Ultrasound Guided Lateral Sphincterotomy: Long Term Results | NCT02020915

Studies
Ultrasound Guided Lateral Sphincterotomy: Long Term Results

NCT02020915

Sponsor

Hvidovre University Hospital

Status

Unknown status

Last Update Posted

Mar 20, 2015Estimated

Enrollment

28Estimated

Phase

Not provided

Conditions

Focus: Anal Incontinence After Lateral Sphincterotomy for Chronic Anal Fissure

Interventions

lateral sphincterotomy
ultrasound guided lateral sphincterotomy

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Jul 2015Estimated

Completion Date

Jul 2015Estimated

First Submitted Date

Dec 19, 2013

First Submission Date that Met QC Criteria

Dec 19, 2013

First Posted Date

Dec 25, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2015

Last Update Posted Date

Mar 20, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

28Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
lateral sphincterotomy	Procedure		Patients with chronic anal fissure
ultrasound guided lateral sphincterotomy

Measure	Description	Time Frame
Anal incontinence		5 years or more

Measure	Description	Time Frame
Healing of fissure		5 years or more

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing lateral sphincterotomy for chronic anal fissure

Exclusion Criteria:

Previous diltiazem treatment og botox injections were not performed

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing lateral sphincterotomy for chronic anal fissure

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Michael Sørensen, MD	Contact	+4538625457		michael.soerensen.02@regionh.dk

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hvidovre University Hospital	Recruiting	Hvidovre		DK-2650	Denmark

Intervention Browse Module

MeSH Terms

ID	Term
D000074722	Lateral Internal Sphincterotomy

Ancestor Terms

ID	Term
D013505	Digestive System Surgical Procedures
D013514	Surgical Procedures, Operative
D000074432	Sphincterotomy
D000074433	Myotomy

Browse Leaves

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Browse Branches

Not provided