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CompletedNCT03343509Updated Nov 3, 2020

Topical Versus Oral Metronidazole Following Excisional Haemorrhoidectomy

A Phase 4 interventional study of Metronidazole Oral and Metronidazole Ointment in Hemorrhoids and Postoperative Pain, sponsored by University of Auckland, New Zealand. Completed at 2 sites in New Zealand. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2020-11-03.

Sponsored by University of Auckland, New Zealand · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
16 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hemorrhoids
  • Postoperative Pain

Keywords

  • Hemorrhoidectomy
  • Metronidazole
  • Postoperative analgesia
03

In context

Hemorrhoids

238 studies on the registry are indexed under Hemorrhoids; 73 are open to participants now.

This study's enrollment of 120 is above the median of 100 across 183 interventional studies indexed under Hemorrhoids.

Browse Hemorrhoids studies →

Lead sponsor

University of Auckland, New Zealand is the lead sponsor of 57 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All patients undergoing excisional haemorrhoidectomy

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    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

    Drug: Metronidazole Oral · Drug: Placebo Ointment

  • Experimental
    Group B - Topical

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

    Drug: Metronidazole Ointment · Drug: Placebo Oral Tablet

Interventions

06

What researchers measure

Primary outcomes

  1. Daily Post-Operative Pain

    Daily Post-Operative Pain Measured on Visual Analogue Scale (0 to 10)

    Time frame: Day 7

Secondary outcomes

  1. Total Analgesia Use

    Measured in Morphine Equivalent Doses

    Time frame: Day 7

  2. Complication Rates

    Short term complication rates including adverse reactions, bleeding, paraesthesiae, urinary retention, readmission

    Time frame: Day 30

  3. Return to Normal Activity

    Time to return back to normal activity

    Time frame: Day 30 (Followed up until returned back to normal)

  4. Return of Bowel Function

    Time for first bowel motion

    Time frame: Day 7

07

Study locations

2 sites
  • Manukau SuperClinic, Counties Manukau District Health Board
    Auckland, New Zealand
  • Ormiston Hospital
    Auckland, New Zealand
08

References and documents

Individual participant data

Plan to share: No — Not to be shared

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 3, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03343509
Lead sponsor
University of Auckland, New Zealand
Responsible party
Andrew G Hill, MBChB, MD (Thesis), EdD, FACS, FRACS (Professor, University of Auckland, New Zealand) — Principal investigator
First posted
Nov 17, 2017
Start date
Mar 11, 2019
Primary completion
Feb 1, 2020
Completion
Feb 1, 2020
Last update
Nov 3, 2020

Study contacts

Andrew G Hill, MBChB
principal investigator · The University of Auckland

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Metronidazole

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