Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000455965
Ethics application status
Approved
Date submitted
1/05/2011
Date registered
4/05/2011
Date last updated
4/05/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does Glyceryl Trinitrate (Rectogesic) reduce post Operative pain in Stapled Haemorrhoidectomy?: A Randomized Controlled Trial
Scientific title
Does Rectogesic reduce post Operative pain in Stapled Haemorrhoidectomy?: A Randomized Controlled Trial comparing Rectogesic to Conventional post operative Analgesia
Secondary ID [1] 253168 0
None
Universal Trial Number (UTN)
None
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Haemorrhoids and the effect of Rectogesic on post operative pain 258710 0
Condition category
Condition code
Surgery 258867 258867 0 0
Surgical techniques
Anaesthesiology 265923 265923 0 0
Pain management
Oral and Gastrointestinal 265924 265924 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
Patients will undertake the Stapled Haemorrhoidectomy operation and will then be randomized to either have Rectogesic or not post operatively.
Those that receive Glyceryl trinitrate will receive 0.2% Formulation applied three times a day topically to the anal canal with an applicator. The treatment is for 2 weeke post operatively and commences day 1 post op.
Intervention code [1] 257665 0
Treatment: Drugs
Comparator / control treatment
The control (non Rectogesic) group will recieve standard post operative care which is defined as Paracetamol 1g four times a day orally and Tramadol 50mg three times a day orally for 2 weeks
Control group
Active

Outcomes
Primary outcome [1] 266579 0
To determine if Rectogesic glyceryl trinitrate is beneficial post stapled haemorrhoidectomy

The patients were interviewed within 48 hrs by a clinical nurse to assess that they have recovered satisfactorily and that they were compliant in postoperative care including medications prescribed. Patients completed visual analogue scores on maximum pain, average pain and satisfaction, administered by an independent observer blinded to the randomization. Those with persistent problems were reviewed at 2 monthly intervals until they were symptom free. All patients agreed to a telephone interview conducted again at the closure of the study and clinical review was invited as required.
Data was analysed on an intention-to-treat basis. It was estimated that 100 patients in each arm would provide a 0.8 power to detect a 10% difference in pain scoring. Patients who failed to complete the program were treated as missing. Numerical data are presented as mean and range, or median and interquartile range (IQR), depending on the distribution. Comparisons between characteristics were calculated using 2 tests and 2 tests for trend, the nonparametric Wilcoxon tests, and t tests. Statistical analyses were conducted using SPSS for Windows version 18 (SPSS Inc, Chicago, IL). A significance level of 0.05 was adopted a priori.
Timepoint [1] 266579 0
1 month review post operatively
Secondary outcome [1] 276059 0
Bowel function, continence, persistent/recurrent haemorrhoidal symptoms and medication side effects were also assessed by questionnaire at the time of review.
Timepoint [1] 276059 0
1 month post operatively

Eligibility
Key inclusion criteria
Patients must have symptomatic haemmorhoids and be informed and be willing to participate in the trial.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Presence of skin tags requiring mucoscectomy.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/10/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264989 0
University
Name [1] 264989 0
James Cook University
Country [1] 264989 0
Australia
Funding source category [2] 264991 0
Hospital
Name [2] 264991 0
The Townsville Hospital
Country [2] 264991 0
Australia
Funding source category [3] 264992 0
Government body
Name [3] 264992 0
Queensland Health
Country [3] 264992 0
Australia
Primary sponsor type
Individual
Name
Trent Cross
Address
James Cook University
School of Medicine and Public Health
James Cook University
Douglas 4817
Townsville
Queensland
Country
Australia
Secondary sponsor category [1] 264075 0
Individual
Name [1] 264075 0
Professor Yik-Hong Ho
Address [1] 264075 0
Professor of Surgery and Head of Surgery
James Cook University School of Medicine
Clinical school
The Townsville Hospital
100 Angus Smith Drive
Douglas 4817
Townsville
Queensland
Country [1] 264075 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266945 0
Ethics Committee The Mater Miscordiae Hospital
Ethics committee address [1] 266945 0
Ethics committee country [1] 266945 0
Australia
Date submitted for ethics approval [1] 266945 0
21/05/2010
Approval date [1] 266945 0
12/06/2010
Ethics approval number [1] 266945 0

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

Contacts
Principal investigator
Name 31953 0
Address 31953 0
Country 31953 0
Phone 31953 0
Fax 31953 0
Email 31953 0
Contact person for public queries
Name 15200 0
Trent Cross
Address 15200 0
C/O
James Cook University
School of Medicine Clinical School
The Townsville Hospital
100 Angus Smith Drive
Douglas 4817
Townsville
Queensland
Country 15200 0
Australia
Phone 15200 0
+61 7 47 961111
Fax 15200 0
Email 15200 0
[email protected]
Contact person for scientific queries
Name 6128 0
Professor Yik Hong Ho
Address 6128 0
C/O
James Cook University
School of Medicine Clinical School
The Townsville Hospital
100 Angus Smith Drive
Douglas 4817
Townsville
Queensland
Country 6128 0
Australia
Phone 6128 0
+61 7 47 96 1111
Fax 6128 0
Email 6128 0
[email protected]

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.