Topical vs Oral Metronidazole After Benign Anorectal Surgery

Not Applicable

Completed

• Conditions: Anal Fissure; Anal Fistula; Hemorrhoids
• Interventions: Drug: oral metronidazole; Drug: Topical metronidazole

• Registration Number: NCT05038605
• Lead Sponsor: Mansoura University

Brief Summary

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-01-24
• Primary Completion: 2021-01-30
• Study Completion: 2021-03-01
• Status Verified: 2021-08
• Study First Submitted: 2021-08-29
• Study First Submitted QC: 2021-08-31
• Last Update Submitted: 2021-08-31
• Study First Posted: 2021-09-09
• Last Update Posted: 2021-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

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

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Exclusion Criteria

• Grade I-II hemorrhoids.
• acute anal fissure.
• complex anal fistula
• perianal abscess
• perianal Crohn's disease
• malignancy.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral metronidazole	oral metronidazole	oral metronidazole 500 mg tablets after surgery
Topical metronidazole	Topical metronidazole	Topical application of metronidazole cream on the anal verge after surgery

Primary Outcome Measures

Name	Time	Method
Postoperative pain score	at seven days after surgery	Pain was assessed using visual analogue scale form 0 to 10, higher score indicates worse pain

Trial Locations

Locations (1)

Mansoura university hospital; 🇪🇬 Mansourah, Dakahlia, Egypt