NCT01146769

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 22, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

June 22, 2010

Status Verified

April 1, 2010

Enrollment Period

1.5 years

First QC Date

June 15, 2010

Last Update Submit

June 17, 2010

Conditions

Cancer of Rectum

Keywords

Cancer of rectumPhysiotherapy

Outcome Measures

Primary Outcomes (1)

  • Maximum Squeeze Pressure

    1 week before operation and 3 months after operation

Secondary Outcomes (1)

  • Functional Outcomes

    1 week before operation and 3 months post operation

Study Arms (2)

Pelvic floor exercise

EXPERIMENTAL
Other: Pelvic floor exercise

Control

NO INTERVENTION

Interventions

Pelvic floor exerciseOTHER

Pelvic floor strengthening exercise

Pelvic floor exercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patient unable to understand pelvic floor exercise
  • Patient who underwent alternative procedure
  • Patient who suffers anastomotic complications after surgery
  • Patient who ileostomy not closed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery, Kwong Wah Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Patrick Y LAU

    Department of Surgery, Kwong Wah Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick Y LAU, MBBS

CONTACT

(852) 3517 7919lauyy01@ha.org.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 15, 2010

First Posted

June 22, 2010

Study Start

April 1, 2010

Primary Completion

October 1, 2011

Study Completion

April 1, 2012

Last Updated

June 22, 2010

Record last verified: 2010-04

Locations

HK(1)