Ultrasound Guided Lateral Sphincterotomy: Long Term Results

March 19, 2015 updated by: Michael Sørensen, Hvidovre University Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hvidovre, Denmark, DK-2650
        • Recruiting
        • Hvidovre University Hospital
        • Contact:
        • Principal Investigator:
          • Michael Sørensen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing lateral sphincterotomy for chronic anal fissure

Description

Inclusion Criteria:

Patients undergoing lateral sphincterotomy for chronic anal fissure

Exclusion Criteria:

  • Previous diltiazem treatment og botox injections were not performed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Anal incontinence
Time Frame: 5 years or more
5 years or more

Secondary Outcome Measures

Outcome Measure
Time Frame
Healing of fissure
Time Frame: 5 years or more
5 years or more

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hvidovre University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (ANTICIPATED)

July 1, 2015

Study Completion (ANTICIPATED)

July 1, 2015

Study Registration Dates

First Submitted

December 19, 2013

First Submitted That Met QC Criteria

December 19, 2013

First Posted (ESTIMATE)

December 25, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

March 20, 2015

Last Update Submitted That Met QC Criteria

March 19, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sphincterotomy MSOE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Focus: Anal Incontinence After Lateral Sphincterotomy for Chronic Anal Fissure

Clinical Trials on lateral sphincterotomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe