Topical vs Oral Metronidazole After Benign Anorectal Surgery

Hemorrhoids Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05038605
• Other study ID #: Mansoura2021
• Status: Completed
• Phase: N/A
• Start date: January 24, 2020
• Est. completion date: March 1, 2021

Study information

• Verified date: August 2021
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: March 1, 2021
• Est. primary completion date: January 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anal Fissure
• Anal Fistula
• Fissure in Ano
• Fistula
• Hemorrhoids
• Rectal Fistula

Intervention

Drug:
• Topical metronidazole
Topical application of metronidazole cream on the anal verge every 8 hours after surgery
• oral metronidazole
Patients received oral metronidazole 500 mg tablets every 8 hours after surgery

Locations

Country	Name	City	State
Egypt	Mansoura university hospital	Mansourah	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain score	Pain was assessed using visual analogue scale form 0 to 10, higher score indicates worse pain	at one day after surgery
Primary	Postoperative pain score	Pain was assessed using visual analogue scale form 0 to 10, higher score indicates worse pain	at two days after surgery
Primary	Postoperative pain score	Pain was assessed using visual analogue scale form 0 to 10, higher score indicates worse pain	at seven days after surgery