Haemorrhoidectomy
Conditions
Brief summary
The purpose of this study is to determine whether metronidazole 10% ointment , applied topically three times a day in and around the anus, on the reduction of pain following haemorrhoidectomy.
Interventions
DRUGMetronidazole
10% ointment, three times daily for 14 days
Sponsors
S.L.A. Pharma AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have Grade 3 or 4 haemorrhoids (external disease with or without significant internal component) * Be scheduled for diathermy haemorroidectomy with ≥2 quadrant involvement * Be medically fit for surgery * Subjects must be aged 18 years or over and of the legal age of consent. * If female, the subject must not be lactating and must be (a) post-menopausal, (b) surgically sterilised, or (c) have a negative pregnancy test result prior to entry into the study and will use adequate contraception for the duration of the study. * Must have provided written informed consent to participate.
Exclusion criteria
* They have had surgery to the anus or rectum in the past 8 weeks * Suffer from a chronic pain syndrome which requires regular narcotic analgesia * Have anal fissures * Have diagnosed Crohn's disease * Allergic to metronidazole * Are taking any prohibited medication. * Deemed mentally incompetent * Considered by their physician unlikely to be able to comply with the protocol. * Taken part in an experimental drug study in the preceding three months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to evaluate the efficacy of 10% metronidazole ointment in reducing post-operative pain associated with haemorrhoidectomy as compared to placebo. | 14 days |
Secondary
| Measure | Time frame |
|---|---|
| evaluate and compare the expected pain following haemorrhoidectomy in the treatment and placebo groups. overall patient satisfaction with the operation. the number of analgesics required post-operatively the time taken to return to work and/or | 56 days |
Countries
United Kingdom
Outcome results
None listed