Early Pelvic Floor Muscle Training Improves Pelvic Floor... | NCT01146769

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

NCT01146769

Sponsor

Kwong Wah Hospital

Status

Unknown status

Last Update Posted

Jun 22, 2010Estimated

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Cancer of Rectum

Interventions

Pelvic floor exercise

Countries

Hong Kong

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Oct 2011Estimated

Completion Date

Apr 2012Estimated

First Submitted Date

Jun 15, 2010

First Submission Date that Met QC Criteria

Jun 17, 2010

First Posted Date

Jun 22, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 17, 2010

Last Update Posted Date

Jun 22, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pelvic floor exercise	Experimental		Other: Pelvic floor exercise
Control	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pelvic floor exercise	Other	Pelvic floor strengthening exercise	Pelvic floor exercise

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Patrick Y LAU, MBBS	Contact	(852) 3517 7919		lauyy01@ha.org.hk

Overall Officials

Name	Affiliation	Role
Patrick Y LAU	Department of Surgery, Kwong Wah Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Surgery, Kwong Wah Hospital	Recruiting	Hong Kong			Hong Kong

Condition Browse Module

MeSH Terms

ID	Term
D012004	Rectal Neoplasms

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided