SILS™ Port Laparoscopic Cholecystectomy Post Market Study
Prospective Randomized Controlled Trial of Traditional Laparoscopic Cholecystectomy Versus SILS™ Port Laparoscopic Cholecystectomy
1 other identifier
interventional
202
3 countries
10
Brief Summary
The objectives of this trial are:
- 1.to assess the feasibility and safety of performing SILS™ Port Laparoscopic Cholecystectomy
- 2.monitor and compare the outcomes of SILS™ Port Laparoscopic Cholecystectomy versus 4PLC to objectively document the scientific merit and the perceived advantages of SILS™ Port Laparoscopic Cholecystectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2009
Typical duration for not_applicable
10 active sites
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
First Submitted
Initial submission to the registry
January 29, 2009
CompletedFirst Posted
Study publicly available on registry
January 30, 2009
CompletedStudy Start
First participant enrolled
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedResults Posted
Study results publicly available
December 18, 2017
CompletedDecember 18, 2017
May 1, 2017
2.4 years
January 29, 2009
November 11, 2014
May 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Feasibility and Safety of SILS™ Port Cholecystectomy Versus 4PLC
Feasibility and safety as determined by intraoperative and postoperative adverse events.
One year
Operative Time
Duration of surgical procedure in minutes.
Day 0
Estimated Blood Loss
Blood loss from surgical procedure in cc.
Day 0
Secondary Outcomes (9)
Average Pain Experienced in the Last 24 Hours at Various Time Frames
Various (Pre-operative, Day 0, 1,3, 5, 1 Week, 2 Week and 1 Month)
Body Image Scale
Various (1 Week, 2 Week, 1 Month, 3 Month and 1 Year)
Cosmetic Scale
Various (1 Week, 2 Week, 1 Month, 3 Month and 1 Year)
Confidence Scale Change From Baseline
Change from Baseline (Pre-Op) at 1 Week, 2 Week, 1 Month, 3 Month and 1 Year
Normalized Scar Scores
Various (1 Week, 2 Week, 1 Month, 3 Month and 1 Year)
- +4 more secondary outcomes
Study Arms (2)
SILS Port
ACTIVE COMPARATORSILS™ Port Laparoscopic Cholecystectomy
Four Port
ACTIVE COMPARATORFour Port Laparoscopic Cholecystectomy
Interventions
This interventional arm will have a single incision laparoscopic cholecystectomy procedure.
This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure.
Eligibility Criteria
You may qualify if:
- Between 18 and 85 years old.
- Patient has a diagnosis of biliary colic with documented gallstones or polyps by imaging or Biliary dyskinesia with documented EF \< 30%.
- Body Mass Index (BMI) \< 45 kg/m2.
You may not qualify if:
- Any female patient, who is pregnant, suspected pregnant, or nursing.
- Any patient with acute calculus or acalculous cholecystitis.
- Any patient who has had an upper midline or right sub costal incision.
- Any patient with pre-operative indication for a cholangiogram.
- Any patient with ASA \> 3 with normal liver function.
- Any patient who is undergoing Peritoneal Dialysis (PD).
- Any patient who has an unrepaired umbilical hernia or has had prior umbilical hernia repair.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medtronic - MITGlead
Study Sites (10)
Yale New Haven Medical Center
New Haven, Connecticut, 06510, United States
Tampa General Hospital
Tampa, Florida, 33601, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
North Shore - Long Island Jewish Health System
Lake Success, New York, 11042, United States
St. Francis Hospital
Roslyn, New York, 11576, United States
Case Medical Center
Cleveland, Ohio, 44106, United States
UT Southwestern Medical Center
Dallas, Texas, 75390-8819, United States
Catholic University of Sacred Heart
Rome, Italy
Imperial College, England, St. Mary's Hospital
London, United Kingdom
Related Publications (1)
Solomon D, Shariff AH, Silasi DA, Duffy AJ, Bell RL, Roberts KE. Transvaginal cholecystectomy versus single-incision laparoscopic cholecystectomy versus four-port laparoscopic cholecystectomy: a prospective cohort study. Surg Endosc. 2012 Oct;26(10):2823-7. doi: 10.1007/s00464-012-2253-0. Epub 2012 May 2.
PMID: 22549370DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jessica Carlson
- Organization
- Covidien
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey Marks, MD
Case Medical Center University Hospitals
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2009
First Posted
January 30, 2009
Study Start
April 1, 2009
Primary Completion
September 1, 2011
Study Completion
January 1, 2012
Last Updated
December 18, 2017
Results First Posted
December 18, 2017
Record last verified: 2017-05