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Completed

NCT Number: NCT05038605

Topical vs Oral Metronidazole After Benign Anorectal Surgery

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.

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Key information

Conditions

Hemorrhoids Anal Fissure Anal Fistula Anus Diseases Cardiovascular Diseases Digestive System Diseases Digestive System Fistula Fissure in Ano Fistula Gastrointestinal Diseases Intestinal Diseases Intestinal Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Rectal Diseases Rectal Fistula Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura university hospital

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Topical metronidazole

Drug

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

oral metronidazole

Drug

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

Primary outcomes

  1. Postoperative pain score

    Time frame: at one day after surgery

    Pain was assessed using visual analogue scale form 0 to 10, higher score indicates worse pain

  2. Postoperative pain score

    Time frame: at two days after surgery

    Pain was assessed using visual analogue scale form 0 to 10, higher score indicates worse pain

  3. Postoperative pain score

    Time frame: at seven days after surgery

    Pain was assessed using visual analogue scale form 0 to 10, higher score indicates worse pain

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Topical Versus Oral Metronidazole for Pain Relief After Surgery for Benign Anorectal Conditions; a Prospective Randomized Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 9, 2021
Registry last updated
Sep 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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