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

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ClinicalTrials.gov Identifier: NCT03872765
Recruitment Status : Completed
First Posted : March 13, 2019
Last Update Posted : March 13, 2019
Sponsor:
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
Criteria

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
ClinicalTrials.gov 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