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Outcomes of the Use of CO2 (Carbon Dioxide) Laser in the Treatment of Chronic Anal Fissure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03872765
Recruitment Status : Completed
First Posted : March 13, 2019
Last Update Posted : March 13, 2019
Information provided by (Responsible Party):
Ahmed Haidaran, University of Nineveh

Brief Summary:
Outcomes of using CO2 (Carbon Dioxide) laser in the management of chronic anal fissure as an alternative to conventional methods

Condition or disease Intervention/treatment Phase
Chronic Anal Fissure Device: Laser surgery Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 236 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cohort Study of Chronic Anal Fissure Management Using CO2 Laser
Actual Study Start Date : January 14, 2012
Actual Primary Completion Date : September 9, 2014
Actual Study Completion Date : September 9, 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Patients with chronic anal fissure
Use of laser in surgery of chronic anal fissure instead of the conventional surgical techniques.
Device: Laser surgery
Use of CO2 laser to perform surgeries to treat chronic anal fissure

Primary Outcome Measures :
  1. Pain score after surgery (Degree of pain) [ Time Frame: 3 weeks after surgery ]
    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)

  2. Recovery time after surgery (How many days patient takes to recover) [ Time Frame: 3 weeks ]
    Time (How many days) for patient to be able to return to normal life activities after surgery

  3. Incontinence after surgery [ Time Frame: 2 years ]
    Lack of control of anal sphincter (Incontinence)

Information from the National Library of Medicine

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Ages Eligible for Study:   26 Years to 58 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Have chronic anal fissure

Exclusion Criteria:

  • Acute anal fissure Pregnancy

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Responsible Party: Ahmed Haidaran, Consultant general surgeon, lecturer, University of Nineveh Identifier: NCT03872765     History of Changes
Other Study ID Numbers: 818965
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fissure in Ano
Anus Diseases
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases