Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000082606
Ethics application status
Approved
Date submitted
31/07/2005
Date registered
5/08/2005
Date last updated
1/06/2024
Date data sharing statement initially provided
16/07/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
INSTEP Trial
Scientific title
Influence of NSAID on Short Term Efficacy of Pleurodesis for recurrent pneumothorax
Secondary ID [1] 287944 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
INSTEP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recurrent or persistent pneumothorax requiring VATS pleurodesis 160 0
Condition category
Condition code
Respiratory 178 178 0 0
Other respiratory disorders / diseases
Surgery 179 179 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Celebrex 200mg bd 5 days
Intervention code [1] 80 0
Treatment: Drugs
Comparator / control treatment
Placebo bd 5 days
Control group
Placebo

Outcomes
Primary outcome [1] 215 0
Rate of persistent air leak, pleural space problems or recurrent pneumothorax after VATS pleurodesis.
Timepoint [1] 215 0
7 days
Secondary outcome [1] 495 0
Total analgesic usage.
Timepoint [1] 495 0
7 days
Secondary outcome [2] 496 0
Drug-related complications.
Timepoint [2] 496 0
30 days
Secondary outcome [3] 497 0
Late recurrence of pneumothorax.
Timepoint [3] 497 0
2 years

Eligibility
Key inclusion criteria
Patients with surgical indication for pleurodesis due to recurrent or persistent pneumohtorax
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Chronic NSAID usage that cannot be stopped for more than 24 hours prior to surgery.
Renal impairment

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)
Centrally held master list (hospital pharmacy)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated, no stratification or blocking
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2004
Actual
15/12/2004
Date of last participant enrolment
Anticipated
30/06/2024
Actual
Date of last data collection
Anticipated
30/09/2024
Actual
Sample size
Target
100
Accrual to date
100
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 4694 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Funding & Sponsors
Funding source category [1] 234 0
Self funded/Unfunded
Name [1] 234 0
University grant
Country [1] 234 0
Primary sponsor type
Individual
Name
Gavin M Wright
Address
Cardiothoracic Research Office
St Vincent's Hospital (Melbourne)
41 Victoria Parade
Fitzroy VIC 3065
Country
Australia
Secondary sponsor category [1] 174 0
None
Name [1] 174 0
N/A
Address [1] 174 0
Country [1] 174 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1033 0
St Vincent's Hospital, Melbourne
Ethics committee address [1] 1033 0
41 Victoria Parade
Fitzroy VIC 3065
Ethics committee country [1] 1033 0
Australia
Date submitted for ethics approval [1] 1033 0
Approval date [1] 1033 0
01/05/2024
Ethics approval number [1] 1033 0
Ethics committee name [2] 1034 0
St Vincent's and Mercy Private Hospital
Ethics committee address [2] 1034 0
59 Victoria Parade
Fitzroy VIC 3065
Ethics committee country [2] 1034 0
Australia
Date submitted for ethics approval [2] 1034 0
Approval date [2] 1034 0
30/01/2006
Ethics approval number [2] 1034 0

Summary
Brief summary
For pain relief after VATS pleurodesis, patients are given either Celebrex or Placebo for 5 days plus any other required analgesics. We aim to determine whether there is any difference in failure of the lung to adhere to the lining of the chest.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35486 0
A/Prof Gavin M Wright
Address 35486 0
Cardiothoracic Research Office
4th Floor Inpatient Services Building
St Vincent's Hospital
41 Victoria Parade
Fitzroy VIC 3065
Country 35486 0
Australia
Phone 35486 0
+61 3 9419 2477
Fax 35486 0
Email 35486 0
[email protected]
Contact person for public queries
Name 9269 0
Ms Jane Mack
Address 9269 0
St Vincents's Hospital Melbourne
5th Floor
55 Victoria Parade
Fitzroy VIC 3065
Country 9269 0
Australia
Phone 9269 0
+61 3 92884616
Fax 9269 0
+61 3 9288 4615
Email 9269 0
[email protected]
Contact person for scientific queries
Name 197 0
A/Prof Gavin M Wright
Address 197 0
St Vincents's Hospital Melbourne
5th Floor
55 Victoria Parade
Fitzroy VIC 3065
Country 197 0
Australia
Phone 197 0
+61 3 94192477
Fax 197 0
+61 3 93171694
Email 197 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.