Topical vs Oral Metronidazole After Benign Anorectal Surgery

M

Mansoura University

Status

Completed

Conditions

Anal Fissure
Anal Fistula
Hemorrhoids

Treatments

Drug: Topical metronidazole
Drug: oral metronidazole

Study type

Interventional

Funder types

Other

Identifiers

NCT05038605
Mansoura2021

Details and patient eligibility

About

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.

Enrollment

108 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

108 participants in 3 patient groups

Topical metronidazole
Active Comparator group
Description:
Topical application of metronidazole cream on the anal verge after surgery
Treatment:
Drug: Topical metronidazole
Oral metronidazole
Active Comparator group
Description:
oral metronidazole 500 mg tablets after surgery
Treatment:
Drug: oral metronidazole
Control
No Intervention group
Description:
No metronidazole was received

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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