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Effect of Shock Waves Therapy on Chronic Anal Fissure

Primary Purpose

Chronic Anal Fissure

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
shock master (shock waves device)
Sponsored by
amr bayoumi salama
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Anal Fissure

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • patient with chronic anal fissure
  • symptomatic for at least 6 months
  • failed conservative measures

Exclusion Criteria:

  • Pregnant women,
  • cardiac patients,
  • patients with a pacemaker,
  • low molecular heparin or warfarin treatment,
  • neurological disease,

Sites / Locations

  • Amr

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

shock waves

Arm Description

group of patients with anal fissure will be treated with shock waves

Outcomes

Primary Outcome Measures

VAS
assessment of pain

Secondary Outcome Measures

wexener scale
assess the constipation

Full Information

First Posted
March 6, 2021
Last Updated
March 9, 2021
Sponsor
amr bayoumi salama
Collaborators
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04793347
Brief Title
Effect of Shock Waves Therapy on Chronic Anal Fissure
Official Title
Effect of Shock Waves Therapy on Anal Fissure
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 10, 2021 (Anticipated)
Primary Completion Date
April 30, 2021 (Anticipated)
Study Completion Date
May 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
amr bayoumi salama
Collaborators
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
the study conducted to assess if there is an effect of Extracorporeal Shock Wave Treatment on anal fissure
Detailed Description
Design of the study: A prospective, randomized, blind, paired (right/left) comparison. Materials: Measurement tool: healing of anal fissure, Wexner Constipation Scoring System anal pain intensity by means of a 10-point visual analogue scale (VAS) Therapeutic instruments: •. shock waves • topical application of 0.4% glyceryl trinitrate (GTN) ointment Methods: • Testing procedures: The assessment will be performed before commencing treatment, after 4 and 8 weeks of the treatment. • Treatment procedures: Patients will be assigned randomly into two groups equal in number: shock waves Group: twenty patients will receive the shockwaves on perianal area of for 4 weeks (3 sessions /week). control Group: twenty patients will receive the recommended routine medical treatment include topical application of 0.4% glyceryl trinitrate (GTN) ointment only..

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
shock waves
Arm Type
Experimental
Arm Description
group of patients with anal fissure will be treated with shock waves
Intervention Type
Device
Intervention Name(s)
shock master (shock waves device)
Intervention Description
device produces shock waves
Primary Outcome Measure Information:
Title
VAS
Description
assessment of pain
Time Frame
up to 3 months
Secondary Outcome Measure Information:
Title
wexener scale
Description
assess the constipation
Time Frame
up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: patient with chronic anal fissure symptomatic for at least 6 months failed conservative measures Exclusion Criteria: Pregnant women, cardiac patients, patients with a pacemaker, low molecular heparin or warfarin treatment, neurological disease,
Facility Information:
Facility Name
Amr
City
Giza
ZIP/Postal Code
12613
Country
Egypt

12. IPD Sharing Statement

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Effect of Shock Waves Therapy on Chronic Anal Fissure

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