NCT02020915

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.

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
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2007

Longer than P75 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
6.2 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 25, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

March 20, 2015

Status Verified

March 1, 2015

Enrollment Period

7.8 years

First QC Date

December 19, 2013

Last Update Submit

March 19, 2015

Conditions

Focus: Anal Incontinence After Lateral Sphincterotomy for Chronic Anal Fissure

Outcome Measures

Primary Outcomes (1)

  • Anal incontinence

    5 years or more

Secondary Outcomes (1)

  • Healing of fissure

    5 years or more

Study Arms (1)

Patients with chronic anal fissure

Patients are included who had previous treatment with diltiazem or glycerol-nitrate and botox injections

Procedure: lateral sphincterotomyProcedure: ultrasound guided lateral sphincterotomy

Interventions

lateral sphincterotomyPROCEDURE
Patients with chronic anal fissure
ultrasound guided lateral sphincterotomyPROCEDURE
Patients with chronic anal fissure

Eligibility Criteria

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

Patients undergoing lateral sphincterotomy for chronic anal fissure

You may qualify if:

  • Patients undergoing lateral sphincterotomy for chronic anal fissure

You may not qualify if:

  • Previous diltiazem treatment og botox injections were not performed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hvidovre University Hospital

Hvidovre, DK-2650, Denmark

RECRUITING

MeSH Terms

Interventions

Lateral Internal Sphincterotomy

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, OperativeSphincterotomyMyotomy

Central Study Contacts

Michael Sørensen, MD

CONTACT

+4538625457michael.soerensen.02@regionh.dk

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

December 19, 2013

First Posted

December 25, 2013

Study Start

October 1, 2007

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

March 20, 2015

Record last verified: 2015-03

Locations

DK(1)