Chronic Anal FissureNCT03872765
Outcomes of the Use of CO2 (Carbon Dioxide) Laser in the Treatment of Chronic Anal Fissure
A study testing Laser surgery in people with Chronic Anal Fissure, run by University of Nineveh.
Trial summary
Outcomes of using CO2 (Carbon Dioxide) laser in the management of chronic anal fissure as an alternative to conventional methods Read more about this study
- Who is it for?
- Ages 26 to 58 years
- Conditions the study is for
- Chronic Anal Fissure
- What is being tested?
- Laser surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- No sites listed yet
- Study dates
- 14 Jan 2012to 9 Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 26 to 58 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Have chronic anal fissure
Who cannot join
- Acute anal fissure Pregnancy
About this study
Official title: 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
Read the 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.
- Conditions
- Chronic Anal Fissure
- Being tested
- Laser surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser surgeryDevice
Use of CO2 laser to perform surgeries to treat chronic anal fissure
| Study group | Role | What they receive |
|---|---|---|
| Patients with chronic anal fissure | Other | Use of laser in surgery of chronic anal fissure instead of the conventional surgical techniques. Receives: Device: Laser surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 weeks after surgery
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
Measured: 3 weeks
Incontinence after surgery
Lack of control of anal sphincter (Incontinence)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start14 Jan 2012
- Primary completion9 Sep 2014
- Study completion9 Sep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Anal FissureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nineveh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Haidaran, University of Nineveh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03872765
- Sponsor's protocol ID
- 818965
- Status last verified
- Mar 2019
- First submitted
- 13 Jan 2019
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study of Chronic Anal Fissure Management Using CO2 Laser
- ClinicalTrials.gov ID
- NCT03872765
- Acronym / sponsor ID
- 818965
- Conditions
- Chronic Anal Fissure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- University of NinevehUniversity, hospital or other
- Study start
- 14 Jan 2012 (actual)
- Primary completion
- 9 Sep 2014 (actual)
- Study completion
- 9 Sep 2014 (actual)
- First posted
- 13 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic anal fissure | Other | Device: Laser surgeryUse of laser in surgery of chronic anal fissure instead of the conventional surgical techniques. |
Who may qualify
- Ages
- 26 to 58 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Have chronic anal fissure
Key exclusion criteria (1 listed)
- Acute anal fissure Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser surgeryUse of CO2 laser to perform surgeries to treat chronic anal fissure | Device | Patients with chronic anal fissure |
Primary outcome
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)
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
Incontinence after surgery
Time frame: 2 years
Lack of control of anal sphincter (Incontinence)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Laser surgery in people with Chronic Anal Fissure, run by University of Nineveh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score after surgery (Degree of pain) (time frame: 3 weeks after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2019.