Topical Versus Oral Metronidazole Following Excisional Haemorrhoidectomy
- Conditions
- HemorrhoidsPostoperative Pain
- Interventions
- Registration Number
- NCT03343509
- Lead Sponsor
- University of Auckland, New Zealand
- 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.
- Detailed Description
The pathogenesis of post-operative excisional haemorrhoidectomy pain is multi-factorial with secondary bacterial colonisation, inflammation and anal sphincter spasm/hypertonicity all purposed to play a role. Several pharmacological agents have been introduced in the last two decades targeting specific parts of the hypothesized pathway of pain pathogenesis showing promising improvements.
Metronidazole is part of the nitroimidazole class of antibiotics and primarily affects anaerobic bacteria and protozoa and traditionally has been used in surgical prophylaxis and treating anaerobic infections. It has been postulated to decrease pain following EH via two mechanisms; first by decreasing secondary bacterial colonisation and hence reducing post-operative inflammation; and second via a hitherto poorly understood direct anti-inflammatory response. The oral route has been initially investigated but topical administration has more recently been mooted for analgesia and theoretically reduces the unpleasant systemic side effects of oral administration. Our research group has recently completed a systematic review of both oral and topical administration of metronidazole. This review showed benefit in reducing postoperative haemorrhoidectomy pain from both routes of administration but this far there has been no comparison of the two routes.
Metronidazole has been proposed to have both anti-bacterial and pleiotropic anti-inflammatory properties but its precise mechanism of action is unknown. The increased understanding of this novel use of an agent with a known pharmacological profile will generally broaden our use of a simple, cheap and widespread agent. The investigators hope research into this drug will enable its use beyond that of haemorrhoidectomies, with possible pleiotropic applications into other similar operations.
Given the high prevalence of haemorrhoids in a vital segment of New Zealand's population, this research will contribute to improved outcomes for affected patients. Decreasing the significant post-operative pain will improve the quality of life for New Zealanders as well as affected populations worldwide. Socially and financially, it will enable earlier return to normal activity and reduce the burden on visits and readmissions to primary and secondary care, respectively.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- All patients undergoing excisional haemorrhoidectomy
- < 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A - Oral Metronidazole 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 Group B - Topical Placebo Oral Tablet Topical metronidazole ointment 10% 3 times a day for 7 days Oral placebo tablets 3 times a day for 7 days Group A - Oral Placebo Ointment Oral metronidazole 400mg 3 times a day for 7 days Placebo ointment applied 3 time times a day for 7 days to affected region Group B - Topical Metronidazole Ointment Topical metronidazole ointment 10% 3 times a day for 7 days Oral placebo tablets 3 times a day for 7 days
- Primary Outcome Measures
Name Time Method Daily Post-Operative Pain Day 7 Daily Post-Operative Pain Measured on Visual Analogue Scale (0 to 10)
- Secondary Outcome Measures
Name Time Method Total Analgesia Use Day 7 Measured in Morphine Equivalent Doses
Complication Rates Day 30 Short term complication rates including adverse reactions, bleeding, paraesthesiae, urinary retention, readmission
Return to Normal Activity Day 30 (Followed up until returned back to normal) Time to return back to normal activity
Return of Bowel Function Day 7 Time for first bowel motion
Trial Locations
- Locations (2)
Ormiston Hospital
🇳🇿Auckland, New Zealand
Manukau SuperClinic, Counties Manukau District Health Board
🇳🇿Auckland, New Zealand