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Trial registered on ANZCTR


Registration number
ACTRN12606000199516
Ethics application status
Approved
Date submitted
27/03/2006
Date registered
26/05/2006
Date last updated
26/05/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Trial of colonic stenting for large bowel obstruction
Scientific title
Surgery versus stent insertion for the improved quality of life for non-curable colorectal cancer - large bowel obstruction
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal cancers 1176 0
Large bowel obstructions 1177 0
Condition category
Condition code
Cancer 1260 1260 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will compare the outcomes of colorectal surgery (bowel resection and possible stoma formation) versus colonic stent insertion using Ultraflex or Wallfex Precision Colonic Stent manufactured by Boston Scientific (TGA approved in Australia) to determine optimal management of non-curable colorectal cancer. Comparisons will be made between quality of life, length of stay, complications and cost to identify which group has the optimal outcome. The study will be conducted over 3 years.
Intervention code [1] 958 0
Treatment: Surgery
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 1698 0
To compare quality of life between surgical intervention and colonic stent insertion in the first 12 months following the procedure.
Timepoint [1] 1698 0
Daily until discharge from hospital, then at 1, 2, and 4 weeks and 3, 6 and 12 months
Secondary outcome [1] 3040 0
1. Permanent stoma rate
Timepoint [1] 3040 0
Immediately postoperative
Secondary outcome [2] 3041 0
2. length of procedure
Timepoint [2] 3041 0
Immediately postoperatively
Secondary outcome [3] 3042 0
3. length of intensive care
Timepoint [3] 3042 0
Postoperatively until discharge form intensive care
Secondary outcome [4] 3043 0
4. length of hospital stay
Timepoint [4] 3043 0
Admission to discharge
Secondary outcome [5] 3044 0
5. complication rate
Timepoint [5] 3044 0
Admission to discharge
Secondary outcome [6] 3045 0
6. 30 day mortality rate
Timepoint [6] 3045 0
Admission to 30 days post procedure
Secondary outcome [7] 3046 0
7. cost utility
Timepoint [7] 3046 0
Admission to discharge

Eligibility
Key inclusion criteria
All adult patients who present with malignant large bowel obstruction proven radiologically & deemed non-curable by surgical interention.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
If a patient is unfit for surgical iintervention (ASA grade iv & v), require urgent laparotomy due to perferation or ischaemia of the bowel, have evidence of synchronous & seperate sites of the small & large bowel, or are cognitively impaired or otherwise unable to give informed consent.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation by usiong a randomisation table created by computer software ( computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Phase 1
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1378 0
Government body
Name [1] 1378 0
NH & MRC project grant
Address [1] 1378 0
Country [1] 1378 0
Australia
Primary sponsor type
Individual
Name
Dr Christopher Young
Address
Country
Secondary sponsor category [1] 1213 0
None
Name [1] 1213 0
nil
Address [1] 1213 0
Country [1] 1213 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2731 0
Research Development Office Royal Prince Alfred Hospital
Ethics committee address [1] 2731 0
Level 8, Building 14, Royal Prince Alfred Hospital, Camperdown NSW 2050
Ethics committee country [1] 2731 0
Australia
Date submitted for ethics approval [1] 2731 0
Approval date [1] 2731 0
Ethics approval number [1] 2731 0

Summary
Brief summary
For patients with malignant bowel obstruction that cannot be cured, palliative surgery is often required to relieve the obstruction. This usually requires the formation of a stoma or opening where the bowel is brought to the suface of the skin. An alternative to surgery is the placement of a metal tube or stent through the obstruction to allow the passage of stool. As these surgical interventions are palliative the most important outcomes are those relating to the patients quality of life. This study will determine whether patients' quality of life is greater following stent insertion than surgery to relieve bowel obstruction. It will also compare complication rates and resource utilisation for each intervention. An economic evaluation will determine the relative cost-effectiveness of the 2 procedures.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36356 0
Address 36356 0
Country 36356 0
Phone 36356 0
Fax 36356 0
Email 36356 0
Contact person for public queries
Name 10147 0
Christine Merlino
Address 10147 0
Colorectal Research Department
Royal Prince Alfred Hospital
c/o 9W1
Missenden Rd
Camperdown NSW 2050
Country 10147 0
Australia
Phone 10147 0
+61 2 9515 7256
Fax 10147 0
+61 2 9515 5332
Email 10147 0
colorectal@email.cs.nsw.gov.au
Contact person for scientific queries
Name 1075 0
Dr Christopher Young
Address 1075 0
Royal Prince Alfred Hospital Medical Centre
Missenden Rd
Camperdown NSW 2050
Country 1075 0
Australia
Phone 1075 0
+61 2 9519 7576
Fax 1075 0
+61 2 9519 1806
Email 1075 0
cyoung@aol.com

No information has been provided regarding IPD availability
Summary results
No Results