Topical Versus Oral Metronidazole Following Excisional Haemorrhoidectomy

Postoperative Pain Clinical Trial

Official title:

A Prospective, Multicentre, Double-Blinded Randomised Controlled Trial Comparing Topical Versus Oral Metronidazole in Reducing Post-Operative Pain Following Excisional Haemorrhoidectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03343509
• Other study ID #: MetHaemorrhoid
• Status: Completed
• Phase: Phase 4
• Start date: March 11, 2019
• Est. completion date: February 1, 2020

Study information

• Verified date: November 2020
• Source: University of Auckland, New Zealand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• All patients undergoing excisional haemorrhoidectomy

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

Related Conditions & MeSH terms

• Hemorrhoids
• Postoperative Pain

Intervention

Drug:
• Metronidazole Oral
Oral Metronidazole
• Metronidazole Ointment
Metronidazole Ointment
• Placebo Oral Tablet
Placebo Tablet
• Placebo Ointment
Placebo Ointment

Locations

Country	Name	City	State
New Zealand	Manukau SuperClinic, Counties Manukau District Health Board	Auckland
New Zealand	Ormiston Hospital	Auckland

Sponsors (1)

Lead Sponsor	Collaborator
University of Auckland, New Zealand

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily Post-Operative Pain	Daily Post-Operative Pain Measured on Visual Analogue Scale (0 to 10)	Day 7
Secondary	Total Analgesia Use	Measured in Morphine Equivalent Doses	Day 7
Secondary	Complication Rates	Short term complication rates including adverse reactions, bleeding, paraesthesiae, urinary retention, readmission	Day 30
Secondary	Return to Normal Activity	Time to return back to normal activity	Day 30 (Followed up until returned back to normal)
Secondary	Return of Bowel Function	Time for first bowel motion	Day 7