NCT03872765

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
236

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 14, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2014

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 13, 2019

Completed
Last Updated

March 13, 2019

Status Verified

March 1, 2019

Enrollment Period

2.7 years

First QC Date

January 13, 2019

Last Update Submit

March 10, 2019

Conditions

Chronic Anal Fissure

Outcome Measures

Primary Outcomes (3)

  • 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)

    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

    3 weeks

  • Incontinence after surgery

    Lack of control of anal sphincter (Incontinence)

    2 years

Study Arms (1)

Patients with chronic anal fissure

OTHER

Use of laser in surgery of chronic anal fissure instead of the conventional surgical techniques.

Device: Laser surgery

Interventions

Laser surgeryDEVICE

Use of CO2 laser to perform surgeries to treat chronic anal fissure

Patients with chronic anal fissure

Eligibility Criteria

Age26 Years - 58 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Have chronic anal fissure

You may not qualify if:

  • Acute anal fissure Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Laser Therapy

Intervention Hierarchy (Ancestors)

TherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant general surgeon, lecturer

Study Record Dates

First Submitted

January 13, 2019

First Posted

March 13, 2019

Study Start

January 14, 2012

Primary Completion

September 9, 2014

Study Completion

September 9, 2014

Last Updated

March 13, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share