NCT01146184

Brief Summary

The aim of this study is to improve the technique of laparoscopic cholecystectomy by using a flexible endoscope passed through a single umbilical skin incision, as previously reported, now with the use of Manually Articulating Devices (Ethicon Endo-Surgery, Inc.) through the endoscope.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

1 active site

Status
withdrawn

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

November 1, 2009

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2010

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 17, 2010

Completed
Last Updated

March 7, 2016

Status Verified

August 1, 2015

Enrollment Period

Same day

First QC Date

June 1, 2010

Last Update Submit

March 4, 2016

Conditions

CholelithiasisPain

Keywords

CholelithiasisSingle IncisionFlexible EndoscopeEthicon Manually Articulating DevicePain

Outcome Measures

Primary Outcomes (1)

  • Improving the technique of laparoscopic Cholecystectomy with Flexible Endoscope and Ethicon Manually Articulating Device

    Using flexible endoscopes and the Ethicon Manually Articulating Device will facilitate the procedure of removing the gallbladder by allowing more flexibility and greater movement in the abdominal cavity, better triangulation for dissection and increased quality of optics for the single-incision technique.

    Intra-Operative

Secondary Outcomes (2)

  • Post-operative Pain

    1 month

  • Complications

    1 month

Study Arms (1)

Single-Incision Cholecystectomy

EXPERIMENTAL

Extracting the gallbladder laparoscopically is made difficult through a single incision.

Device: Flexible endoscope and Ethicon Manually Articulating Device

Interventions

Flexible endoscope and Ethicon Manually Articulating DeviceDEVICE

Using the Flexible Endoscope and the Ethicon Manually Articulating Device, removal of the gallbladder through a single incision is improved.

Also known as: Single Incision cholecystectomy using flexible endoscope, Ethicon instruments
Single-Incision Cholecystectomy

Eligibility Criteria

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

You may qualify if:

  • Uncomplicated Biliary Colic
  • ASA I or II

You may not qualify if:

  • Pregnant Women
  • Children
  • Institutionalized mentally disabled
  • Prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Luke's-Roosevelt Hospital Center

New York, New York, 10025, United States

Location

Related Publications (4)

  • Ng WT, Kong CK, Wong YT. One-wound laparoscopic cholecystectomy. Br J Surg. 1997 Nov;84(11):1627. No abstract available.

    PMID: 9393287BACKGROUND

  • Teixeira J, McGill K, Koshy N, McGinty J, Todd G. Laparoscopic single-site surgery for placement of adjustable gastric band--a series of 22 cases. Surg Obes Relat Dis. 2010 Jan-Feb;6(1):41-5. doi: 10.1016/j.soard.2009.03.220. Epub 2009 Apr 16.

    PMID: 19560980BACKGROUND

  • Petersen LR, Doll LS. Human immunodeficiency virus type 1-infected blood donors: epidemiologic, laboratory, and donation characteristics. The HIV Blood Donor Study Group. Transfusion. 1991 Oct;31(8):698-703. doi: 10.1046/j.1537-2995.1991.31892023493.x.

    PMID: 1926312BACKGROUND

  • Slim K, Pezet D, Stencl J Jr, Lechner C, Le Roux S, Lointier P, Chipponi J. Laparoscopic cholecystectomy: an original three-trocar technique. World J Surg. 1995 May-Jun;19(3):394-7. doi: 10.1007/BF00299168.

    PMID: 7638995BACKGROUND

MeSH Terms

Conditions

CholelithiasisPain

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Julio Teixeira, MD

    St Luke's Roosevelt Hospital Center- Surgery Department

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2010

First Posted

June 17, 2010

Study Start

November 1, 2009

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

March 7, 2016

Record last verified: 2015-08

Locations

US(1)