NCT00980369

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 21, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

September 21, 2009

Status Verified

September 1, 2009

Enrollment Period

5 months

First QC Date

September 18, 2009

Last Update Submit

September 18, 2009

Conditions

Anal Fissure

Keywords

Lateral internal sphincterotomyAnal fissureSurgical techniqueIncisionWound healing

Study Arms (2)

Chronic anal fissures

Group A: with vertical incision Group B: with parallel incision

Parallel incision, vertical insicion

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Primary care clinic

You may qualify if:

  • Patients undergoing open lateral internal sphincterotomy for chronic anal fissure

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SB Istanbul Education and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fissure in AnoSurgical Wound

Condition Hierarchy (Ancestors)

Anus DiseasesRectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesWounds and Injuries

Study Officials

  • Feyzullah Ersoz

    Istanbul Education and Research Hospital, General surgery clinic

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 18, 2009

First Posted

September 21, 2009

Study Start

October 1, 2007

Primary Completion

March 1, 2008

Study Completion

January 1, 2010

Last Updated

September 21, 2009

Record last verified: 2009-09

Locations

TU(1)