Early Pelvic Floor Muscle Training Improves Pelvic Floor Muscle Strength in Patient After Low Anterior Resection
• Study Start Date: Apr 1, 2010
• Anticipated Primary Completion Date: Oct 1, 2011
• Anticipated Study Completion Date: Apr 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pelvic floor exercise	Other: Pelvic floor exercise; Pelvic floor strengthening exercise
No Intervention: Control

Outcome Measures

Primary Outcome Measures

1. Maximum Squeeze Pressure [1 week before operation and 3 months after operation]

Secondary Outcome Measures

1. Functional Outcomes [1 week before operation and 3 months post operation]

   Bowel frequency, Fecal incontinence score

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Department of Surgery, Kwong Wah Hospital	Hong Kong		Hong Kong

Sponsors and Collaborators

• Kwong Wah Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01146769
• Other Study ID Numbers: EMTIMS-01
• First Posted: Jun 22, 2010
• Last Update Posted: Jun 22, 2010
• Last Verified: Apr 1, 2010

• Keywords provided by , ,: Cancer of rectum; Physiotherapy
• Additional relevant MeSH terms: Rectal Neoplasms

Study Results

No Results Posted as of Jun 22, 2010