Topical Versus Oral Metronidazole Following Excisional Haemorrhoidectomy

NCT ID: NCT03343509

Last Updated: 2020-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-11
• Study Completion Date: 2020-02-01

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.

Conditions

Hemorrhoids; Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

Metronidazole Oral

Intervention Type: DRUG

Oral Metronidazole

Placebo Ointment

Intervention Type: DRUG

Placebo Ointment

Group B - Topical

Topical metronidazole ointment 10% 3 times a day for 7 days Oral placebo tablets 3 times a day for 7 days

Group Type: EXPERIMENTAL

Metronidazole Ointment

Intervention Type: DRUG

Metronidazole Ointment

Placebo Oral Tablet

Intervention Type: DRUG

Placebo Tablet

Interventions

Metronidazole Oral

Oral Metronidazole

Intervention Type: DRUG

Metronidazole Ointment

Metronidazole Ointment

Intervention Type: DRUG

Placebo Oral Tablet

Placebo Tablet

Intervention Type: DRUG

Placebo Ointment

Placebo Ointment

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Auckland, New Zealand

OTHER

Sponsor Role: lead

Responsible Party

Andrew G Hill, MBChB, MD (Thesis), EdD, FACS, FRACS

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrew G Hill, MBChB

Role: PRINCIPAL_INVESTIGATOR

The University of Auckland

Locations

Manukau SuperClinic, Counties Manukau District Health Board

Auckland, , New Zealand

Ormiston Hospital

Auckland, , New Zealand

Countries

New Zealand

Other Identifiers

MetHaemorrhoid

Identifier Type: -

Identifier Source: org_study_id