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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02020915
Other study ID # Sphincterotomy MSOE
Secondary ID
Status Recruiting
Phase N/A
First received December 19, 2013
Last updated March 19, 2015
Start date October 2007
Est. completion date July 2015

Study information

Verified date March 2015
Source Hvidovre University Hospital
Contact Michael Sørensen, MD
Phone +4538625457
Email michael.soerensen.02@regionh.dk
Is FDA regulated No
Health authority Denmark: Ethics Commitee, Capital Region
Study type Observational

Clinical Trial Summary

Ultrasound guided placement of the knife intersphincteric increases accuracy and safety during sphincterotomy. Secondly 3-D ultrasound visualizes that the internal anal sphincter is divided.


Recruitment information / eligibility

Status Recruiting
Enrollment 28
Est. completion date July 2015
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

Patients undergoing lateral sphincterotomy for chronic anal fissure

Exclusion Criteria:

- Previous diltiazem treatment og botox injections were not performed

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Procedure:
lateral sphincterotomy

ultrasound guided lateral sphincterotomy


Locations

Country Name City State
Denmark Hvidovre University Hospital Hvidovre

Sponsors (1)

Lead Sponsor Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Anal incontinence 5 years or more No
Secondary Healing of fissure 5 years or more No