SILS Cholecystectomy: Cholangiography of the Biliary Tract | NCT01056250

Studies
SILS Cholecystectomy: Cholangiography of the Biliary Tract

NCT01056250

Sponsor

St John of God Hospital, Vienna

Status

Completed

Last Update Posted

May 10, 2011Estimated

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Cholecystolithiasis

Interventions

SILS cholangiography

Countries

Austria

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

ID	Type	Description	Link
SJOG 3	Other Identifier	Ethikkommission

Status Module

Record Verification Date

Jul 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Nov 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Jan 24, 2010

First Submission Date that Met QC Criteria

Jan 25, 2010

First Posted Date

Jan 26, 2010Estimated

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

May 8, 2011

Last Update Posted Date

May 10, 2011Estimated

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

Single Incision Laparoscopic Surgery (SILS) can be performed for different standard operations such as appendectomy and cholecystectomy. During laparoscopic cholecystectomy sometimes a cholangiography (marking the biliary tract with contrast agent) is necessary to identify and preserve relevant structures. The investigators want to evaluate feasibility of performing cholangiography during SILS cholecystectomy.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SILS cholangiography	Other	Performing cholangiography in all patients undergoing SILS cholecystectomy.	Procedure: SILS cholangiography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SILS cholangiography	Procedure	intraoperative	SILS cholangiography

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Feasibility of cholangiography during SILS cholecystectomy		at operation

Secondary Outcomes

Measure	Description	Time Frame
biliary tract injury		2 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

cholecystolithiasis

Exclusion Criteria:

acute cholecystitis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bernhard Dauser, MD	St John of God Hospital, Vienna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St John of God Hospital		Vienna	State of Vienna	1180	Austria

Condition Browse Module

MeSH Terms

ID	Term
D041761	Cholecystolithiasis
D002769	Cholelithiasis

Ancestor Terms

ID	Term
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases
D005705	Gallbladder Diseases

Browse Leaves

Not provided

Browse Branches

Not provided