Gallbladder Disease
Conditions
Keywords
Laparoscopic Cholecystectomy, Single Incision Laparoscopic Surgery, Surgical Procedures, Minimally Invasive
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.
Interventions
This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure.
PROCEDURESILS™ port laparoscopic cholecystectomy
This interventional arm will have a single incision laparoscopic cholecystectomy procedure.
Sponsors
Medtronic - MITG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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). |
| 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. |
| 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. |
| 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. |
Countries
Italy, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SILS Port SILS™ Port Laparoscopic Cholecystectomy
SILS™ port laparoscopic cholecystectomy : This interventional arm will have a single incision laparoscopic cholecystectomy procedure. | 119 |
| Four Port Four Port Laparoscopic Cholecystectomy
Four Port Laparoscopic Cholecystectomy : This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure. | 81 |
| Total | 200 |
Baseline characteristics
| Characteristic | Four Port | Total | SILS Port |
|---|---|---|---|
| Age, Customized | 44.0 years | 44.9 years | 45.8 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 26 Participants | 19 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants | 23 Participants | 12 Participants |
| Race (NIH/OMB) White | 61 Participants | 146 Participants | 85 Participants |
| Sex: Female, Male Female | 57 Participants | 148 Participants | 91 Participants |
| Sex: Female, Male Male | 24 Participants | 52 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 44 / 119 | 27 / 81 |
| serious Total, serious adverse events | 15 / 119 | 5 / 81 |
Outcome results
Primary
Estimated Blood Loss
Blood loss from surgical procedure in cc.
Time frame: Day 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SILS Port | Estimated Blood Loss | 14.9 cc | Standard Deviation 35.5 |
| Four Port | Estimated Blood Loss | 14.1 cc | Standard Deviation 35.4 |
Primary
Feasibility and Safety of SILS™ Port Cholecystectomy Versus 4PLC
Feasibility and safety as determined by intraoperative and postoperative adverse events.
Time frame: One year
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SILS Port | Feasibility and Safety of SILS™ Port Cholecystectomy Versus 4PLC | At least one AE | 53 Participants |
| SILS Port | Feasibility and Safety of SILS™ Port Cholecystectomy Versus 4PLC | At least one SAE | 14 Participants |
| SILS Port | Feasibility and Safety of SILS™ Port Cholecystectomy Versus 4PLC | At least one Device-Related AE or SAE | 6 Participants |
| SILS Port | Feasibility and Safety of SILS™ Port Cholecystectomy Versus 4PLC | At least one procedure-related AE or SAE | 45 Participants |
| Four Port | Feasibility and Safety of SILS™ Port Cholecystectomy Versus 4PLC | At least one procedure-related AE or SAE | 23 Participants |
| Four Port | Feasibility and Safety of SILS™ Port Cholecystectomy Versus 4PLC | At least one AE | 29 Participants |
| Four Port | Feasibility and Safety of SILS™ Port Cholecystectomy Versus 4PLC | At least one Device-Related AE or SAE | 1 Participants |
| Four Port | Feasibility and Safety of SILS™ Port Cholecystectomy Versus 4PLC | At least one SAE | 5 Participants |
Primary
Operative Time
Duration of surgical procedure in minutes.
