A Randomised Controlled Trial of the Use of Topical Metronidazole (10%) to Reduce Pain After Haemorrhoidectomy

Phase 2

Completed

• Conditions: Haemorrhoidectomy
• Interventions: Drug: Metronidazole

• Registration Number: NCT00774722
• Lead Sponsor: S.L.A. Pharma AG

Brief Summary

The purpose of this study is to determine whether metronidazole 10% ointment , applied topically three times a day in and around the anus, on the reduction of pain following haemorrhoidectomy.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Study First Submitted: 2008-10-16
• Study First Submitted QC: 2008-10-16
• Study First Posted: 2008-10-17
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-04
• Last Update Posted: 2013-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

• Have Grade 3 or 4 haemorrhoids (external disease with or without significant internal component)
• Be scheduled for diathermy haemorroidectomy with ≥2 quadrant involvement
• Be medically fit for surgery
• Subjects must be aged 18 years or over and of the legal age of consent.
• If female, the subject must not be lactating and must be (a) post-menopausal, (b) surgically sterilised, or (c) have a negative pregnancy test result prior to entry into the study and will use adequate contraception for the duration of the study.
• Must have provided written informed consent to participate.

Exclusion Criteria

• They have had surgery to the anus or rectum in the past 8 weeks
• Suffer from a chronic pain syndrome which requires regular narcotic analgesia
• Have anal fissures
• Have diagnosed Crohn's disease
• Allergic to metronidazole
• Are taking any prohibited medication.
• Deemed mentally incompetent
• Considered by their physician unlikely to be able to comply with the protocol.
• Taken part in an experimental drug study in the preceding three months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metronidazole	Metronidazole	-
Placebo	Metronidazole	-

Primary Outcome Measures

Name	Time	Method
The primary objective is to evaluate the efficacy of 10% metronidazole ointment in reducing post-operative pain associated with haemorrhoidectomy as compared to placebo.	14 days

Secondary Outcome Measures

Name	Time	Method
evaluate and compare the expected pain following haemorrhoidectomy in the treatment and placebo groups. overall patient satisfaction with the operation. the number of analgesics required post-operatively the time taken to return to work and/or	56 days

Trial Locations

Locations (5)

St Marks Hospital; 🇬🇧 Harrow, United Kingdom

Stepping Hill Hospital; 🇬🇧 Stockport, United Kingdom

St Thomas' Hospital, Lambeth Palace Road; 🇬🇧 London, United Kingdom

Royal Sussex County Hospital, Eastern Road,; 🇬🇧 Brighton, United Kingdom

North Middlesex University Hospital; 🇬🇧 London, United Kingdom