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

March 10, 2019 updated by: Ahmed Haidaran, University of Nineveh

Cohort Study of Chronic Anal Fissure Management Using CO2 Laser

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

236

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

26 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have chronic anal fissure

Exclusion Criteria:

  • Acute anal fissure Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
3 weeks after surgery
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 weeks
Incontinence after surgery
Time Frame: 2 years
Lack of control of anal sphincter (Incontinence)
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nineveh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2012

Primary Completion (Actual)

September 9, 2014

Study Completion (Actual)

September 9, 2014

Study Registration Dates

First Submitted

January 13, 2019

First Submitted That Met QC Criteria

March 10, 2019

First Posted (Actual)

March 13, 2019

Study Record Updates

Last Update Posted (Actual)

March 13, 2019

Last Update Submitted That Met QC Criteria

March 10, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 818965

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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