Topical vs Oral Metronidazole After Benign Anorectal Surgery

NCT05038605 | Completed

• 1 other identifier: Mansoura2021
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemorrhoids; Anal Fissure; Anal Fistula

Outcome Measures

Primary Outcomes (3)

• Postoperative pain score

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

  at one day after surgery

• Postoperative pain score

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

  at two days after surgery

• Postoperative pain score

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

  at seven days after surgery

Study Arms (3)

Topical metronidazole

ACTIVE COMPARATOR

Topical application of metronidazole cream on the anal verge after surgery

Drug: Topical metronidazole

Oral metronidazole

ACTIVE COMPARATOR

oral metronidazole 500 mg tablets after surgery

Drug: oral metronidazole

Control

NO INTERVENTION

No metronidazole was received

Interventions

Topical metronidazole DRUG

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

Topical metronidazole

oral metronidazole DRUG

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

Oral metronidazole

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients of either sex aged below 70 years
• Underwent surgery for hemorrhoids, anal fissure, or simple anal fistula.

You may not qualify if:

• Grade I-II hemorrhoids.
• acute anal fissure.
• complex anal fistula
• perianal abscess
• perianal Crohn's disease
• malignancy.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura university hospital

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

MeSH Terms

Conditions

Hemorrhoids; Fissure in Ano; Rectal Fistula

Interventions

Metronidazole

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases; Anus Diseases; Intestinal Fistula; Digestive System Fistula; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of surgery

Study Record Dates

• First Submitted: August 29, 2021
• First Posted: September 9, 2021
• Study Start: January 24, 2020
• Primary Completion: January 30, 2021
• Study Completion: March 1, 2021
• Last Updated: September 9, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)