Single-Incision Laparoscopic Cholecystectomy Versus Traditional Laparoscopic Cholecystectomy

NCT ID: NCT01195285

Last Updated: 2012-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-01-31

Brief Summary

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This study will compare Single Incision Laparoscopic Surgery (SILS) cholecystectomy to traditional laparoscopic cholecystectomy (LC), focusing on patient-reported outcomes and cost.

Detailed Description

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Single-Incision Laparoscopic Surgery (SILS) is accepted as a form of surgical treatment. Traditional laparoscopic cholecystectomy (TLC) is well tolerated, with a low complication risk and high patient satisfaction; thus a SILS procedure needs to be at least equivalent to be a justifiable replacement, and should not result in higher costs.

Conditions

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Biliary Dyskinesia Gallstones Cholecystitis Cholelithiasis

Keywords

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Laparoscopic cholecystectomy Quality of life Biliary Cholic Chronic Cholecystitis Symptomatic Cholelithiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Single-Incision Laparoscopic Cholecsytectomy (SILS)

Group Type ACTIVE_COMPARATOR

Single-Incision Laparoscopic Surgery cholecystectomy

Intervention Type PROCEDURE

Laparoscopic Cholecystectomy

Traditional Laparoscopic Cholecystectomy (TLC)

Group Type ACTIVE_COMPARATOR

Traditional Laparoscopic Cholecystectomy (TLC)

Intervention Type PROCEDURE

Laparoscopic Cholecystectomy

Interventions

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Single-Incision Laparoscopic Surgery cholecystectomy

Laparoscopic Cholecystectomy

Intervention Type PROCEDURE

Traditional Laparoscopic Cholecystectomy (TLC)

Laparoscopic Cholecystectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patient recommended to undergo cholecystectomy
* Patient age 18-80
* Patient competent to give his/her own informed consent
* Patient speaks English without the need for an interpreter

Exclusion Criteria

* Additional procedures planned during same surgery
* Patient deemed inappropriate for TLC or SILS cholecystectomy
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tyco Healthcare Group LP (d/b/a Covidien)

UNKNOWN

Sponsor Role collaborator

Saint Luke's Health System

OTHER

Sponsor Role lead

Responsible Party

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Saint Luke's Hospital

Principal Investigators

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Kimberly M Brown, BS, MD

Role: PRINCIPAL_INVESTIGATOR

St. Luke's Hospital, Kansas City, Missouri

Locations

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Saint Luke's Hospital of Kansas City

Kansas City, Missouri, United States

Site Status

Countries

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United States

References

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Single-incision Laparoscopic Surgery Launched at St. Louis University Hospital. www.news-medical.net. April, 2009

Reference Type BACKGROUND

Chamberlain RS, Sakpal SV. A comprehensive review of single-incision laparoscopic surgery (SILS) and natural orifice transluminal endoscopic surgery (NOTES) techniques for cholecystectomy. J Gastrointest Surg. 2009 Sep;13(9):1733-40. doi: 10.1007/s11605-009-0902-y. Epub 2009 May 2.

Reference Type BACKGROUND
PMID: 19412642 (View on PubMed)

Hodgett SE, Hernandez JM, Morton CA, Ross SB, Albrink M, Rosemurgy AS. Laparoendoscopic single site (LESS) cholecystectomy. J Gastrointest Surg. 2009 Feb;13(2):188-92. doi: 10.1007/s11605-008-0735-0. Epub 2008 Nov 22.

Reference Type BACKGROUND
PMID: 19031097 (View on PubMed)

Other Identifiers

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09-423

Identifier Type: -

Identifier Source: org_study_id