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SILS™ Port Laparoscopic Cholecystectomy Post Market Study

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ClinicalTrials.gov Identifier: NCT00832767
Recruitment Status : Completed
First Posted : January 30, 2009
Results First Posted : December 18, 2017
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Gallbladder Disease Procedure: SILS™ port laparoscopic cholecystectomy Procedure: Four Port Laparoscopic Cholecystectomy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Prospective Randomized Controlled Trial of Traditional Laparoscopic Cholecystectomy Versus SILS™ Port Laparoscopic Cholecystectomy
Study Start Date : April 2009
Actual Primary Completion Date : September 2011
Actual Study Completion Date : January 2012

Arm Intervention/treatment
Active Comparator: SILS Port
SILS™ Port Laparoscopic Cholecystectomy
Procedure: SILS™ port laparoscopic cholecystectomy
This interventional arm will have a single incision laparoscopic cholecystectomy procedure.
Active Comparator: Four Port
Four Port Laparoscopic Cholecystectomy
Procedure: Four Port Laparoscopic Cholecystectomy
This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure.



Primary Outcome Measures :
  1. Feasibility and Safety of SILS™ Port Cholecystectomy Versus 4PLC [ Time Frame: One year ]
    Feasibility and safety as determined by intraoperative and postoperative adverse events.

  2. Operative Time [ Time Frame: Day 0 ]
    Duration of surgical procedure in minutes.

  3. Estimated Blood Loss [ Time Frame: Day 0 ]
    Blood loss from surgical procedure in cc.


Secondary Outcome Measures :
  1. Average Pain Experienced in the Last 24 Hours at Various Time Frames [ Time Frame: 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).

  2. Body Image Scale [ Time Frame: 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.

  3. Cosmetic Scale [ Time Frame: 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.

  4. Confidence Scale Change From Baseline [ Time Frame: 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.


  5. Normalized Scar Scores [ Time Frame: 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.


  6. Modified Hollander [ Time Frame: 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.

  7. Physical Quality of Life [ Time Frame: 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.


  8. Mental Quality of Life [ Time Frame: 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.


  9. Time to Cannulization [ Time Frame: Day 0 ]
    Time required to insert SILS port system or 4 individual ports was captured for each procedure in minutes.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00832767


Locations
United States, Connecticut
Yale New Haven Medical Center
New Haven, Connecticut, United States, 06510
United States, Florida
Tampa General Hospital
Tampa, Florida, United States, 33601
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
United States, New York
North Shore - Long Island Jewish Health System
Lake Success, New York, United States, 11042
St. Francis Hospital
Roslyn, New York, United States, 11576
United States, Ohio
Case Medical Center
Cleveland, Ohio, United States, 44106
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390-8819
Italy
Catholic University of Sacred Heart
Rome, Italy
United Kingdom
Imperial College, England, St. Mary's Hospital
London, United Kingdom
Sponsors and Collaborators
Medtronic - MITG
Investigators
Principal Investigator: Jeffrey Marks, MD Case Medical Center University Hospitals

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT00832767     History of Changes
Other Study ID Numbers: AS08012
First Posted: January 30, 2009    Key Record Dates
Results First Posted: December 18, 2017
Last Update Posted: December 18, 2017
Last Verified: May 2017

Keywords provided by Medtronic - MITG:
Laparoscopic Cholecystectomy
Single Incision Laparoscopic Surgery
Surgical Procedures, Minimally Invasive

Additional relevant MeSH terms:
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases