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The Importance of Lateral Internal Sphincterotomy Incision: Parallel or Vertical

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2009 by SB Istanbul Education and Research Hospital.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT00980369
First Posted: September 21, 2009
Last Update Posted: September 21, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
SB Istanbul Education and Research Hospital
  Purpose
The purpose of this study is to determine effective incision type for the treatment of chronic anal fissures.

Condition
Anal Fissure

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Incision Type for Lateral Internal Sphincterotomy

Further study details as provided by SB Istanbul Education and Research Hospital:

Enrollment: 52
Study Start Date: October 2007
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Chronic anal fissures
Group A: with vertical incision Group B: with parallel incision
Parallel incision, vertical insicion

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.
  Eligibility

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Primary care clinic
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00980369


Locations
Turkey
SB Istanbul Education and Research Hospital
Istanbul, Turkey
Sponsors and Collaborators
SB Istanbul Education and Research Hospital
Investigators
Study Chair: Feyzullah Ersoz Istanbul Education and Research Hospital, General surgery clinic
  More Information

Responsible Party: Feyzullah Ersoz - Serkan Sarı, Istanbul Education and Research Hospital
ClinicalTrials.gov Identifier: NCT00980369     History of Changes
Other Study ID Numbers: SBIstanbul
2. General Surgery
First Submitted: September 18, 2009
First Posted: September 21, 2009
Last Update Posted: September 21, 2009
Last Verified: September 2009

Keywords provided by SB Istanbul Education and Research Hospital:
Lateral internal sphincterotomy
Anal fissure
Surgical technique
Incision
Wound healing

Additional relevant MeSH terms:
Surgical Wound
Fissure in Ano
Wounds and Injuries
Anus Diseases
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases