Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000689178
Ethics application status
Approved
Date submitted
5/05/2019
Date registered
8/05/2019
Date last updated
8/05/2019
Date data sharing statement initially provided
8/05/2019
Date results information initially provided
8/05/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomized Controlled Trial of the impact of pain relief checklists on pain outcomes in patients after a hemorrhoidectomy
Scientific title
Randomized Controlled Trial of the impact of post-hemorrhoidectomy pain relief checklists on pain outcomes
Secondary ID [1] 298118 0
Nil known
Universal Trial Number (UTN)
None
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
post-hemorrhoidectomy pain 312648 0
Condition category
Condition code
Surgery 311144 311144 0 0
Other surgery
Oral and Gastrointestinal 311225 311225 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
Brief Name of intervention: Post-hemorrhoidectomy pain relief checklist

Patients were recruited by the colorectal surgeon performing their hemorrhoidectomy who gave the patient an envelope that had been allocated to either the control group or intervention (checklist) group. The surgeon was blinded to the allocation of the envelope. If the patient received an envelope that allocated them to the checklist group, then they would receive a visual analogue scale form and a checklist of their post-operative pain medications contained within it. They were to record their levels of pain on the visual analogue scales at 3 specified times each day and fill out the checklist as they took their medications for 14 days after their hemorrhoidectomy. This was done in the patient's own home. Once complete, they were also provided with an envelope addressed to our collection centre to mail their forms to.

Intervention code [1] 314342 0
Behaviour
Comparator / control treatment
The control group was also recruited by the colorectal surgeon performing their hemorrhoidectomy who gave the patient an envelope, while blinded, that allocated them to the control group. Their envelope contained the same visual analogue scale form as the checklist/intervention group but without a checklist. They also received the same post-operative pain medications as the checklist group and were also asked to record their levels of pain on the visual analogue scales at 3 specified times each day as they took their medications for 14 days after their hemorrhoidectomy. This was done in the patient's own home. Once complete, they were also provided with an envelope addressed to our collection centre to mail their forms to.
Control group
Active

Outcomes
Primary outcome [1] 319931 0
Daily mean pain and overall mean pain across the 14 days post-operatively for each patient as assessed by visual analogue scale
Timepoint [1] 319931 0
Assessed daily for 14 days post-haemorrhoidectomy
Secondary outcome [1] 369922 0
Nil
Timepoint [1] 369922 0
Nil

Eligibility
Key inclusion criteria
participants undergoing an open hemorrhoidectomy for third or fourth degree hemorrhoids at Concord Repatriation General Hospital and Macquarie University Hospital in Sydney, Australia between August 2017 and November 2018
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant women, children under 18

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)
Sealed opaque numbered envelopes were used for allocation concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation was conducted using ‘Graphpad Random Group Allocator’ to randomly allocate 100 numbered envelopes evenly into either a control group or a checklist treatment group
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Prior to commencement of the study, a sample size calculation performed using PASS Power Analysis Software determined that 27 participants would be required on each arm of the experiment to show 1 SD difference between the two groups with a power level of 0.8, significance level (a) of 0.05 and size of worthwhile difference of 7 on the VAS.

Statistical analysis was conducted utilising a multiple regression model in SPSS software (IBM Corp. 2017) with the dependent variable being ‘mean pain’ and the independent variables being ‘day’ and ‘group’. Differences in mean pain between the two groups on each day as well as differences in overall mean pain for each group were calculated with 95% confidence intervals.



Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
21/08/2017
Date of last participant enrolment
Anticipated
Actual
25/06/2018
Date of last data collection
Anticipated
Actual
6/11/2018
Sample size
Target
54
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 13681 0
Concord Repatriation Hospital - Concord
Recruitment hospital [2] 13682 0
Macquarie University Hospital - Macquarie Park
Recruitment postcode(s) [1] 26365 0
2139 - Concord
Recruitment postcode(s) [2] 26366 0
2109 - Macquarie Park

Funding & Sponsors
Funding source category [1] 302651 0
Hospital
Name [1] 302651 0
Concord Repatriation General Hospital
Country [1] 302651 0
Australia
Funding source category [2] 302701 0
Hospital
Name [2] 302701 0
Macquarie University Hospital
Country [2] 302701 0
Australia
Primary sponsor type
Individual
Name
Matthew Rickard
Address
Concord Repatriation General Hospital
Medical Centre, Level 1, Suite 102 Hospital Road, Concord NSW 2139
Country
Australia
Secondary sponsor category [1] 302568 0
Individual
Name [1] 302568 0
Johnny Huang
Address [1] 302568 0
Concord Repatriation General Hospital
Medical Centre, Level 1, Suite 102 Hospital Road, Concord NSW 2139
Country [1] 302568 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303275 0
Sydney Local Health District Human Research Ethics Committee-Concord Repatriation General Hospital
Ethics committee address [1] 303275 0
Concord Repatriation General Hospital
Building 20, Hospital Road
Concord, NSW, 2139
Ethics committee country [1] 303275 0
Australia
Date submitted for ethics approval [1] 303275 0
13/03/2017
Approval date [1] 303275 0
21/04/2017
Ethics approval number [1] 303275 0
HREC/17/CRGH/19
Ethics committee name [2] 303281 0
Macquarie University Human Research Ethics Committee
Ethics committee address [2] 303281 0
Suite 407, Level 4, F10A Building
2 Technology Place
Macquarie University, NSW 2109, Australia
Ethics committee country [2] 303281 0
Australia
Date submitted for ethics approval [2] 303281 0
14/06/2017
Approval date [2] 303281 0
07/08/2017
Ethics approval number [2] 303281 0
MQCRG2017003

Summary
Brief summary
A major concern regarding hemorrhoidectomy is the considerable post­-operative pain experienced by patients for up to 14 days after surgery. Current pain management after a hemorrhoidectomy involves a 2 week extensive course of analgesics. However, a lack of adherence to such an extensive treatment plan may result in suboptimal pain relief. This randomised controlled trial aims to determine if patients who receive a checklist of their prescribed medications which they must tick off each day (checklist group) experience better pain relief than patients who receive the same medications without a checklist (control group). We hypothesised that participants in the checklist group would experience better pain relief compared to the control group due to the checklist helping them keep track of what time and dose they need to take their medication as well as what they have already taken. We intend for the results of the trial to be used as a starting point for the implementation of effective non-pharmacological adjuncts to pharmacological pain management after hemorrhoidectomies.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93098 0
A/Prof Matthew Rickard
Address 93098 0
Concord Repatriation General Hospital
Medical Centre, Level 1, Suite 102 Hospital Road, Concord NSW 2139
Country 93098 0
Australia
Phone 93098 0
+61 02 9767 7950
Fax 93098 0
+61 02 9767 6555
Email 93098 0
[email protected]
Contact person for public queries
Name 93099 0
Mr Johnny Huang
Address 93099 0
Concord Repatriation General Hospital
Medical Centre, Level 1, Suite 102 Hospital Road, Concord NSW 2139
Country 93099 0
Australia
Phone 93099 0
+61425666830
Fax 93099 0
Email 93099 0
[email protected]
Contact person for scientific queries
Name 93100 0
Mr Johnny Huang
Address 93100 0
Concord Repatriation General Hospital
Medical Centre, Level 1, Suite 102 Hospital Road, Concord NSW 2139
Country 93100 0
Australia
Phone 93100 0
+61425666830
Fax 93100 0
Email 93100 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
To maintain patient confidentiality.


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.