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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2008-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Topical Versus Oral Metronidazole Following Excisional Haemorrhoidectomy

NCT03343509

Hemorrhoids Postoperative Pain

COMPLETED PHASE4

Topical Analgesia Post-Haemorrhoidectomy

NCT04276298

Hemorrhoid Pain Hemorrhoids

COMPLETED PHASE2/PHASE3

Effectiveness of Metronidazole in Pain Control Posthemorrhoidectomy

NCT02328144

Hemorrhoids

COMPLETED PHASE3

Topical vs Oral Metronidazole After Benign Anorectal Surgery

NCT05038605

Hemorrhoids Anal Fissure Anal Fistula

COMPLETED NA

Evaluation of the Effectiveness of a Topical Medical Device in Wound Healing and Symptom Relief in the Postoperative Period of Open Excisional Hemorrhoidectomy (The Emor Study)

NCT06872151

Anus Diseases Gastrointestinal Diseases Intestinal Diseases +3 more

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Haemorrhoidectomy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Metronidazole

Group Type EXPERIMENTAL

Metronidazole

Intervention Type DRUG

10% ointment, three times daily for 14 days

Placebo

Group Type PLACEBO_COMPARATOR

Metronidazole

Intervention Type DRUG

10% ointment, three times daily for 14 days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Metronidazole

10% ointment, three times daily for 14 days

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No