SILS™ Port Laparoscopic Cholecystectomy Post Market Study

Study Overview
=================
Brief Summary
-----------------
The objectives of this trial are: to assess the feasibility and safety of performing SILS™ Port Laparoscopic Cholecystectomy 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.

Official Title
-----------------
Prospective Randomized Controlled Trial of Traditional Laparoscopic Cholecystectomy Versus SILS™ Port Laparoscopic Cholecystectomy

Conditions
-----------------
Gallbladder Disease

Intervention / Treatment
-----------------
* Procedure: SILS™ port laparoscopic cholecystectomy
* Procedure: Four Port Laparoscopic Cholecystectomy


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SILS Port<br>SILS™ Port Laparoscopic Cholecystectomy | Procedure: SILS™ port laparoscopic cholecystectomy<br>* This interventional arm will have a single incision laparoscopic cholecystectomy procedure.<br>|
| Active Comparator: Four Port<br>Four Port Laparoscopic Cholecystectomy | Procedure: Four Port Laparoscopic Cholecystectomy<br>* This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 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. | Various (1 Week, 2 Week, 1 Month, 3 Month and 1 Year) | 
| 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. | 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. | 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. | 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. | 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. | 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. | Day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Laparoscopic Cholecystectomy, Single Incision Laparoscopic Surgery, Surgical Procedures, Minimally Invasive