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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
202
This interventional arm will have a single incision laparoscopic cholecystectomy procedure.
This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure.
Yale New Haven Medical Center
New Haven, Connecticut, United States
Tampa General Hospital
Tampa, Florida, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Feasibility and Safety of SILS™ Port Cholecystectomy Versus 4PLC
Feasibility and safety as determined by intraoperative and postoperative adverse events.
Time frame: One year
Operative Time
Duration of surgical procedure in minutes.
Time frame: Day 0
Estimated Blood Loss
Blood loss from surgical procedure in cc.
Time frame: Day 0
Average Pain Experienced in the Last 24 Hours at Various Time Frames
Pain evaluation as determined by a 10-point pain intensity numerical rating scale (PI-NRS) ranging from 0 (no pain) to 10 (worst possible pain).
Time frame: Various (Pre-operative, Day 0, 1,3, 5, 1 Week, 2 Week and 1 Month)
Body Image Scale
The Body Image Scale consists of Questions 1-5 on the Body Image Questionnaire. Here, subjects were asked to answer each question on a scale from 1 to 4 with 1 being the best. Therefore, a total score of 5-20 was calculated for each patient with 5 being the best.
Time frame: Various (1 Week, 2 Week, 1 Month, 3 Month and 1 Year)
Cosmetic Scale
The Cosmetic Scale consists of Questions 6-8 on the Body Image Questionnaire. Here, patients were asked to answer questions regarding the cosmesis of their own scar (SILS™) or scars (4PLC). The first 2 questions were answered on a scale from 1 to 7 and Question 8 from 1 to 10, both with 1 being the worst. Therefore, a total score of 3-24 was calculated for each patient with 3 being the worst.
Time frame: Various (1 Week, 2 Week, 1 Month, 3 Month and 1 Year)
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Tufts Medical Center
Boston, Massachusetts, United States
North Shore - Long Island Jewish Health System
Lake Success, New York, United States
St. Francis Hospital
Roslyn, New York, United States
Case Medical Center
Cleveland, Ohio, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Catholic University of Sacred Heart
Rome, Italy
Imperial College, England, St. Mary's Hospital
London, United Kingdom
Confidence Scale Change From Baseline
The Confidence Scale consists of Questions 9 and 10 on the Body Image Questionnaire. One question is before procedure and another is after procedure. The Patients were asked to rate their overall confidence before (baseline) and after the procedure. The scores for before/after procedure range from 1 to 10 with 1 being "not very confident" and 10 being "very confident". The score difference from the before/after treatment is compared between the two procedures (4PLC and SILS™) Here, a positive score indicates that patient confidence has increased.
Time frame: Change from Baseline (Pre-Op) at 1 Week, 2 Week, 1 Month, 3 Month and 1 Year
Normalized Scar Scores
Photo Series Questionnaire (PSQ). All subjects were asked to score their own scar (Question 1), then rate 2 standardized photos (one of 4PLC scars and one of a SILS™ scar) (Questions 2 and 3, respectively) and finally rate their own scar again after viewing the photos (Question 4). All scars were rated on a scale from 1 to 10 with 10 being the best. Normalized scores were analyzed for the photo questionnaire. In order to calculate the normalized score, each patient's score of the 4PLC photo was subtracted from their score of their own scar before viewing the photos. the median values were then used to calculate statistical significance. Normalized Scores of Own Scar are reported below: Question 1 - Question 2 (Q1 - Q2) Question 4 - Question 2 (Q4 - Q2) In order to calculate the normalized score for the subject's own scar, Q2 was used as baseline score since Q2 was the score for the conventional procedure 4PLC.
Time frame: Various (1 Week, 2 Week, 1 Month, 3 Month and 1 Year)
Modified Hollander
Surgeons were asked to answer 6 questions regarding the appearance of their subjects' scars. Each patient's score was summed for a total score 0 to 6 with 0 being the best.
Time frame: Various (1 Week, 2 Week, 1 Month, 3 Month and 1 Year)
Physical Quality of Life
SF8 questionnaire was used. This scale measures health and well-being and asks patients to rank their quality of life on a scale of 1 to 5 or a scale of 1 to 6 with 1 being the best and 5 or 6 being the worst. The quality of life questionnaire contains both physical and mental components. The raw scores are translated into one from 0 to 100, with 0 representing a very low level of QoL and 100 representing a higher QoL.
Time frame: Various (Baseline (Pre-Op), Day 1, 3, 5 and 1 Week)
Mental Quality of Life
SF8 scale was used. This scale measures health and well-being and asks patients to rank their quality of life on a scale of 1 to 5 or a scale of 1 to 6 with 1 being the best and 5 or 6 being the worst. The quality of life questionnaire contains both physical and mental components. The raw scores are translated into one from 0 to 100, with 0 representing a very low level of QoL and 100 representing a higher QoL.
Time frame: Various (Baseline (Pre-Op), Day 1, 3, 5 and 1 Week)
Time to Cannulization
Time required to insert SILS port system or 4 individual ports was captured for each procedure in minutes.
Time frame: Day 0