Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000044921
Ethics application status
Approved
Date submitted
9/01/2020
Date registered
21/01/2020
Date last updated
21/12/2021
Date data sharing statement initially provided
21/01/2020
Date results information initially provided
21/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of 2 different medicated ointments with placebo for pain relief after banding of haemorrhoids.
Scientific title
A 3-arm Randomised, Double-blind, Placebo-controlled Trial of Lignocaine vs Lignocaine+Diltiazem vs Placebo Topical Ointments to Reduce Post-Procedural Pain in Patients Undergoing Haemorrhoidal Banding
Secondary ID [1] 300214 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
haemorrhoids 315775 0
Condition category
Condition code
Oral and Gastrointestinal 314060 314060 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The interventions consist of 3 different ointments:
-lignocaine 2% in polyethylene glycol (PEG) base or
-lignocaine 2% and diltiazem 2% in polyethylene glycol (PEG) base

A 2cm length of ointment will be digitally applied to the anal area 3 times per day for 5 days from the procedure. Each participant will record in a written diary that the ointment has been applied.
Intervention code [1] 316487 0
Treatment: Drugs
Comparator / control treatment
Ointment consisting of polyethylene glycol (PEG) base
Control group
Placebo

Outcomes
Primary outcome [1] 322455 0
Pain scores between the 3 arms will be assessed using a standardised 10-point patient reported continuous visual analogue scale (zero represented no pain at all, and ten represented the severest pain imaginable)
Timepoint [1] 322455 0
• 30 minutes
• 1 hour
• 6 hours
• 12 hours
• 24 hours
• 48 hours
Secondary outcome [1] 378589 0
Total opioid analgesic usage as reported by the patient in oral morphine milli-equivalents.
Timepoint [1] 378589 0
Day of procedure and days 1,2 and 3 post-procedure
Secondary outcome [2] 378590 0
Time off work in days
Timepoint [2] 378590 0
Up to day 30 post-procedure as reported by the participant at 30 day phone follow-up.
Secondary outcome [3] 378591 0
Patients not requiring opiates
Timepoint [3] 378591 0
Recorded at days 1,2 and 3 and 4 post-procedure by a self-completed diary.
Secondary outcome [4] 378592 0
Post-operative surgical complications graded by the Clavien-Dindo Classification of Surgical Complications up to day 30 post-procedure as reported by the participant at day 30 follow-up and/or from the medical record if admitted for any reason poast-procedure
Timepoint [4] 378592 0
Up to day 30 post-procedure as reported by the participant at day 30 follow-up and/or from the medical record if admitted for any reason post-procedure
Secondary outcome [5] 378593 0
Incidence of repeat procedure
Timepoint [5] 378593 0
Within 30 days of index procedure will be compared between groups based on medical record review.
Secondary outcome [6] 378594 0
Proportion of patients developing urinary retention requiring catheterization between groups as recorded in medical record or reported by the patient.
Timepoint [6] 378594 0
By day 30 post-procedure
Secondary outcome [7] 378595 0
Patient reported satisfaction with analgesia after discharge (Likert scale and percent satisfaction)
Timepoint [7] 378595 0
At day 5.
Secondary outcome [8] 378596 0
Proportion of participants that would recommend the procedure to friends or family if they required it
Timepoint [8] 378596 0
Assessed at day 30 post-procedure at phone follow-up.

Eligibility
Key inclusion criteria
Patients aged 18 years and over who present to the colorectal outpatient clinic or the private rooms of participating surgeons with symptomatic haemorrhoids suitable for banding will be considered for inclusion and offered study information.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A person will be excluded if they have the following:
• Coexisting anorectal disease such as anal fissure, fistula in ano, perianal abscess, thrombosed haemorrhoids, or colorectal malignancy
• A current medical history of uncontrolled ischemic heart disease, heart block, pregnancy or currently breastfeeding, severe hypertension (systolic blood pressure greater than 180mmHg), or orthostatic hypotension
• Poor general condition (i.e ASA classification 4 or 5)
• Allergy or sensitivity to diltiazem, lignocaine or polyethylene glycol (PEG) USP ointment base
• Current calcium channel blocker use
• Known side effects from previous calcium channel blocker use
• Refuse or are unable to give written informed consent to participate in the study.

