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Single Incision Laparoscopic Surgery (SILS) Versus Laparoscopic Cholecystectomy (SILS)

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ClinicalTrials.gov Identifier: NCT00981604
Recruitment Status : Completed
First Posted : September 22, 2009
Last Update Posted : December 13, 2011
Sponsor:
Information provided by (Responsible Party):
Shawn St. Peter, Children's Mercy Hospital Kansas City

Tracking Information
First Submitted Date  ICMJE September 21, 2009
First Posted Date  ICMJE September 22, 2009
Last Update Posted Date December 13, 2011
Study Start Date  ICMJE August 2009
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2009)
Operative Time [ Time Frame: 1 day ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00981604 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2009)
  • Operative complications [ Time Frame: 2 weeks ]
  • length of hospitalization [ Time Frame: 1 week ]
  • doses of analgesics [ Time Frame: 1 week ]
  • hospital/operation charges [ Time Frame: 1 week ]
  • surgeon perception of difficulty [ Time Frame: 1 day ]
  • cosmetic scores [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Single Incision Laparoscopic Surgery (SILS) Versus Laparoscopic Cholecystectomy
Official Title  ICMJE Single Incision Versus Laparoscopic Cholecystectomy
Brief Summary Prospective randomized trial of single incision versus standard 4 port laparoscopic cholecystectomy. Hypothesis is that the operative time will be longer with single incision.
Detailed Description

This will be a prospective, randomized clinical trial involving patients who present to the hospital with an indication for cholecystectomy. We will offer enrollment to several institutions provided they receive institutional approval.

This will be a definitive trial design. Based on our operative times with SILS compared with our recent experience in standard laparoscopy, a sample size of 60 patients will give us a power of 0.8 with an α of 0.05.

After the procedure, both groups will be managed in the same manner per routine care. They will be discharged when tolerating a regular diet and their pain is well-controlled on oral pain medication.

Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cholelithiasis
  • Biliary Dyskinesia
Intervention  ICMJE
  • Procedure: SILS
    Single Incision Laparoscopic Cholecystectomy
  • Procedure: Standard Laparoscopic Cholecystectomy
    4 port technique
    Other Name: Laparoscopic Cholecystectomy
Study Arms
  • Active Comparator: SILS Cholecystectomy
    Single Incision Laparoscopic Cholecystectomy
    Intervention: Procedure: SILS
  • Active Comparator: Standard Laparoscopic Cholecystectomy
    4 port laparoscopic cholecystectomy
    Intervention: Procedure: Standard Laparoscopic Cholecystectomy
Publications * Ostlie DJ, Juang OO, Iqbal CW, Sharp SW, Snyder CL, Andrews WS, Sharp RJ, Holcomb GW 3rd, St Peter SD. Single incision versus standard 4-port laparoscopic cholecystectomy: a prospective randomized trial. J Pediatr Surg. 2013 Jan;48(1):209-14. doi: 10.1016/j.jpedsurg.2012.10.039.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: September 21, 2009)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date August 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Need for cholecystectomy

Exclusion Criteria:

  • Need for cholangiogram
Sex/Gender
Sexes Eligible for Study: All
Ages 1 Year to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00981604
Other Study ID Numbers  ICMJE 09 07 132
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Shawn St. Peter, Children's Mercy Hospital Kansas City
Study Sponsor  ICMJE Children's Mercy Hospital Kansas City
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Daniel J Ostlie, MD Children's Mercy Hospital Kansas City
PRS Account Children's Mercy Hospital Kansas City
Verification Date December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP