Topical vs Oral Metronidazole After Benign Anorectal Surgery

NCT ID: NCT05038605

Last Updated: 2021-09-09

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-24

Study Completion Date

2021-03-01

Brief Summary

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While some investigators found oral metronidazole to be effective in reducing pain after hemorrhoidectomy, other researchers did not find a significant analgesic effect of systemic metronidazole. On the other hand, topical application of metronidazole had more consistent favorable results as Ala et al documented a remarkable analgesic effect of topical metronidazole 10% after excisional hemorrhoidectomy which was in line with Nicholson and Armestrong who also concluded similar results.

No previous study compared the analgesic effect of topical and oral metronidazole after anorectal surgery. Therefore, the present trial was conducted to compare the impact of oral versus systemic metronidazole on pain and recovery after surgery for benign anorectal conditions.

Detailed Description

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Conditions

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Hemorrhoids Anal Fissure Anal Fistula

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Topical metronidazole

Topical application of metronidazole cream on the anal verge after surgery

Group Type ACTIVE_COMPARATOR

Topical metronidazole

Intervention Type DRUG

Topical application of metronidazole cream on the anal verge every 8 hours after surgery

Oral metronidazole

oral metronidazole 500 mg tablets after surgery

Group Type ACTIVE_COMPARATOR

oral metronidazole

Intervention Type DRUG

Patients received oral metronidazole 500 mg tablets every 8 hours after surgery

Control

No metronidazole was received

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Topical metronidazole

Topical application of metronidazole cream on the anal verge every 8 hours after surgery

Intervention Type DRUG

oral metronidazole

Patients received oral metronidazole 500 mg tablets every 8 hours after surgery

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult patients of either sex aged below 70 years
* Underwent surgery for hemorrhoids, anal fissure, or simple anal fistula.

Exclusion Criteria

* Grade I-II hemorrhoids.
* acute anal fissure.
* complex anal fistula
* perianal abscess
* perianal Crohn's disease
* malignancy.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Sameh Emile

Associate professor of surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mansoura university hospital

Al Mansurah, Dakahlia Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Mansoura2021

Identifier Type: -

Identifier Source: org_study_id

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