Topical vs Oral Metronidazole After Benign Anorectal Surgery

• Sponsor: Mansoura University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05038605
• Collaborator: (none)
• Enrollment: 108
• Location: 1
• Arms: 3
• Actual Duration (Months): 13.2
• Patients Per Site Per Month: 8.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hemorrhoids; Anal Fissure; Anal Fistula	Drug: Topical metronidazole; Drug: oral metronidazole	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 108 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Topical Versus Oral Metronidazole for Pain Relief After Surgery for Benign Anorectal Conditions; a Prospective Randomized Study
• Actual Study Start Date: Jan 24, 2020
• Actual Primary Completion Date: Jan 30, 2021
• Actual Study Completion Date: Mar 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Topical metronidazole Topical application of metronidazole cream on the anal verge after surgery	Drug: Topical metronidazole; Topical application of metronidazole cream on the anal verge every 8 hours after surgery
Active Comparator: Oral metronidazole oral metronidazole 500 mg tablets after surgery	Drug: oral metronidazole; Patients received oral metronidazole 500 mg tablets every 8 hours after surgery
No Intervention: Control No metronidazole was received

Outcome Measures

Primary Outcome Measures

1. Postoperative pain score [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 [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 [at seven days after surgery]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mansoura university hospital	Mansourah	Dakahlia	Egypt	35516

Sponsors and Collaborators

• Mansoura University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sameh Emile, Associate professor of surgery, Mansoura University
• ClinicalTrials.gov Identifier: NCT05038605
• Other Study ID Numbers: Mansoura2021
• First Posted: Sep 9, 2021
• Last Update Posted: Sep 9, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hemorrhoids; Rectal Fistula; Fissure in Ano; Fistula; Metronidazole

Study Results

No Results Posted as of Sep 9, 2021