Ultrasound Guided Lateral Sphincterotomy: Long Term Results

• Conditions: Focus: Anal Incontinence After Lateral Sphincterotomy for Chronic Anal Fissure
• Interventions: Procedure: lateral sphincterotomy; Procedure: ultrasound guided lateral sphincterotomy

• Registration Number: NCT02020915
• Lead Sponsor: Hvidovre University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2013-12-19
• Study First Submitted QC: 2013-12-19
• Study First Posted: 2013-12-25
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-19
• Last Update Posted: 2015-03-20
• Primary Completion: 2015-07
• Study Completion: 2015-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Patients undergoing lateral sphincterotomy for chronic anal fissure

Exclusion Criteria

• Previous diltiazem treatment og botox injections were not performed

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with chronic anal fissure	ultrasound guided lateral sphincterotomy	Patients are included who had previous treatment with diltiazem or glycerol-nitrate and botox injections
Patients with chronic anal fissure	lateral sphincterotomy	Patients are included who had previous treatment with diltiazem or glycerol-nitrate and botox injections

Primary Outcome Measures

Name	Time	Method
Anal incontinence	5 years or more

Secondary Outcome Measures

Name	Time	Method
Healing of fissure	5 years or more

Trial Locations

Locations (1)

Hvidovre University Hospital; 🇩🇰 Hvidovre, Denmark