None listed
Conditions
Brief summary
We are planning on performing a double-blinded randomised controlled trial (RCT), investigating the role of oral metronidazole in the management of Post Open Haemorrhoidectomy pain. Haemorrhoidal disease is a common benign condition, with conventional open haemorrhoidectomy remaining the gold standard for treatment. The main post-operative complaint is pain. Various methods have been used to optimise analgesia post-haemorrhoidectomy. The most widely used pharmacological agent is metronidazole, typically administered orally. However, the overall quality of previous studies investigating this have been few in number and generally of poor quality. It is common practice however, for the majority of surgeons both nationally and internationally to administer a prophylactic course of oral metronidazole to decrease post haemorrhoidectomy pain. We hope to run our own RCT, double blinded, to assess whether oral metronidazole really does decrease post-operative pain. Patient will be either randomised to a seven day course of oral metronidazole (400mg TDS) or placebo. Patients will be followed up for 6 weeks, with the use of a 10-point Visual Analogue Scale (VAS) to assess their pain at various time intervals post-operatively.
Interventions
Intervention group: will take one 400mg metronidazole tablet, three times per day for 7 days after the patient has had their haemorrhoidectomy. This will commence in the evening (if the procedure was performed in the morning) or the following morning (if the procedure was performed in the afternoon).
Adherence to the intervention will be assessed by bottle returns.
Sponsors
Dr Grahame Ctercteko
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
o Age greater than or equal to 18 years old o Patient with grade III/IV internal haemorrhoids and/or external haemorrhoids, presenting for elective excisional open haemorrhoidectomy o Patient capable of participating in informed consent for the study o Patient willing to complete follow-up over the study period (6 weeks)
Exclusion criteria
o Patient unable or not willing to consent to procedure o Patient allergy to metronidazole o Patients who are immune suppressed o If patient receives any antibiotics during the 6-week trial period o Chronic kidney disease
Outcome results
None listed