Single Incision Laparoscopic Surgery (SILS) Versus Laparo... | NCT00981604

Studies
Single Incision Laparoscopic Surgery (SILS) Versus Laparoscopic Cholecystectomy

NCT00981604

Sponsor

Children's Mercy Hospital Kansas City

Status

Completed

Last Update Posted

Dec 13, 2011Estimated

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Cholelithiasis
Biliary Dyskinesia

Interventions

SILS
Standard Laparoscopic Cholecystectomy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Aug 2011Actual

Completion Date

Aug 2011Actual

First Submitted Date

Sep 21, 2009

First Submission Date that Met QC Criteria

Sep 21, 2009

First Posted Date

Sep 22, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 12, 2011

Last Update Posted Date

Dec 13, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SILS Cholecystectomy	Active Comparator	Single Incision Laparoscopic Cholecystectomy	Procedure: SILS
Standard Laparoscopic Cholecystectomy	Active Comparator	4 port laparoscopic cholecystectomy	Procedure: Standard Laparoscopic Cholecystectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SILS	Procedure	Single Incision Laparoscopic Cholecystectomy	SILS Cholecystectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Operative Time		1 day

Secondary Outcomes

Measure	Description	Time Frame
Operative complications		2 weeks
length of hospitalization		1 week
doses of analgesics

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Need for cholecystectomy

Exclusion Criteria:

Need for cholangiogram

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Daniel J Ostlie, MD	Children's Mercy Hospital Kansas City	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Mercy Hospital		Kansas City	Missouri	64108	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23331817	Derived	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.

ID	Term
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases
D003137	Common Bile Duct Diseases
D001649	Bile Duct Diseases

ID	Term
D002763	Cholecystectomy
D001662	Biliary Tract Surgical Procedures
D013505	Digestive System Surgical Procedures
D013514	Surgical Procedures, Operative

ID	Term
D002769	Cholelithiasis
D001657	Biliary Dyskinesia