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NCT00980369 Clinical Trial

The Importance of Lateral Internal Sphincterotomy Incision: Parallel or Vertical

Anal Fissure Clinical Trial

Official title:
Incision Type for Lateral Internal Sphincterotomy

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT00980369
Other study ID # SBIstanbul
Secondary ID 2. General Surge
Status Enrolling by invitation
Phase N/A
First received September 18, 2009
Last updated September 18, 2009
Start date October 2007
Est. completion date January 2010

Study information
Verified date September 2009
Source SB Istanbul Education and Research Hospital
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Observational

Clinical Trial Summary

The purpose of this study is to determine effective incision type for the treatment of chronic anal fissures.

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 52
Est. completion date January 2010
Est. primary completion date March 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Turkey SB Istanbul Education and Research Hospital Istanbul

Sponsors (1)
Lead Sponsor Collaborator
SB Istanbul Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

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