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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01146769
Other study ID # EMTIMS-01
Secondary ID
Status Recruiting
Phase N/A
First received June 15, 2010
Last updated June 17, 2010
Start date April 2010
Est. completion date April 2012

Study information

Verified date April 2010
Source Kwong Wah Hospital
Contact Patrick Y LAU, MBBS
Phone (852) 3517 7919
Email lauyy01@ha.org.hk
Is FDA regulated No
Health authority Hong Kong: Ethics Committee
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date April 2012
Est. primary completion date October 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Pelvic floor exercise
Pelvic floor strengthening exercise

Locations

Country Name City State
Hong Kong Department of Surgery, Kwong Wah Hospital Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
Kwong Wah Hospital

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum Squeeze Pressure 1 week before operation and 3 months after operation No
Secondary Functional Outcomes Bowel frequency, Fecal incontinence score 1 week before operation and 3 months post operation No
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