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Trial registered on ANZCTR


Registration number
ACTRN12614000349640
Ethics application status
Not yet submitted
Date submitted
24/03/2014
Date registered
1/04/2014
Date last updated
1/04/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Topical Glyceryl Trinitrate vs placebo in reducing perioperative pain and analgesic requirements in haemorrhoid banding
Scientific title
In those undergoing elective colonoscopy + banding of haemorrhoids, how does use of topical Glyceryl Trinitrate prior to banding versus placebo prior to banding, affect pain and analgesic requirements in the perioperative setting
Secondary ID [1] 284032 0
Nil
Universal Trial Number (UTN)
U1111-1152-9981
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Haemorrhoids 291081 0
pain 291082 0
Condition category
Condition code
Surgery 291426 291426 0 0
Surgical techniques
Anaesthesiology 291427 291427 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will have a standard dose of Gylceryl Trinitrate (standard dose = 1.5cm strip of the product where the active ingredient = 0.2% glyceryl trinitrate) applied to the perianal region immediately prior to haemorrhoid banding.
Intervention code [1] 288723 0
Treatment: Drugs
Comparator / control treatment
placebo
The placebo is made of all the ingredients within the treatment ointment apart from glyceryl trinitrate. Specifically ethanol which is used to dissolve the active ingredient in the treatment ointment will remain in the placebo.
Control group
Placebo

Outcomes
Primary outcome [1] 291413 0
Pain scores:

This will be assessed in the post operative period by the anaesthetic nurses who will assess VAS (Visual Analogue Scale) at 10mins, 30mins and 60mins post operatively as per standard anaesthetic protocol post operatively.

In addition patients will fill a questionnaire before leaving following their procedure where they are asked to rate "anal pain" out of 10 and "general pain" out of 10 (where 1 is labelled as virtually no pain and 10 is labelled as "worst pain possible".)

Patients will hand in the questionnaires prior to leaving.
Timepoint [1] 291413 0
in the perioperative period (within 1 hr post haemorrhoid banding)
Secondary outcome [1] 306717 0
Perioperative analgesic requirement
The anaesthetic charts will be reviewed. The type of medication and the total dosing will be recorded for
1) pre-medication,
2) during procedure medication
3) post procedure medication (within the 60mins post operative period)
Timepoint [1] 306717 0
in the perioperative period (within 1hr post haemorrhoid banding)
Secondary outcome [2] 307578 0
Complications of intervention
The most common side effect of the intervention is listed as headache and hence patients will be asked to fill out a questionnaire where they are asked to circle yes or no to having a headache in the post operative period.
Timepoint [2] 307578 0
within 60mins of procedure
Secondary outcome [3] 307579 0
Colonoscopy findings will be determined
Following the procedure the Surgeon will fill out a form detailing relevant findings in the colonoscope; Specifically they will fill out a form asking

List the pertinent colonoscopy findings (there will be blank box where the surgeon lists the findings)

List the haemorrhoid findings: (grade:, number:, treatment given:)

Other deal: (if haemorrhoid banding not completed, why not?. Were there any complications?)
Timepoint [3] 307579 0
this represents the operative findings and the surgeon will complete this immediately following the procedure

Eligibility
Key inclusion criteria
those undergoing elective colonoscopy + haemorrhoid banding
Minimum age
15 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
allergies or contraindications to using glyceryl trinitrate

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)
The surgeon will discuss the trial with all patients being booked for elective colonoscopy + haemorrhoid banding. If patient agrees to trial, after consenting the patient, the patient will be booked for theatre. At operation, before banding, the surgeon will apply a standard topical dose of ointment from a blinded tube/bottle. This tube/bottle will be in a numbered container. This will contain either active ingredient of placebo. The only identifiable factor on the tube will be a serial number. The serial number will be listed in a book (off site) which lists if the serial number equates to a tube containing active ingredient of placebo.

Containers will be numbered
Central randomisation will be completed using a computer
An offsite member of the team will hold the allocation schedule
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random number generator will generate the serial numbers. The tubes are only identifiable by a serial number. The tubes are identical in appearance and contain either placebo or active ingredient. To select the tube, the scrub nurse will select a tube at random from all the tubes (kept within a box). The serial number of the tube will be written down by the surgeon onto a case file for that patient.
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
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
sample size will be determined following a pilot study

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/04/2014
Actual
Date of last participant enrolment
Anticipated
13/06/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 2233 0
Calvary Private Hospital - Wagga Wagga
Recruitment postcode(s) [1] 7912 0
2650 - Wagga Wagga

Funding & Sponsors
Funding source category [1] 288967 0
Self funded/Unfunded
Name [1] 288967 0
Country [1] 288967 0
Primary sponsor type
Individual
Name
Stephen Jancewicz
Address
11 Gormley Avenue, Wagga Wagga NSW 2650
Country
Australia
Secondary sponsor category [1] 287648 0
Commercial sector/Industry
Name [1] 287648 0
Care Pharmaceuticals
Address [1] 287648 0
Suite 302, Level 3, 75 Grafton Street, Bondi Junction NSW 2022
Country [1] 287648 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 290778 0
Calvary Hospital Ethics Committee
Ethics committee address [1] 290778 0
Ethics committee country [1] 290778 0
Australia
Date submitted for ethics approval [1] 290778 0
02/04/2014
Approval date [1] 290778 0
Ethics approval number [1] 290778 0

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

Contacts
Principal investigator
Name 46030 0
Dr Hamish Urquhart
Address 46030 0
Hamish Urquhart is a General Surgical Registrar working at Royal North Shore Hospital. His address is:
57 Ulundri Drive, Castle Hill NSW 2154
Country 46030 0
Australia
Phone 46030 0
+61 408653789
Fax 46030 0
Email 46030 0
hurquhart@med.usyd.edu.au
Contact person for public queries
Name 46031 0
Hamish Urquhart
Address 46031 0
Hamish Urquhart is a General Surgical Registrar working at Royal North Shore Hospital. His address is:
57 Ulundri Drive, Castle Hill NSW 2154
Country 46031 0
Australia
Phone 46031 0
+61 408653789
Fax 46031 0
Email 46031 0
hurquhart@med.usyd.edu.au
Contact person for scientific queries
Name 46032 0
Hamish Urquhart
Address 46032 0
Hamish Urquhart is a General Surgical Registrar working at Royal North Shore Hospital. His address is:
57 Ulundri Drive, Castle Hill NSW 2154
Country 46032 0
Australia
Phone 46032 0
+61 408653789
Fax 46032 0
Email 46032 0
hurquhart@med.usyd.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.