Clinical trial NCT00832767: SILS™ Port Laparoscopic Cholecystectomy Post Market Study
Official title: Prospective Randomized Controlled Trial of Traditional Laparoscopic Cholecystectomy Versus SILS™ Port Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gallbladder Disease
Keywords: Laparoscopic Cholecystectomy
Single Incision Laparoscopic Surgery
Surgical Procedures, Minimally Invasive
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2009-01-30
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Feasibility and Safety of SILS™ Port Cholecystectomy Versus 4PLC
timeFrame: One year
measure: Operative Time
timeFrame: Day 0
measure: Estimated Blood Loss
timeFrame: Day 0
Secondary outcomes:
measure: Average Pain Experienced in the Last 24 Hours at Various Time Frames
timeFrame: Various (Pre-operative, Day 0, 1,3, 5, 1 Week, 2 Week and 1 Month)
measure: Body Image Scale
timeFrame: Various (1 Week, 2 Week, 1 Month, 3 Month and 1 Year)
measure: Cosmetic Scale
timeFrame: Various (1 Week, 2 Week, 1 Month, 3 Month and 1 Year)
measure: Confidence Scale Change From Baseline
timeFrame: Change from Baseline (Pre-Op) at 1 Week, 2 Week, 1 Month, 3 Month and 1 Year
measure: Normalized Scar Scores
timeFrame: Various (1 Week, 2 Week, 1 Month, 3 Month and 1 Year)
measure: Modified Hollander
timeFrame: Various (1 Week, 2 Week, 1 Month, 3 Month and 1 Year)
measure: Physical Quality of Life
timeFrame: Various (Baseline (Pre-Op), Day 1, 3, 5 and 1 Week)
measure: Mental Quality of Life
timeFrame: Various (Baseline (Pre-Op), Day 1, 3, 5 and 1 Week)
measure: Time to Cannulization
timeFrame: Day 0
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Medical Center
state: Connecticut
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Lake Success
country: United States
facility: North Shore - Long Island Jewish Health System
state: New York
city: Roslyn
country: United States
facility: St. Francis Hospital
state: New York
city: Cleveland
country: United States
facility: Case Medical Center
state: Ohio
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Rome
country: Italy
facility: Catholic University of Sacred Heart
city: London
country: United Kingdom
facility: Imperial College, England, St. Mary's Hospital
Study officials:
affiliation: Case Medical Center University Hospitals
name: Jeffrey Marks, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.