Time frame: Day 0
Population: One site did not collect the operative time for a patient in the SILS group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SILS Port | Operative Time | 56.8 minutes | Standard Deviation 23.2 |
| Four Port | Operative Time | 45.3 minutes | Standard Deviation 17.1 |
Secondary
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)
Population: Number includes patients who completed pain evaluation questionnaire.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SILS Port | Average Pain Experienced in the Last 24 Hours at Various Time Frames | Pre-operative | 3.1 units on a scale | Standard Deviation 2.7 |
| SILS Port | Average Pain Experienced in the Last 24 Hours at Various Time Frames | Day 0 (Post-operative) | 6.3 units on a scale | Standard Deviation 2.8 |
| SILS Port | Average Pain Experienced in the Last 24 Hours at Various Time Frames | Day 1 | 6.7 units on a scale | Standard Deviation 2.5 |
| SILS Port | Average Pain Experienced in the Last 24 Hours at Various Time Frames | Day 3 | 5.4 units on a scale | Standard Deviation 2.3 |
| SILS Port | Average Pain Experienced in the Last 24 Hours at Various Time Frames | Day 5 | 4.2 units on a scale | Standard Deviation 2.2 |
| SILS Port | Average Pain Experienced in the Last 24 Hours at Various Time Frames | 1 Week | 3.5 units on a scale | Standard Deviation 2.3 |
| SILS Port | Average Pain Experienced in the Last 24 Hours at Various Time Frames | 2 Weeks | 2.0 units on a scale | Standard Deviation 1.5 |
| SILS Port | Average Pain Experienced in the Last 24 Hours at Various Time Frames | 1 Month | 1.8 units on a scale | Standard Deviation 1.9 |
| Four Port | Average Pain Experienced in the Last 24 Hours at Various Time Frames | 1 Month | 1.5 units on a scale | Standard Deviation 1.2 |
| Four Port | Average Pain Experienced in the Last 24 Hours at Various Time Frames | Pre-operative | 3.3 units on a scale | Standard Deviation 2.8 |
| Four Port | Average Pain Experienced in the Last 24 Hours at Various Time Frames | Day 5 | 3.5 units on a scale | Standard Deviation 2.1 |
| Four Port | Average Pain Experienced in the Last 24 Hours at Various Time Frames | Day 0 (Post-operative) | 6.4 units on a scale | Standard Deviation 2.3 |
| Four Port | Average Pain Experienced in the Last 24 Hours at Various Time Frames | 2 Weeks | 1.9 units on a scale | Standard Deviation 1.5 |
| Four Port | Average Pain Experienced in the Last 24 Hours at Various Time Frames | Day 1 | 6.1 units on a scale | Standard Deviation 2 |
| Four Port | Average Pain Experienced in the Last 24 Hours at Various Time Frames | 1 Week | 2.9 units on a scale | Standard Deviation 2 |
| Four Port | Average Pain Experienced in the Last 24 Hours at Various Time Frames | Day 3 | 4.6 units on a scale | Standard Deviation 2.1 |
Secondary
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)
Population: The number includes participants who completed the Body Image Questionnaire.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SILS Port | Body Image Scale | 2 Weeks | 5.6 units on a scale | Standard Deviation 1.4 |
| SILS Port | Body Image Scale | 3 Month | 5.3 units on a scale | Standard Deviation 1 |
| SILS Port | Body Image Scale | 1 Month | 5.5 units on a scale | Standard Deviation 1.5 |
| SILS Port | Body Image Scale | 1 Year | 5.5 units on a scale | Standard Deviation 1.6 |
| SILS Port | Body Image Scale | 1 Week | 5.6 units on a scale | Standard Deviation 1.4 |
| Four Port | Body Image Scale | 1 Year | 5.8 units on a scale | Standard Deviation 1.9 |
| Four Port | Body Image Scale | 1 Week | 5.8 units on a scale | Standard Deviation 1.4 |
| Four Port | Body Image Scale | 2 Weeks | 5.8 units on a scale | Standard Deviation 1.4 |
| Four Port | Body Image Scale | 1 Month | 5.8 units on a scale | Standard Deviation 1.7 |
| Four Port | Body Image Scale | 3 Month | 5.5 units on a scale | Standard Deviation 1.2 |
Secondary
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
Population: The number analyzed includes participants who completed questions 9 \& 10 on the Body Image Questionnaire. Mean Change from Baseline (Pre-Op).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SILS Port | Confidence Scale Change From Baseline | 2 Weeks | 0.7 units on a scale | Standard Deviation 2.3 |
