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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03343509




Registration number
NCT03343509
Ethics application status
Date submitted
5/11/2017
Date registered
17/11/2017

Titles & IDs
Public title
Topical Versus Oral Metronidazole Following Excisional Haemorrhoidectomy
Scientific title
A Prospective, Multicentre, Double-Blinded Randomised Controlled Trial Comparing Topical Versus Oral Metronidazole in Reducing Post-Operative Pain Following Excisional Haemorrhoidectomy
Secondary ID [1] 0 0
MetHaemorrhoid
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hemorrhoids 0 0
Postoperative Pain 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Oral and Gastrointestinal 0 0 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
Treatment: Drugs - Metronidazole Oral
Treatment: Drugs - Metronidazole Ointment
Treatment: Drugs - Placebo Oral Tablet
Treatment: Drugs - Placebo Ointment

Experimental: Group A - Oral - Oral metronidazole 400mg 3 times a day for 7 days Placebo ointment applied 3 time times a day for 7 days to affected region

Experimental: Group B - Topical - Topical metronidazole ointment 10% 3 times a day for 7 days Oral placebo tablets 3 times a day for 7 days


Treatment: Drugs: Metronidazole Oral
Oral Metronidazole

Treatment: Drugs: Metronidazole Ointment
Metronidazole Ointment

Treatment: Drugs: Placebo Oral Tablet
Placebo Tablet

Treatment: Drugs: Placebo Ointment
Placebo Ointment
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Daily Post-Operative Pain
Timepoint [1] 0 0
Day 7
Secondary outcome [1] 0 0
Total Analgesia Use
Timepoint [1] 0 0
Day 7
Secondary outcome [2] 0 0
Complication Rates
Timepoint [2] 0 0
Day 30
Secondary outcome [3] 0 0
Return to Normal Activity
Timepoint [3] 0 0
Day 30 (Followed up until returned back to normal)
Secondary outcome [4] 0 0
Return of Bowel Function
Timepoint [4] 0 0
Day 7

Eligibility
Key inclusion criteria
* All patients undergoing excisional haemorrhoidectomy
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* < 16 years of age
* Have a simultaneous operation other than excisional haemorrhoidectomy
* History of chronic pain
* Previous allergy/adverse reaction to metronidazole
* Patients unable to consent or complete data questionnaires due to cognitive impairment

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
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 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/03/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2020
Sample size
Target
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
University of Auckland, New Zealand
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Andrew G Hill, MBChB
Address 0 0
The University of Auckland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not to be shared


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03343509