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

Primary Purpose

Cholelithiasis, Biliary Dyskinesia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SILS
Standard Laparoscopic Cholecystectomy
Sponsored by
Children's Mercy Hospital Kansas City
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholelithiasis focused on measuring SILS, Laparoscopic Cholecystectomy, Children

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Need for cholecystectomy

Exclusion Criteria:

  • Need for cholangiogram

Sites / Locations

  • Children's Mercy Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

SILS Cholecystectomy

Standard Laparoscopic Cholecystectomy

Arm Description

Single Incision Laparoscopic Cholecystectomy

4 port laparoscopic cholecystectomy

Outcomes

Primary Outcome Measures

Operative Time

Secondary Outcome Measures

Operative complications
length of hospitalization
doses of analgesics
hospital/operation charges
surgeon perception of difficulty
cosmetic scores

Full Information

First Posted
September 21, 2009
Last Updated
December 12, 2011
Sponsor
Children's Mercy Hospital Kansas City
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1. Study Identification

Unique Protocol Identification Number
NCT00981604
Brief Title
Single Incision Laparoscopic Surgery (SILS) Versus Laparoscopic Cholecystectomy
Acronym
SILS
Official Title
Single Incision Versus Laparoscopic Cholecystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Mercy Hospital Kansas City

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholelithiasis, Biliary Dyskinesia
Keywords
SILS, Laparoscopic Cholecystectomy, Children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SILS Cholecystectomy
Arm Type
Active Comparator
Arm Description
Single Incision Laparoscopic Cholecystectomy
Arm Title
Standard Laparoscopic Cholecystectomy
Arm Type
Active Comparator
Arm Description
4 port laparoscopic cholecystectomy
Intervention Type
Procedure
Intervention Name(s)
SILS
Intervention Description
Single Incision Laparoscopic Cholecystectomy
Intervention Type
Procedure
Intervention Name(s)
Standard Laparoscopic Cholecystectomy
Other Intervention Name(s)
Laparoscopic Cholecystectomy
Intervention Description
4 port technique
Primary Outcome Measure Information:
Title
Operative Time
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Operative complications
Time Frame
2 weeks
Title
length of hospitalization
Time Frame
1 week
Title
doses of analgesics
Time Frame
1 week
Title
hospital/operation charges
Time Frame
1 week
Title
surgeon perception of difficulty
Time Frame
1 day
Title
cosmetic scores
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Need for cholecystectomy Exclusion Criteria: Need for cholangiogram
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel J Ostlie, MD
Organizational Affiliation
Children's Mercy Hospital Kansas City
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23331817
Citation
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.
Results Reference
derived

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Single Incision Laparoscopic Surgery (SILS) Versus Laparoscopic Cholecystectomy

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