The Importance of Lateral Internal Sphincterotomy Incision: Parallel or Vertical

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
SB Istanbul Education and Research Hospital
ClinicalTrials.gov Identifier:
NCT00980369
First received: September 18, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: September 18, 2009
Last Updated: September 18, 2009
Health Authority: Turkey: Ethics Committee

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

Additional relevant MeSH terms:
Fissure in Ano
Anus Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on October 23, 2014