NCT00981604

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 22, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

December 13, 2011

Status Verified

December 1, 2011

Enrollment Period

2 years

First QC Date

September 21, 2009

Last Update Submit

December 12, 2011

Conditions

CholelithiasisBiliary Dyskinesia

Keywords

SILSLaparoscopic CholecystectomyChildren

Outcome Measures

Primary Outcomes (1)

  • Operative Time

    1 day

Secondary Outcomes (6)

  • Operative complications

    2 weeks

  • length of hospitalization

    1 week

  • doses of analgesics

    1 week

  • hospital/operation charges

    1 week

  • surgeon perception of difficulty

    1 day

  • +1 more secondary outcomes

Study Arms (2)

SILS Cholecystectomy

ACTIVE COMPARATOR

Single Incision Laparoscopic Cholecystectomy

Procedure: SILS

Standard Laparoscopic Cholecystectomy

ACTIVE COMPARATOR

4 port laparoscopic cholecystectomy

Procedure: Standard Laparoscopic Cholecystectomy

Interventions

SILSPROCEDURE

Single Incision Laparoscopic Cholecystectomy

SILS Cholecystectomy
Standard Laparoscopic CholecystectomyPROCEDURE

4 port technique

Also known as: Laparoscopic Cholecystectomy
Standard Laparoscopic Cholecystectomy

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Need for cholecystectomy

You may not qualify if:

  • Need for cholangiogram

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Related Publications (1)

  • 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.

    PMID: 23331817DERIVED

MeSH Terms

Conditions

CholelithiasisBiliary Dyskinesia

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System DiseasesCommon Bile Duct DiseasesBile Duct Diseases

Intervention Hierarchy (Ancestors)

CholecystectomyBiliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, OperativeLaparoscopyEndoscopyMinimally Invasive Surgical Procedures

Study Officials

  • Daniel J Ostlie, MD

    Children's Mercy Hospital Kansas City

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 21, 2009

First Posted

September 22, 2009

Study Start

August 1, 2009

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

December 13, 2011

Record last verified: 2011-12

Locations

US(1)