The Importance of Lateral Internal Sphincterotomy Incisio... | NCT00980369

Studies
The Importance of Lateral Internal Sphincterotomy Incision: Parallel or Vertical

NCT00980369

Sponsor

SB Istanbul Education and Research Hospital

Status

Unknown status

Last Update Posted

Sep 21, 2009Estimated

Enrollment

52Actual

Phase

Not provided

Conditions

Anal Fissure

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2. General Surgery

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Mar 2008Estimated

Completion Date

Jan 2010Estimated

First Submitted Date

Sep 18, 2009

First Submission Date that Met QC Criteria

Sep 18, 2009

First Posted Date

Sep 21, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 18, 2009

Last Update Posted Date

Sep 21, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Chronic anal fissures		Group A: with vertical incision Group B: with parallel incision
Parallel incision, vertical insicion

Interventions

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Primary care clinic

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Feyzullah Ersoz	Istanbul Education and Research Hospital, General surgery clinic	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SB Istanbul Education and Research Hospital		Istanbul			Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D005401	Fissure in Ano
D000072836	Surgical Wound

Ancestor Terms

ID	Term
D001004	Anus Diseases
D012002	Rectal Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided