NCT01195285

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

February 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 6, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

April 30, 2012

Status Verified

August 1, 2011

Enrollment Period

1.9 years

First QC Date

September 2, 2010

Last Update Submit

April 27, 2012

Conditions

Biliary DyskinesiaGallstonesCholecystitisCholelithiasis

Keywords

Laparoscopic cholecystectomyQuality of lifeBiliary CholicChronic CholecystitisSymptomatic Cholelithiasis

Outcome Measures

Primary Outcomes (1)

  • Cost associated with performance of the procedure and post-operative care until discharge

    4 weeks

Secondary Outcomes (4)

  • Pain scale reported by patient at discharge, 24 and 48 hours

    24 hours and 48 hours

  • Amount of pain medicine required during 48 hours after surgery

    48 hours

  • Major and minor gastrointestinal surgical complications, including conversion

    4 weeks

  • Quality of Life

    2 weeks and 4 weeks

Study Arms (2)

Single-Incision Laparoscopic Cholecsytectomy (SILS)

ACTIVE COMPARATOR
Procedure: Single-Incision Laparoscopic Surgery cholecystectomy

Traditional Laparoscopic Cholecystectomy (TLC)

ACTIVE COMPARATOR
Procedure: Traditional Laparoscopic Cholecystectomy (TLC)

Interventions

Single-Incision Laparoscopic Surgery cholecystectomyPROCEDURE

Laparoscopic Cholecystectomy

Single-Incision Laparoscopic Cholecsytectomy (SILS)
Traditional Laparoscopic Cholecystectomy (TLC)PROCEDURE

Laparoscopic Cholecystectomy

Traditional Laparoscopic Cholecystectomy (TLC)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Additional procedures planned during same surgery
  • Patient deemed inappropriate for TLC or SILS cholecystectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

Related Publications (3)

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

    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.

    PMID: 19412642BACKGROUND

  • 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.

    PMID: 19031097BACKGROUND

MeSH Terms

Conditions

Biliary DyskinesiaGallstonesCholecystitisCholelithiasis

Condition Hierarchy (Ancestors)

Common Bile Duct DiseasesBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesCholecystolithiasisGallbladder DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Kimberly M Brown, BS, MD

    St. Luke's Hospital, Kansas City, Missouri

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 2, 2010

First Posted

September 6, 2010

Study Start

February 1, 2010

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

April 30, 2012

Record last verified: 2011-08

Locations

US(1)