Back to resultsOutcomes of the Use of CO2 (Carbon Dioxide) Laser in the Treatment of Chronic Anal Fissure
Primary Purpose
Chronic Anal Fissure
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Laser surgery
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Anal Fissure
Eligibility Criteria
Inclusion Criteria:
- Have chronic anal fissure
Exclusion Criteria:
- Acute anal fissure Pregnancy
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients with chronic anal fissure
Arm Description
Use of laser in surgery of chronic anal fissure instead of the conventional surgical techniques.
Outcomes
Primary Outcome Measures
Pain score after surgery (Degree of pain)
Record pain after surgery on a scale of 1 to 10 (Range 1-10 with 1 being least pain and 10 greatest pain experienced by patients)
Recovery time after surgery (How many days patient takes to recover)
Time (How many days) for patient to be able to return to normal life activities after surgery
Incontinence after surgery
Lack of control of anal sphincter (Incontinence)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03872765
Brief Title
Outcomes of the Use of CO2 (Carbon Dioxide) Laser in the Treatment of Chronic Anal Fissure
Official Title
Cohort Study of Chronic Anal Fissure Management Using CO2 Laser
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
January 14, 2012 (Actual)
Primary Completion Date
September 9, 2014 (Actual)
Study Completion Date
September 9, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nineveh
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Outcomes of using CO2 (Carbon Dioxide) laser in the management of chronic anal fissure as an alternative to conventional methods
Detailed Description
The use of CO2 laser in management of chronic anal fissure as a new alternative technique. Interventional study of 236 patients. Comparison to other techniques was made with respect to pain scores and healing time.
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
236 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with chronic anal fissure
Arm Type
Other
Arm Description
Use of laser in surgery of chronic anal fissure instead of the conventional surgical techniques.
Intervention Type
Device
Intervention Name(s)
Laser surgery
Intervention Description
Use of CO2 laser to perform surgeries to treat chronic anal fissure
Primary Outcome Measure Information:
Title
Pain score after surgery (Degree of pain)
Description
Record pain after surgery on a scale of 1 to 10 (Range 1-10 with 1 being least pain and 10 greatest pain experienced by patients)
Time Frame
3 weeks after surgery
Title
Recovery time after surgery (How many days patient takes to recover)
Description
Time (How many days) for patient to be able to return to normal life activities after surgery
Time Frame
3 weeks
Title
Incontinence after surgery
Description
Lack of control of anal sphincter (Incontinence)
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
26 Years
Maximum Age & Unit of Time
58 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have chronic anal fissure
Exclusion Criteria:
Acute anal fissure Pregnancy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Outcomes of the Use of CO2 (Carbon Dioxide) Laser in the Treatment of Chronic Anal Fissure
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