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NCT04793347 Clinical Trial

Effect of Shock Waves Therapy on Chronic Anal Fissure

Chronic Anal Fissure Clinical Trial

Official title:
Effect of Shock Waves Therapy on Anal Fissure

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04793347
Other study ID # nu5332
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date March 10, 2021
Est. completion date May 30, 2021

Study information
Verified date March 2021
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

the study conducted to assess if there is an effect of Extracorporeal Shock Wave Treatment on anal fissure

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..

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 20
Est. completion date May 30, 2021
Est. primary completion date April 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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,

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• shock master (shock waves device)
device produces shock waves

Locations
Country Name City State
Egypt Amr Giza

Sponsors (2)
Lead Sponsor Collaborator
amr bayoumi salama Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary VAS assessment of pain up to 3 months
Secondary wexener scale assess the constipation up to 3 months
See also
  Status Clinical Trial Phase
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Terminated NCT02158013 - Treatment Of Chronic Anal Fissure N/A
Completed NCT01217515 - Diltiazem Hydrochloride Cream for Anal Fissure Phase 3
Recruiting NCT05117697 - Surgical Treatment of a Chronic Anal Fissure N/A
Completed NCT02527109 - The Effect of Intra-anal Nifedipine, Used As Add-on to Conservative Therapy, on Pain in Patients With Anal Fissure Phase 2/Phase 3
Recruiting NCT03920449 - Postero-lateral Internal Sphincterotomy vs Botulinum Toxin Injection in the Treatment of Chronic Anal Fissure N/A
Completed NCT04166175 - High Dose Multiple Site Injection of Botox Versus Lateral Sphincterotomy in Chronic Analfissure N/A
Completed NCT02395809 - Transcutaneous Posterior Tibial Nerve Stimulation for Treatment of Chronic Anal Fissure N/A
Completed NCT01500889 - Conventional Lateral Internal Sphincterotomy, V-Y Anoplasty and Tailored Lateral Internal Sphincterotomy With V-YF in Treatment of Chronic Anal Fissure(CAF) N/A
Completed NCT01132391 - Perianal Versus Endoanal Application of Glyceryl Trinitrate 0.4% Ointment for Chronic Anal Fissure Phase 3
Completed NCT03872765 - Outcomes of the Use of CO2 (Carbon Dioxide) Laser in the Treatment of Chronic Anal Fissure N/A
Completed NCT00972907 - An Open Label Study to Examine the Effect of Coated Nifedipine Suppository on Anal Fissure Pain and Healing in Human Subjects Phase 1/Phase 2