- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05038605
Topical vs Oral Metronidazole After Benign Anorectal Surgery
Topical Versus Oral Metronidazole for Pain Relief After Surgery for Benign Anorectal Conditions; a Prospective Randomized Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Dakahlia
-
Mansourah, Dakahlia, Egypt, 35516
- Mansoura University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Topical metronidazole
Topical application of metronidazole cream on the anal verge after surgery
|
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
|
Patients received oral metronidazole 500 mg tablets every 8 hours after surgery
|
No Intervention: Control
No metronidazole was received
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
at one day after surgery
|
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
|
at two days after surgery
|
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
|
at seven days after surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Gastrointestinal Diseases
- Intestinal Diseases
- Pathological Conditions, Anatomical
- Rectal Diseases
- Intestinal Fistula
- Digestive System Fistula
- Anus Diseases
- Fistula
- Rectal Fistula
- Hemorrhoids
- Fissure in Ano
- Anti-Infective Agents
- Anti-Bacterial Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Metronidazole
Other Study ID Numbers
- Mansoura2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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