- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00980369
The Importance of Lateral Internal Sphincterotomy Incision: Parallel or Vertical
September 18, 2009 updated by: SB Istanbul Education and Research Hospital
Incision Type for Lateral Internal Sphincterotomy
The purpose of this study is to determine effective incision type for the treatment of chronic anal fissures.
Study Overview
Status
Unknown
Conditions
Detailed Description
The lateral internal sphincterotomy (LIS) technique is considered the optimal surgical treatment for chronic anal fissures (CAFs); however, questions remain regarding the best technique.
The present study investigated whether the type of anoderm incision (vertical or parallel to the anus) affected wound healing, wound-related complications, incontinence and recurrence rates in CAF patients undergoing open LIS.
Study Type
Observational
Enrollment (Actual)
52
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Istanbul, Turkey
- SB Istanbul Education and Research Hospital
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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
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Primary care clinic
Description
Inclusion Criteria:
- Patients undergoing open lateral internal sphincterotomy for chronic anal fissure
Exclusion Criteria:
- Younger than 18 and older than 65 years of age, patients who had undergone no previous medical treatment, patients with a history of perianal interventions, patients with inflammatory bowel disease, diabetic patients, patients on steroids and immunosuppressives, patients with collagen tissue diseases, mentally retarded patients and patients with malignant disorders.
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
Cohorts and Interventions
Group / Cohort |
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Chronic anal fissures
Group A: with vertical incision Group B: with parallel incision
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Parallel incision, vertical insicion
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Feyzullah Ersoz, Istanbul Education and Research Hospital, General surgery clinic
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
October 1, 2007
Primary Completion (ANTICIPATED)
March 1, 2008
Study Completion (ANTICIPATED)
January 1, 2010
Study Registration Dates
First Submitted
September 18, 2009
First Submitted That Met QC Criteria
September 18, 2009
First Posted (ESTIMATE)
September 21, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
September 21, 2009
Last Update Submitted That Met QC Criteria
September 18, 2009
Last Verified
September 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SBIstanbul
- 2. General Surgery
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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