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Ultrasound Guided Lateral Sphincterotomy: Long Term Results

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02020915
Recruitment Status : Unknown
Verified March 2015 by Michael Sørensen, Hvidovre University Hospital.
Recruitment status was:  Recruiting
First Posted : December 25, 2013
Last Update Posted : March 20, 2015
Sponsor:
Information provided by (Responsible Party):
Michael Sørensen, 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.

Condition or disease Intervention/treatment
Focus: Anal Incontinence After Lateral Sphincterotomy for Chronic Anal Fissure Procedure: lateral sphincterotomy Procedure: ultrasound guided lateral sphincterotomy

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Study Type : Observational
Estimated Enrollment : 28 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Ultrasound Guided Lateral Sphincterotomy: Long Term Results
Study Start Date : October 2007
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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



Primary Outcome Measures :
  1. Anal incontinence [ Time Frame: 5 years or more ]

Secondary Outcome Measures :
  1. Healing of fissure [ Time Frame: 5 years or more ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing lateral sphincterotomy for chronic anal fissure
Criteria

Inclusion Criteria:

Patients undergoing lateral sphincterotomy for chronic anal fissure

Exclusion Criteria:

  • Previous diltiazem treatment og botox injections were not performed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02020915


Contacts
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Contact: Michael Sørensen, MD +4538625457 michael.soerensen.02@regionh.dk

Locations
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Denmark
Hvidovre University Hospital Recruiting
Hvidovre, Denmark, DK-2650
Contact: Michael Sørensen, MD    +4538625457    michael.soerensen.02@regionh.dk   
Principal Investigator: Michael Sørensen, MD         
Sponsors and Collaborators
Hvidovre University Hospital
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Responsible Party: Michael Sørensen, Consultant, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT02020915    
Other Study ID Numbers: Sphincterotomy MSOE
First Posted: December 25, 2013    Key Record Dates
Last Update Posted: March 20, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Fissure in Ano
Fecal Incontinence
Anus Diseases
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases