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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00981604
Recruitment Status : Completed
First Posted : September 22, 2009
Last Update Posted : December 13, 2011
Information provided by (Responsible Party):
Shawn St. Peter, Children's Mercy Hospital Kansas City

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.

Condition or disease Intervention/treatment Phase
Cholelithiasis Biliary Dyskinesia Procedure: SILS Procedure: Standard Laparoscopic Cholecystectomy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Incision Versus Laparoscopic Cholecystectomy
Study Start Date : August 2009
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Arm Intervention/treatment
Active Comparator: SILS Cholecystectomy
Single Incision Laparoscopic Cholecystectomy
Procedure: SILS
Single Incision Laparoscopic Cholecystectomy

Active Comparator: Standard Laparoscopic Cholecystectomy
4 port laparoscopic cholecystectomy
Procedure: Standard Laparoscopic Cholecystectomy
4 port technique
Other Name: Laparoscopic Cholecystectomy

Primary Outcome Measures :
  1. Operative Time [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. Operative complications [ Time Frame: 2 weeks ]
  2. length of hospitalization [ Time Frame: 1 week ]
  3. doses of analgesics [ Time Frame: 1 week ]
  4. hospital/operation charges [ Time Frame: 1 week ]
  5. surgeon perception of difficulty [ Time Frame: 1 day ]
  6. cosmetic scores [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Need for cholecystectomy

Exclusion Criteria:

  • Need for cholangiogram

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00981604

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United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
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Principal Investigator: Daniel J Ostlie, MD Children's Mercy Hospital Kansas City

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Shawn St. Peter, MD, Children's Mercy Hospital Kansas City Identifier: NCT00981604     History of Changes
Other Study ID Numbers: 09 07 132
First Posted: September 22, 2009    Key Record Dates
Last Update Posted: December 13, 2011
Last Verified: December 2011
Keywords provided by Shawn St. Peter, Children's Mercy Hospital Kansas City:
Laparoscopic Cholecystectomy
Additional relevant MeSH terms:
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Biliary Dyskinesia
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Pathological Conditions, Anatomical
Common Bile Duct Diseases
Bile Duct Diseases