SILS™ Port Laparoscopic Cholecystectomy Post Market Study
- Conditions
- Gallbladder Disease
- Interventions
- Procedure: SILS™ port laparoscopic cholecystectomyProcedure: Four Port Laparoscopic Cholecystectomy
- Registration Number
- NCT00832767
- Lead Sponsor
- Medtronic - MITG
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 202
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SILS Port SILS™ port laparoscopic cholecystectomy SILS™ Port Laparoscopic Cholecystectomy Four Port Four Port Laparoscopic Cholecystectomy Four Port Laparoscopic Cholecystectomy
- Primary Outcome Measures
Name Time Method Feasibility and Safety of SILS™ Port Cholecystectomy Versus 4PLC One year Feasibility and safety as determined by intraoperative and postoperative adverse events.
Operative Time Day 0 Duration of surgical procedure in minutes.
Estimated Blood Loss Day 0 Blood loss from surgical procedure in cc.
- Secondary Outcome Measures
Name Time Method 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) 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).
Body Image Scale Various (1 Week, 2 Week, 1 Month, 3 Month and 1 Year) 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.
Cosmetic Scale Various (1 Week, 2 Week, 1 Month, 3 Month and 1 Year) 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.
Confidence Scale Change From Baseline Change from Baseline (Pre-Op) at 1 Week, 2 Week, 1 Month, 3 Month and 1 Year 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.Mental Quality of Life Various (Baseline (Pre-Op), Day 1, 3, 5 and 1 Week) 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 to Cannulization Day 0 Time required to insert SILS port system or 4 individual ports was captured for each procedure in minutes.
Normalized Scar Scores Various (1 Week, 2 Week, 1 Month, 3 Month and 1 Year) 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.Modified Hollander Various (1 Week, 2 Week, 1 Month, 3 Month and 1 Year) 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.
Physical Quality of Life Various (Baseline (Pre-Op), Day 1, 3, 5 and 1 Week) 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.
Trial Locations
- Locations (10)
Yale New Haven Medical Center
🇺🇸New Haven, Connecticut, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Catholic University of Sacred Heart
🇮🇹Rome, Italy
St. Francis Hospital
🇺🇸Roslyn, New York, United States
Imperial College, England, St. Mary's Hospital
🇬🇧London, United Kingdom
North Shore - Long Island Jewish Health System
🇺🇸Lake Success, New York, United States
Case Medical Center
🇺🇸Cleveland, Ohio, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States