Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objectives of this trial are:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SILS Port | Active Comparator | SILS™ Port Laparoscopic Cholecystectomy |
|
| Four Port | Active Comparator | Four Port Laparoscopic Cholecystectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SILS™ port laparoscopic cholecystectomy | Procedure | This interventional arm will have a single incision laparoscopic cholecystectomy procedure. |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Marks, MD | Case Medical Center University Hospitals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Medical Center | New Haven | Connecticut | 06510 | United States | ||
| Tampa General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22549370 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | SILS Port | SILS™ Port Laparoscopic Cholecystectomy SILS™ port laparoscopic cholecystectomy : This interventional arm will have a single incision laparoscopic cholecystectomy procedure. |
| FG001 | Four Port | Four Port Laparoscopic Cholecystectomy Four Port Laparoscopic Cholecystectomy : This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
202 subjects were enrolled and randomized, however 2 subjects opted not to have surgery and were removed from the study prior to the baseline visit. Therefore data is only available on 200 subjects.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SILS Port | SILS™ Port Laparoscopic Cholecystectomy SILS™ port laparoscopic cholecystectomy : This interventional arm will have a single incision laparoscopic cholecystectomy procedure. |
| BG001 | Four Port |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility and Safety of SILS™ Port Cholecystectomy Versus 4PLC | Feasibility and safety as determined by intraoperative and postoperative adverse events. | Posted | Number | Participants | One year |
|
AEs collected from enrollment through end of study which was a period of 1 year.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SILS Port | SILS™ Port Laparoscopic Cholecystectomy SILS™ port laparoscopic cholecystectomy : This interventional arm will have a single incision laparoscopic cholecystectomy procedure. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal hernia | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessica Carlson | Covidien | 203-821-4734 | jessica.carlson@covidien.com |
Not provided
| ID | Term |
|---|---|
| D005705 | Gallbladder Diseases |
| ID | Term |
|---|---|
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Four Port Laparoscopic Cholecystectomy | Procedure | This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure. |
|
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 |
| Tampa |
| Florida |
| 33601 |
| United States |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| North Shore - Long Island Jewish Health System | Lake Success | New York | 11042 | United States |
| St. Francis Hospital | Roslyn | New York | 11576 | United States |
| Case Medical Center | Cleveland | Ohio | 44106 | United States |
| UT Southwestern Medical Center | Dallas | Texas | 75390-8819 | United States |
| Catholic University of Sacred Heart | Rome | Italy |
| Imperial College, England, St. Mary's Hospital | London | United Kingdom |
Four Port Laparoscopic Cholecystectomy
Four Port Laparoscopic Cholecystectomy : This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Operative Time | Duration of surgical procedure in minutes. | One site did not collect the operative time for a patient in the SILS group | Posted | Mean | Standard Deviation | minutes | Day 0 |
|
|
|
| Primary | Estimated Blood Loss | Blood loss from surgical procedure in cc. | Posted | Mean | Standard Deviation | cc | Day 0 |
|
|
|
| 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). | Number includes patients who completed pain evaluation questionnaire. | Posted | Mean | Standard Deviation | units on a scale | Various (Pre-operative, Day 0, 1,3, 5, 1 Week, 2 Week and 1 Month) |
|
|
|
| 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. | The number includes participants who completed the Body Image Questionnaire. | Posted | Mean | Standard Deviation | units on a scale | Various (1 Week, 2 Week, 1 Month, 3 Month and 1 Year) |
|
|
|
| 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. | The number includes participants who completed the Cosmetic Scale | Posted | Mean | Standard Deviation | units on a scale | Various (1 Week, 2 Week, 1 Month, 3 Month and 1 Year) |
|
|
|
| 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. | The number analyzed includes participants who completed questions 9 & 10 on the Body Image Questionnaire. Mean Change from Baseline (Pre-Op). | Posted | Mean | Standard Deviation | units on a scale | Change from Baseline (Pre-Op) at 1 Week, 2 Week, 1 Month, 3 Month and 1 Year |
|
|
|
| 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. | The number includes all participants who completed the Photo Series Questionnaire. | Posted | Mean | Standard Deviation | units on a scale | Various (1 Week, 2 Week, 1 Month, 3 Month and 1 Year) |
|
|
|
| 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. | The number includes all participants where Modified Hollander Score was completed. | Posted | Mean | Standard Deviation | units on a scale | Various (1 Week, 2 Week, 1 Month, 3 Month and 1 Year) |
|
|
|
| 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. | Number includes all participants who completed SF8 Quality of Life Questionnaire. | Posted | Mean | Standard Deviation | units on a scale | Various (Baseline (Pre-Op), Day 1, 3, 5 and 1 Week) |
|
|
|
| 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. | The number includes participants who completed the SF8 questionnaire. | Posted | Mean | Standard Deviation | units on a scale | Various (Baseline (Pre-Op), Day 1, 3, 5 and 1 Week) |
|
|
|
| Secondary | Time to Cannulization | Time required to insert SILS port system or 4 individual ports was captured for each procedure in minutes. | Posted | Mean | Standard Deviation | minutes | Day 0 |
|
|
|
| 15 |
| 119 |
| 44 |
| 119 |
| EG001 | Four Port | Four Port Laparoscopic Cholecystectomy Four Port Laparoscopic Cholecystectomy : This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure. | 5 | 81 | 27 | 81 |
| Abdominal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Angina Pectoris | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Bile Duct Stone | Hepatobiliary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Blood Glucose Increased | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Incisional hernia | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Investigation | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Oxygen saturation decreased | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pain | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Syncope | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Urinary Retention Postoperative | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Urinary Tract infection | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
Not provided
Not provided
| Day 0 (Post-operative) |
|
|
| Day 1 |
|
|
| Day 3 |
|
|
| Day 5 |
|
|
| 1 Week |
|
|
| 2 Weeks |
|
|
| 1 Month |
|
|
| 2 Weeks |
|
|
| 1 Month |
|
|
| 3 Month |
|
|
| 1 Year |
|
|
| 2 Weeks |
|
|
| 1 Month |
|
|
| 3 Month |
|
|
| 1 Year |
|
|
| 2 Weeks |
|
|
| 1 Month |
|
|
| 3 Month |
|
|
| 1 Year |
|
|
| Week 1 Q4 - Q2 |
|
|
| Week 2 Q1 - Q2 |
|
|
| Week 2 Q4 - Q2 |
|
|
| Month 1 Q1 - Q2 |
|
|
| Month 1 Q4 - Q2 |
|
|
| Month 3 Q1 - Q2 |
|
|
| Month 3 Q4 - Q2 |
|
|
| Year 1 Q1 - Q2 |
|
|
| Year 1 Q4 - Q2 |
|
|
| 2 Weeks |
|
|
| 1 Month |
|
|
| 3 Month |
|
|
| 1 Year |
|
|
| Day 1 |
|
|
| Day 3 |
|
|
| Day 5 |
|
|
| 1 Week |
|
|
| Day 1 |
|
|
| Day 3 |
|
|
| Day 5 |
|
|
| 1 Week |
|
|