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

Tracking Information

First Received Date ^ICMJE

September 18, 2009

Last Updated Date

September 18, 2009

Start Date ^ICMJE

October 2007

Estimated Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

The Importance of Lateral Internal Sphincterotomy Incision: Parallel or Vertical

Official Title ^ICMJE

Incision Type for Lateral Internal Sphincterotomy

Brief Summary

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

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 ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

Primary care clinic

Condition ^ICMJE

Anal Fissure

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Chronic anal fissures
Group A: with vertical incision Group B: with parallel incision
Parallel incision, vertical insicion

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Enrolling by invitation

Enrollment ^ICMJE

Estimated Completion Date

January 2010

Estimated Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Turkey

Administrative Information

NCT Number ^ICMJE

NCT00980369

Other Study ID Numbers ^ICMJE

SBIstanbul, 2. General Surgery

Has Data Monitoring Committee

Yes

Responsible Party

Feyzullah Ersoz - Serkan Sarı, Istanbul Education and Research Hospital

Study Sponsor ^ICMJE

SB Istanbul Education and Research Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Feyzullah Ersoz

Istanbul Education and Research Hospital, General surgery clinic

Information Provided By

SB Istanbul Education and Research Hospital

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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