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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03343509




Registration number
NCT03343509
Ethics application status
Date submitted
5/11/2017
Date registered
17/11/2017
Date last updated
3/11/2020

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
This study aims to determine if topical metronidazole reduces pain more than oral
metronidazole following excisional haemorrhoidectomy. The trial will be a multi-centered,
patient and investigator blinded superiority trial with two parallel groups and a primary
outcome of pain scores during 14 days after surgery.

Group A will receive oral metronidazole and placebo cream. Group B will receive placebo
tablets and topical metronidazole cream.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03343509
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03343509