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)
Central computer based randmisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
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
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/12/2020
Actual
3/03/2021
Date of last participant enrolment
Anticipated
15/12/2022
Actual
8/10/2021
Date of last data collection
Anticipated
31/01/2023
Actual
9/12/2021
Sample size
Target
100
Accrual to date
Final
99
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 15584 0
John Hunter Hospital - New Lambton
Recruitment hospital [2] 15585 0
Belmont Hospital - Belmont
Recruitment hospital [3] 15586 0
Newcastle Private Hospital - New Lambton Heights
Recruitment hospital [4] 15791 0
Newcastle Endoscopy Centre - Charlestown
Recruitment postcode(s) [1] 28982 0
2280 - Belmont
Recruitment postcode(s) [2] 28984 0
2290 - Charlestown
Recruitment postcode(s) [3] 28981 0
2305 - New Lambton
Recruitment postcode(s) [4] 28983 0
2305 - New Lambton Heights

Funding & Sponsors
Funding source category [1] 304646 0
Hospital
Name [1] 304646 0
John Hunter Hospital
Country [1] 304646 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Local Health District
Address
Lookout Road
New Lambton Heights
NSW 2305
Country
Australia
Secondary sponsor category [1] 304949 0
None
Name [1] 304949 0
Address [1] 304949 0
Country [1] 304949 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305067 0
Hunter New England human Research Ethics Committee
Ethics committee address [1] 305067 0
Locked bag 1
New Lambton
NSW 2305
Ethics committee country [1] 305067 0
Australia
Date submitted for ethics approval [1] 305067 0
31/01/2020
Approval date [1] 305067 0
20/04/2020
Ethics approval number [1] 305067 0

Summary
Brief summary
Haemorrhoidal symptoms are among the commonest complaints of mankind, it can occur in up to 80% of the population, involving any age and affecting both males and females equally. Surgical haemorrhoidectomy is most commonly used for 3rd or 4th degree haemorrhoids. However, surgery is associated with severe postoperative pain that is a source of such anxiety that some patients decide not to undergo the operation. Due to this, another non-surgical method can be used such as rubber band ligation, however this still requires pain relief. Research has suggested that current forms of pain relief are short term, caused more pain. Therefore, topical local anaesthetic agents are the next appealing option although have not been as successful as anticipated. Lignocaine in combination with Diltiazem are options that have not been used in this area and could potentially be more effective in relieving pain.
This trial will examine the role of diltiazem and lignocaine in reducing post-procedure pain.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99154 0
Prof Stephen Smith
Address 99154 0
Surgical Services
John Hunter Hospital
Locked Bag 1
Hunter Region Mail Centre
NSW 2310
Country 99154 0
Australia
Phone 99154 0
+61 2 4923 6397
Fax 99154 0
Email 99154 0
HNELHD-SurgeryResearch@health.nsw.gov.au
Contact person for public queries
Name 99155 0
Ms Rosemary Carroll
Address 99155 0
Surgical Services
John Hunter Hospital
Locked Bag 1
Hunter Region Mail Centre
NSW 2310
Country 99155 0
Australia
Phone 99155 0
+61 2 4923 6397
Fax 99155 0
Email 99155 0
HNELHD-SurgeryResearch@health.nsw.gov.au
Contact person for scientific queries
Name 99156 0
Prof Stephen Smith
Address 99156 0
Surgical Services
John Hunter Hospital
Locked Bag 1
Hunter Region Mail Centre
NSW 2310
Country 99156 0
Australia
Phone 99156 0
+61 2 4923 6397
Fax 99156 0
Email 99156 0
HNELHD-SurgeryResearch@health.nsw.gov.au

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


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
SourceTitleYear of PublicationDOI
EmbaseTopical Lidocaine or Lidocaine/Diltiazem Ointment Following Rubber Band Ligation of Hemorrhoids: A Prospective 3-Armed Randomized Controlled Trial.2023https://dx.doi.org/10.1097/DCR.0000000000002774
N.B. These documents automatically identified may not have been verified by the study sponsor.