Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000299606
Ethics application status
Approved
Date submitted
29/08/2005
Date registered
5/09/2005
Date last updated
25/08/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improving intestinal function after surgery
Scientific title
A prospective, randomised, double-blind, controlled trial examining the effects of prostaglandin inhibition on outcomes after intestinal surgery.
Universal Trial Number (UTN)
Trial acronym
POINT study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cessation of intestinal motor function post gastrointestinal surgery 387 0
Condition category
Condition code
Surgery 458 458 0 0
Other surgery
Oral and Gastrointestinal 459 459 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
3 study groups; placebo, Diclofenac, Celecoxib given as a preoperative dose and continued until discharge, or 7 days postoperatively. All patients receive Pantoprazole 40 mg daily.
Intervention code [1] 289 0
None
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 519 0
Time from operation to passage of flatus and faeces
Timepoint [1] 519 0
once daily post surgery for a week
Primary outcome [2] 520 0
Resumption of liquid and solid food intake
Timepoint [2] 520 0
once daily post surgery for a week
Secondary outcome [1] 1113 0
Postoperative vomiting, nasogastric tube usage (and losses per tube if inserted).
Timepoint [1] 1113 0
daily post surgery for a week
Secondary outcome [2] 1114 0
Postoperative renal function
Timepoint [2] 1114 0
Measured days 1,3,5
Secondary outcome [3] 1115 0
Blood loss or perioperative bleeding.
Timepoint [3] 1115 0
daily post surgery for a week

Eligibility
Key inclusion criteria
Patients underoing gastrointestinal surgery that involves intestinal manipulation (chiefly colorectal surgery). No recent history of gastrointestinal ulceration, intolerance to nonsteriodal antiflammatory drugs. Creatinine clearance greater than 30 ml/min. No requirement for postoperative ACE inhibitors.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
renal dysfuction, asthma, anticoagulants

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)
All study drugs packaged and numbered in the pharmacy department - inserted into uniform gelatin capsules.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated and stratification applies
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/01/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 510 0
Self funded/Unfunded
Name [1] 510 0
Country [1] 510 0
Primary sponsor type
Hospital
Name
Department of Gastrointestinal Surgery, Flinders Medical Centre
Address
Bedford Park, SA., 5042
Country
Australia
Secondary sponsor category [1] 418 0
Hospital
Name [1] 418 0
Department of Gastroenterology, Flinders Medical Centre
Address [1] 418 0
Bedford Park, SA., 5042
Country [1] 418 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1489 0
Flinders Medical Centre
Ethics committee address [1] 1489 0
Ethics committee country [1] 1489 0
Australia
Date submitted for ethics approval [1] 1489 0
Approval date [1] 1489 0
Ethics approval number [1] 1489 0
Ethics committee name [2] 1490 0
Repatriation General Hospital
Ethics committee address [2] 1490 0
Ethics committee country [2] 1490 0
Australia
Date submitted for ethics approval [2] 1490 0
Approval date [2] 1490 0
Ethics approval number [2] 1490 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36391 0
Address 36391 0
Country 36391 0
Phone 36391 0
Fax 36391 0
Email 36391 0
Contact person for public queries
Name 9478 0
Dr David Wattchow
Address 9478 0
Department of Surgery
Flinders Medical Centre
Adelaide SA 5042
Country 9478 0
Australia
Phone 9478 0
+61 8 82044253
Fax 9478 0
+61 8 82045843
Email 9478 0
David.Wattchow@flinders.edu.au
Contact person for scientific queries
Name 406 0
Dr David Wattchow
Address 406 0
Department of Surgery
Flinders Medical Centre
Adelaide SA 5042
Country 406 0
Australia
Phone 406 0
+61 8 82044253
Fax 406 0
+61 8 82045843
Email 406 0
David.Wattchow@flinders.edu.au

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.