| SILS Port | Confidence Scale Change From Baseline | 3 Month | 1.0 units on a scale | Standard Deviation 2.3 |
| SILS Port | Confidence Scale Change From Baseline | 1 Week | 0.5 units on a scale | Standard Deviation 2.2 |
| SILS Port | Confidence Scale Change From Baseline | 1 Year | 1.1 units on a scale | Standard Deviation 2.3 |
| SILS Port | Confidence Scale Change From Baseline | 1 Month | 0.5 units on a scale | Standard Deviation 2 |
| Four Port | Confidence Scale Change From Baseline | 1 Year | 0.9 units on a scale | Standard Deviation 2.7 |
| Four Port | Confidence Scale Change From Baseline | 2 Weeks | 0.6 units on a scale | Standard Deviation 2.2 |
| Four Port | Confidence Scale Change From Baseline | 1 Month | 0.6 units on a scale | Standard Deviation 1.8 |
| Four Port | Confidence Scale Change From Baseline | 3 Month | 0.6 units on a scale | Standard Deviation 1.8 |
| Four Port | Confidence Scale Change From Baseline | 1 Week | 0.5 units on a scale | Standard Deviation 2.4 |
Secondary
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)
Population: The number includes participants who completed the Cosmetic Scale
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SILS Port | Cosmetic Scale | 2 Weeks | 21.5 units on a scale | Standard Deviation 3.1 |
| SILS Port | Cosmetic Scale | 3 Month | 22.5 units on a scale | Standard Deviation 2.6 |
| SILS Port | Cosmetic Scale | 1 Month | 22.1 units on a scale | Standard Deviation 2.7 |
| SILS Port | Cosmetic Scale | 1 Year | 22.6 units on a scale | Standard Deviation 2.4 |
| SILS Port | Cosmetic Scale | 1 Week | 20.5 units on a scale | Standard Deviation 3.6 |
| Four Port | Cosmetic Scale | 1 Year | 20.2 units on a scale | Standard Deviation 3.7 |
| Four Port | Cosmetic Scale | 1 Week | 18.6 units on a scale | Standard Deviation 3.9 |
| Four Port | Cosmetic Scale | 2 Weeks | 18.5 units on a scale | Standard Deviation 3.9 |
| Four Port | Cosmetic Scale | 1 Month | 19.2 units on a scale | Standard Deviation 3.8 |
| Four Port | Cosmetic Scale | 3 Month | 20.0 units on a scale | Standard Deviation 3.3 |
Secondary
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)
Population: The number includes participants who completed the SF8 questionnaire.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SILS Port | Mental Quality of Life | Day 1 | 49.0 units on a scale | Standard Deviation 11.2 |
| SILS Port | Mental Quality of Life | Day 5 | 52.4 units on a scale | Standard Deviation 7.8 |
| SILS Port | Mental Quality of Life | Day 3 | 51.4 units on a scale | Standard Deviation 8.6 |
| SILS Port | Mental Quality of Life | 1 Week | 52.0 units on a scale | Standard Deviation 8.3 |
| SILS Port | Mental Quality of Life | Baseline (Pre-Op) | 47.2 units on a scale | Standard Deviation 10.9 |
| Four Port | Mental Quality of Life | 1 Week | 53.4 units on a scale | Standard Deviation 7.2 |
| Four Port | Mental Quality of Life | Baseline (Pre-Op) | 49.1 units on a scale | Standard Deviation 9.4 |
| Four Port | Mental Quality of Life | Day 1 | 50.6 units on a scale | Standard Deviation 9.4 |
| Four Port | Mental Quality of Life | Day 3 | 51.3 units on a scale | Standard Deviation 8.6 |
| Four Port | Mental Quality of Life | Day 5 | 53.3 units on a scale | Standard Deviation 7.4 |
Secondary
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)
Population: The number includes all participants where Modified Hollander Score was completed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SILS Port | Modified Hollander | 2 Weeks | 0.15 units on a scale | Standard Deviation 0.48 |
| SILS Port | Modified Hollander | 3 Month | 0.05 units on a scale | Standard Deviation 0.27 |
| SILS Port | Modified Hollander | 1 Month | 0.10 units on a scale | Standard Deviation 0.35 |
| SILS Port | Modified Hollander | 1 Year | 0.12 units on a scale | Standard Deviation 0.46 |
| SILS Port | Modified Hollander | 1 Week | 0.37 units on a scale | Standard Deviation 0.93 |
