Download Study

General

Study Overview

Title:

Comparative Efficacy of Topical Metronidazole and Glyceryl Trinitrate versus Topical Glyceryl Trinitrate Alone in the Treatment of Acute Anal Fissure: A Randomized Clinical Trial

Study is 3ie funded:

No

Study ID:

RIDIE-STUDY-ID-6375ee39be092

Initial Registration Date:

11/17/2022

Last Update Date:

11/14/2022

Study Status:

Completed

Location(s):

Pakistan

Abstract:

This research aimed to determine if topical metronidazole treatment when combined with glyceryl trinitrate 0.2% (GTN), is more successful than GTN alone in reducing the time for an acute anal fissure to heal. This study was a single-blinded, randomized controlled trial conducted at the DHQ Hospital Okara from January 2022 to August 2022. Patients of both genders, aged 18 to 70 years, with acute anal fissures and without any exclusion criteria, were included. 140 patients who satisfied the inclusion criteria were randomized through the lottery technique and were divided into two groups (70 in each group). Three patients lost the follow-up. Out of the remaining 137, 70 (51.1%) patients were male. The patient’s ages ranged from 22 to 68 years, with a mean age of 39.18 ± 11.52. On week three follow-up, in group A out of 69 patients, 47 (68.1%) had complete healing, and 22 (31.8%) had partial healing, while in group B out of 68 patients, 16 (23.5%) had complete healing, 49 (72%) had partial healing (p = < 0.001, significant). Using topical metronidazole as an addition to standard therapy may reduce the chronicity of acute anal fissures and prevent surgical treatments with high rates of complications.

Registration Citation:

Categories:

Health, Nutrition, and Population

Additional Keywords:

glyceryl trinitrate, acute anal fissure, anal fissure, metronidazole, colorectal disease, pr bleeding

Secondary ID Number(s):

Principal Investigator(s)

Name of First PI:

Muhammad Hasaan Shahid

Affiliation:

Postgraduate Medical Institute, Lahore, Pakistan

Name of Second PI:

Sidra Javed

Affiliation:

DHQ Hospital Okara, Pakistan

Study Sponsor

Name:

It is a non funded study

Study Sponsor Location:

Pakistan

Research Partner

Name of Partner Institution:

No other partner present

Type of Organization:

Other

Location:

Pakistan

Intervention

Intervention Overview

Intervention:

In case of patients with anal fissure, metronidazole gel was used along with conventional Glyceryl trinitrate cream

Private Intervention Details:

Healing duration of anal fissure and pain relief was evaluated

Theory of Change:

Using topical metronidazole as an addition to standard therapy may reduce the chronicity of acute anal fissures and prevent surgical treatments with high rates of complications.

Multiple Treatment Arms Evaluated?

No

Implementing Agency

Name of Organization:

DHQ Hospital Okara, Pakistan

Type of Organization:

Public Sector, e.g. Government Agency or Ministry

Program Funder

Name of Organization:

It is a non funded study

Type of Organization:

Other

Intervention Timing

Intervention or Program Started at time of Registration?

Yes

Start Date:

01/12/2022

End Date:

08/22/2022

Evaluation Method

Evaluation Method Overview

Primary (or First) Evaluation Method:

Randomized control trial

Other (not Listed) Method:

Additional Evaluation Method (If Any):

Other (not Listed) Method:

Method Details

Details of Evaluation Approach:

This study was a single-blinded randomized controlled trial

Private Details of Evaluation Approach:

Outcomes (Endpoints):

Healing of anal fissure and pain relief

Unit of Analysis:

complete healing of fissure and presence of scar at fissure site and VAS score to evaluate pain

Hypotheses:

Metronidazole use can hasten anal fissure healing and relieve pain effectively in conjunction with Glyceryl Trinitrate as compared to Glyceryl Trinitrate alone.

Unit of Intervention or Assignment:

Number of Clusters in Sample:

1

Number of Individuals in Sample:

140

Size of Treatment, Control, or Comparison Subsamples:

2 groups with 70 patients in each group

Supplementary Files

Analysis Plan:

Other Documents:

IRB Letter from hospital ethical committee: CamScanner 11-14-2022 14.34.pdf

Data

Outcomes Data

Description:

Patients were randomized and prescribed treatment in OPD and were called for follow-up and then evaluated results

Data Already Collected?

Yes

Data Previously Used?

No

Data Access:

Not restricted - access with no requirements or minimal requirements (e.g. web registration)

Data Obtained by the Study Researchers?

No

Data Approval Process:

Approval Status:

Treatment Assignment Data

Participation or Assignment Information:

Yes

Description:

Data Obtained by the Study Researchers?

Data Previously Used?

Data Access:

Data Obtained by the Study Researchers?

Data Approval Process:

Approval Status:

Data Analysis

Data Analysis Status:

Study Materials

Upload Study Materials:

Registration Category

Registration Category:

Prospective, Category 2: Data for measuring impacts have been collected by others but not obtained or analyzed by the research team

Completion

Completion Overview

Intervention Completion Date:

Data Collection Completion Date:

Unit of Analysis:

Clusters in Final Sample:

Total Observations in Final Sample:

Size of Treatment, Control, or Comparison Subsamples:

Findings

Preliminary Report:

Preliminary Report URL:

Summary of Findings:

Paper:

Paper Summary:

Paper Citation:

Data Availability

Data Availability (Primary Data):

Date of Data Availability:

Data URL or Contact:

Access procedure:

Other Materials

Survey:

Survey Instrument Links or Contact:

Program Files:

Program Files Links or Contact:

External Link:

External Link Description:

Description of Changes:

Study Stopped

Date:

Reason: