Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000367943
Ethics application status
Approved
Date submitted
26/03/2011
Date registered
11/04/2011
Date last updated
11/04/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
To predict a breakdown in the joint of the two ends of the bowel after bowel resection surgery.
Scientific title
"A pilot study to predict anastomotic leak in the breakdown in the joint of the two ends of the bowel after bowel resection surgery".
Secondary ID [1] 259864 0
NIl
Universal Trial Number (UTN)
U1111-1120-3029
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anastomotic leak 265446 0
Condition category
Condition code
Surgery 265606 265606 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
To detect if a drop in flux(blood flow) as measured by the laser doppler rectal probe predicts anastomotic leak.Participants recruited over 2 years. And the outcome which is leak will be observed post operatively.
Intervention code [1] 264285 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 262392 0
To predict anastomotic leak in patients undergoing low anterior resection using laser doppler rectal probe.
Methods used 1. Clinical 2.Evidence of leak suggested by Ct scan
Timepoint [1] 262392 0
Post operative period.Weekly from day1 to 16 weeks.
Secondary outcome [1] 273691 0
Reoperation rates for anastomotic leaks.
Timepoint [1] 273691 0
Day1 to 16weeks post operation.
Secondary outcome [2] 273784 0
Radiotherapy Vs No Radiotherapy
Timepoint [2] 273784 0
Day 1 to 16 weeks
Secondary outcome [3] 273785 0
Length of stay for patients who had a leak by reviewing discharge summary.
Timepoint [3] 273785 0
Day 1 to 16weeks
Secondary outcome [4] 273786 0
Ileus rates post surgery ( clinical assessment)
Timepoint [4] 273786 0
Day 1 to 16 weeks
Secondary outcome [5] 273787 0
Surgical site infection-Clinical assessment
Timepoint [5] 273787 0
Day 1 to 16 weeks
Secondary outcome [6] 273788 0
Impact (Protein drink) Vs No Impact in the leak group by reviewing patient records.
Timepoint [6] 273788 0
Day 1 to 6 weeks

Eligibility
Key inclusion criteria
Open and laparoscopic anterior resection
Standardised operative technique
Hand sewn or stapled anastomosis
Elective Surgery
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Emergency Surgery
Unable to Consent

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264741 0
Hospital
Name [1] 264741 0
John Hunter Hospital
Country [1] 264741 0
Australia
Primary sponsor type
Individual
Name
Dr Stephen Smith
Address
Suite G7 Newcastle Hospital Private Suites, New Lambton Heights, NSW, 2305
Country
Australia
Secondary sponsor category [1] 263865 0
Individual
Name [1] 263865 0
Anil Koshy
Address [1] 263865 0
Suite G7 Newcastle Hospital Private Suites, New Lambton Heights, NSW, 2305
Country [1] 263865 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266727 0
Hunter New England Human Research Ethics Committee,
Ethics committee address [1] 266727 0
Hunter New England Research Ethics and Governance Unit
Administration, Ground Floor
Lookout Road
New Lambton, NSW 2305
Ethics committee country [1] 266727 0
Australia
Date submitted for ethics approval [1] 266727 0
Approval date [1] 266727 0
18/02/2009
Ethics approval number [1] 266727 0
EC00144

Summary
Brief summary
Colorectal anastomosis /joins in the colon following surgery leak around 2%. From previous studies we are aware that the most important reason being decreased blood supply. To this date there are lots of studies looking at how to detect anastomotic leaks, But very few studies in predicting anastomotic leak. We believe a prospective study which involves measuring blood flow with the help of rectal laser doppler probe used preoperatively and then post operatively will help us in predicting which anastomosis are more prone to leak. The proposed study is a non-randomised study.All participants who are considered for bowel anastomosis at the participating hospital will comprise the study sample. After obtaining an informed consent from the participants the study will be conducted. The laser doppler flowmetry is a well established method for providing non-invasive real time measurements of blood flow within local tissue
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32393 0
Address 32393 0
Country 32393 0
Phone 32393 0
Fax 32393 0
Email 32393 0
Contact person for public queries
Name 15640 0
STEVE SMITH
Address 15640 0
G7 Newcastle Private medical suite
New Lambton heights
Newcastle
NSW 2305
Country 15640 0
Australia
Phone 15640 0
+61 2 49855568
Fax 15640 0
+61 2 49563246
Email 15640 0
steve_srs@hotmail.com
Contact person for scientific queries
Name 6568 0
STEVE SMITH
Address 6568 0
G7 Newcastle Private medical suite
New Lambton heights
Newcastle
NSW 2305
Country 6568 0
Australia
Phone 6568 0
+61 24 9855568
Fax 6568 0
+61 2 49563246
Email 6568 0
steve_srs@hotmail.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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