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Topical vs Oral Metronidazole After Benign Anorectal Surgery

Primary Purpose

Hemorrhoids, Anal Fissure, Anal Fistula

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Topical metronidazole

oral metronidazole

About this trial

This is an interventional treatment trial for Hemorrhoids

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Mansoura university hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

Arm Label

Topical metronidazole

Oral metronidazole

Control

Arm Description

Topical application of metronidazole cream on the anal verge after surgery

oral metronidazole 500 mg tablets after surgery

No metronidazole was received

Outcomes

Primary Outcome Measures

Postoperative pain score

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

Postoperative pain score

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

Postoperative pain score

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05038605

First Posted

August 29, 2021

Last Updated

August 31, 2021

Sponsor

Mansoura University

1. Study Identification

Unique Protocol Identification Number

NCT05038605

Brief Title

Topical vs Oral Metronidazole After Benign Anorectal Surgery

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

January 24, 2020 (Actual)

Primary Completion Date

January 30, 2021 (Actual)

Study Completion Date

March 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemorrhoids, Anal Fissure, Anal Fistula

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

108 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Topical metronidazole

Arm Type

Active Comparator

Arm Description

Topical application of metronidazole cream on the anal verge after surgery

Arm Title

Oral metronidazole

Arm Type

Active Comparator

Arm Description

oral metronidazole 500 mg tablets after surgery

Arm Title

Control

Arm Type

No Intervention

Arm Description

No metronidazole was received

Intervention Type

Drug

Intervention Name(s)

Topical metronidazole

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

oral metronidazole

Intervention Description

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

Primary Outcome Measure Information:

Title

Postoperative pain score

Description

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

Time Frame

at one day after surgery

Title

Postoperative pain score

Description

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

Time Frame

at two days after surgery

Title

Postoperative pain score

Description

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

Time Frame

at seven days after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

Mansoura university hospital

City

Mansourah

State/Province

Dakahlia

ZIP/Postal Code

35516

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Topical vs Oral Metronidazole After Benign Anorectal Surgery

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