NCT01056250

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 26, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

May 10, 2011

Status Verified

July 1, 2010

Enrollment Period

1.2 years

First QC Date

January 24, 2010

Last Update Submit

May 8, 2011

Conditions

Cholecystolithiasis

Keywords

cholelithiasis

Outcome Measures

Primary Outcomes (1)

  • Feasibility of cholangiography during SILS cholecystectomy

    at operation

Secondary Outcomes (1)

  • biliary tract injury

    2 weeks

Study Arms (1)

SILS cholangiography

OTHER

Performing cholangiography in all patients undergoing SILS cholecystectomy.

Procedure: SILS cholangiography

Interventions

SILS cholangiographyPROCEDURE

intraoperative

Also known as: LESS, E-NOTES
SILS cholangiography

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • cholecystolithiasis

You may not qualify if:

  • acute cholecystitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St John of God Hospital

Vienna, Vienna, 1180, Austria

Location

MeSH Terms

Conditions

CholecystolithiasisCholelithiasis

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System DiseasesGallbladder Diseases

Study Officials

  • Bernhard Dauser, MD

    St John of God Hospital, Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 24, 2010

First Posted

January 26, 2010

Study Start

September 1, 2009

Primary Completion

November 1, 2010

Study Completion

December 1, 2010

Last Updated

May 10, 2011

Record last verified: 2010-07

Locations

AU(1)