Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610001000099
Ethics application status
Approved
Date submitted
23/06/2010
Date registered
17/11/2010
Date last updated
1/07/2019
Date data sharing statement initially provided
1/07/2019
Date results provided
1/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Use of local anaesthetics in hemorrhoid banding
Scientific title
In patients undergoing hemorrhoid banding does local anaesthetic injection
compared to no local anaesthetic reduce discomfort experienced during the
procedure
Secondary ID [1] 252085 0
Nil
Universal Trial Number (UTN)
U1111-1115-5898
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Haemorrhoids 257632 0
Condition category
Condition code
Surgery 257809 257809 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Local anaesthetic injections using 2-3ml of 0.5% bupivicaine injected in the haemorrhoidal mucosa immediately under the band at each site after application of the band. This procedure takes approximately 10-15 minutes.
Intervention code [1] 256709 0
Treatment: Drugs
Intervention code [2] 257625 0
Treatment: Surgery
Comparator / control treatment
No local anaesthetic injection (standard practice)
Control group
Active

Outcomes
Primary outcome [1] 258671 0
Pain scores using Visual Analogue Scale (VAS)
Timepoint [1] 258671 0
15 minutes, 1 hour and 24 hours following treatment (ie. banding with or without local anaesthetic)
Secondary outcome [1] 264666 0
Time to return to work by questioning at follow up clinic assessment
Timepoint [1] 264666 0
Clinic assessment at 6 weeks following procedure

Eligibility
Key inclusion criteria
Patients seen in outpatient clinic with hemorrhoids who would normally be
offered hemorrhoid banding
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with co-existing anorectal conditions
Patients with allergies to local anaesthetics
Patients on which banding is contraindicated

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)
Included patients will be randomized to procedures either with or without local
anaesthetics. The randomization assignment is concealed in the form of sealed
envelopes located with the suction banding device and is only revealed to the
clinician just prior to the procedure commencing.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation is generated by computer and the code is entered into the sealed
envelope described above
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
9/07/2009
Actual
2/09/2009
Date of last participant enrolment
Anticipated
Actual
7/12/2011
Date of last data collection
Anticipated
Actual
8/12/2011
Sample size
Target
120
Accrual to date
Final
72
Recruitment outside Australia
Country [1] 2720 0
New Zealand
State/province [1] 2720 0
Auckland

Funding & Sponsors
Funding source category [1] 257179 0
Hospital
Name [1] 257179 0
Department of general surgery Auckland City Hospital
Country [1] 257179 0
New Zealand
Primary sponsor type
Individual
Name
Ian Bissett
Address
Department of Surgery'
University of Auckland,
Private Bag 92019
Auckland, 1142
Country
New Zealand
Secondary sponsor category [1] 256435 0
Individual
Name [1] 256435 0
Henry Kwok
Address [1] 256435 0
Department of General Surgery
Auckland City Hospital
Park Road,
Grafton,
Auckland, 1023
Country [1] 256435 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259217 0
Northern X Regional Ethics Committee
Ethics committee address [1] 259217 0
Ethics committee country [1] 259217 0
New Zealand
Date submitted for ethics approval [1] 259217 0
Approval date [1] 259217 0
09/07/2009
Ethics approval number [1] 259217 0
NTX/09/04/029

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

Contacts
Principal investigator
Name 31328 0
A/Prof Ian Bissett
Address 31328 0
Department of Surgery University of Auckland, Private Bag 92019, Auckland 1142
Country 31328 0
New Zealand
Phone 31328 0
+64 9 3737599
Fax 31328 0
Email 31328 0
[email protected]
Contact person for public queries
Name 14575 0
Associate Professor Ian Bissett
Address 14575 0
Department of Surgery
University of Auckland,
Private Bag 92019,
Auckland 1142
Country 14575 0
New Zealand
Phone 14575 0
+64 9 3737599
Fax 14575 0
+64 9 3779656
Email 14575 0
[email protected]
Contact person for scientific queries
Name 5503 0
Associate Professor Ian Bissett
Address 5503 0
Department of Surgery
University of Auckland,
Private Bag 92019,
Auckland 1142
Country 5503 0
New Zealand
Phone 5503 0
+64 9 3737599
Fax 5503 0
+64 9 3779656
Email 5503 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
Study concluded 8 years ago and data no longer available


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.