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Topical vs Oral Metronidazole After Benign Anorectal Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05038605
Recruitment Status : Completed
First Posted : September 9, 2021
Last Update Posted : September 9, 2021
Sponsor:
Information provided by (Responsible Party):
Sameh Emile, Mansoura University

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : January 24, 2020
Actual Primary Completion Date : January 30, 2021
Actual Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05038605


Locations
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Egypt
Mansoura university hospital
Mansourah, Dakahlia, Egypt, 35516
Sponsors and Collaborators
Mansoura University
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Responsible Party: Sameh Emile, Associate professor of surgery, Mansoura University
ClinicalTrials.gov Identifier: NCT05038605    
Other Study ID Numbers: Mansoura2021
First Posted: September 9, 2021    Key Record Dates
Last Update Posted: September 9, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemorrhoids
Rectal Fistula
Fissure in Ano
Fistula
Pathological Conditions, Anatomical
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Intestinal Fistula
Digestive System Fistula
Anus Diseases
Metronidazole
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents