Topical Versus Oral Metronidazole Following Excisional Haemorrhoidectomy

NCT03343509 | Completed Phase 4 DMC

• 1 other identifier: MetHaemorrhoid
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Hemorrhoids; Postoperative Pain

Keywords

Hemorrhoidectomy; Metronidazole; Postoperative analgesia

Outcome Measures

Primary Outcomes (1)

• Daily Post-Operative Pain

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

  Day 7

Secondary Outcomes (4)

• Total Analgesia Use

  Day 7

• Complication Rates

  Day 30

• Return to Normal Activity

  Day 30 (Followed up until returned back to normal)

• Return of Bowel Function

  Day 7

Study Arms (2)

Group A - Oral

EXPERIMENTAL

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

Group B - Topical

EXPERIMENTAL

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

Metronidazole Oral DRUG

Oral Metronidazole

Group A - Oral

Metronidazole Ointment DRUG

Metronidazole Ointment

Group B - Topical

Placebo Oral Tablet DRUG

Placebo Tablet

Group B - Topical

Placebo Ointment DRUG

Placebo Ointment

Group A - Oral

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients undergoing excisional haemorrhoidectomy

You may not qualify if:

• \< 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

Sponsors & Collaborators

• University of Auckland, New Zealand: lead

Study Sites (2)

Manukau SuperClinic, Counties Manukau District Health Board

Auckland, New Zealand

Location

Ormiston Hospital

Auckland, New Zealand

Location

MeSH Terms

Conditions

Hemorrhoids; Pain, Postoperative

Interventions

Metronidazole

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Andrew G Hill, MBChB

  The University of Auckland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 5, 2017
• First Posted: November 17, 2017
• Study Start: March 11, 2019
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: November 3, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (2)