| Four Port | Modified Hollander | 1 Year | 0.03 units on a scale | Standard Deviation 0.18 |
| Four Port | Modified Hollander | 1 Week | 0.21 units on a scale | Standard Deviation 0.67 |
| Four Port | Modified Hollander | 2 Weeks | 0.06 units on a scale | Standard Deviation 0.29 |
| Four Port | Modified Hollander | 1 Month | 0.14 units on a scale | Standard Deviation 0.51 |
| Four Port | Modified Hollander | 3 Month | 0.01 units on a scale | Standard Deviation 0.12 |
Secondary
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)
Population: The number includes all participants who completed the Photo Series Questionnaire.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SILS Port | Normalized Scar Scores | Week 1 Q1 - Q2 | 2.8 units on a scale | Standard Deviation 2.9 |
| SILS Port | Normalized Scar Scores | Week 1 Q4 - Q2 | 3.1 units on a scale | Standard Deviation 2.9 |
| SILS Port | Normalized Scar Scores | Week 2 Q1 - Q2 | 2.5 units on a scale | Standard Deviation 2.5 |
| SILS Port | Normalized Scar Scores | Week 2 Q4 - Q2 | 2.7 units on a scale | Standard Deviation 2.6 |
| SILS Port | Normalized Scar Scores | Month 1 Q1 - Q2 | 2.8 units on a scale | Standard Deviation 2.3 |
| SILS Port | Normalized Scar Scores | Month 1 Q4 - Q2 | 2.9 units on a scale | Standard Deviation 2.3 |
| SILS Port | Normalized Scar Scores | Month 3 Q1 - Q2 | 3.0 units on a scale | Standard Deviation 2.4 |
| SILS Port | Normalized Scar Scores | Month 3 Q4 - Q2 | 3.0 units on a scale | Standard Deviation 2.4 |
| SILS Port | Normalized Scar Scores | Year 1 Q1 - Q2 | 1.9 units on a scale | Standard Deviation 2 |
| SILS Port | Normalized Scar Scores | Year 1 Q4 - Q2 | 2.0 units on a scale | Standard Deviation 1.9 |
| Four Port | Normalized Scar Scores | Month 3 Q4 - Q2 | 0.1 units on a scale | Standard Deviation 1.3 |
| Four Port | Normalized Scar Scores | Week 1 Q1 - Q2 | 0.9 units on a scale | Standard Deviation 1.9 |
| Four Port | Normalized Scar Scores | Month 1 Q4 - Q2 | 0.2 units on a scale | Standard Deviation 1.9 |
| Four Port | Normalized Scar Scores | Week 1 Q4 - Q2 | 0.6 units on a scale | Standard Deviation 2 |
| Four Port | Normalized Scar Scores | Year 1 Q4 - Q2 | -0.2 units on a scale | Standard Deviation 1.4 |
| Four Port | Normalized Scar Scores | Week 2 Q1 - Q2 | 0.4 units on a scale | Standard Deviation 1.4 |
| Four Port | Normalized Scar Scores | Month 3 Q1 - Q2 | 0.4 units on a scale | Standard Deviation 1.3 |
| Four Port | Normalized Scar Scores | Week 2 Q4 - Q2 | 0.3 units on a scale | Standard Deviation 1.8 |
| Four Port | Normalized Scar Scores | Year 1 Q1 - Q2 | -0.0 units on a scale | Standard Deviation 1.3 |
| Four Port | Normalized Scar Scores | Month 1 Q1 - Q2 | 0.7 units on a scale | Standard Deviation 1.5 |
Secondary
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)
Population: Number includes all participants who completed SF8 Quality of Life Questionnaire.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SILS Port | Physical Quality of Life | Baseline (Pre-Op) | 49.1 units on a scale | Standard Deviation 10.3 |
| SILS Port | Physical Quality of Life | Day 5 | 42.0 units on a scale | Standard Deviation 8.6 |
| SILS Port | Physical Quality of Life | Day 3 | 36.8 units on a scale | Standard Deviation 9.3 |
| SILS Port | Physical Quality of Life | 1 Week | 44.4 units on a scale | Standard Deviation 9.3 |
| SILS Port | Physical Quality of Life | Day 1 | 31.0 units on a scale | Standard Deviation 9.9 |
| Four Port | Physical Quality of Life | 1 Week | 47.5 units on a scale | Standard Deviation 6.5 |
| Four Port | Physical Quality of Life | Baseline (Pre-Op) | 50.1 units on a scale | Standard Deviation 9.2 |
| Four Port | Physical Quality of Life | Day 1 | 31.8 units on a scale | Standard Deviation 8.3 |
| Four Port | Physical Quality of Life | Day 3 | 40.1 units on a scale | Standard Deviation 8.8 |
| Four Port | Physical Quality of Life | Day 5 | 44.1 units on a scale | Standard Deviation 10.6 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SILS Port | Time to Cannulization | 6.3 minutes | Standard Deviation 4.4 |
| Four Port | Time to Cannulization | 6.9 minutes | Standard Deviation 3.9 |