SILS™ Port Laparoscopic Cholecystectomy Post Market Study

Gallbladder Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00832767
• Other study ID #: AS08012
• Status: Completed
• Phase: N/A
• First received: January 29, 2009
• Last updated: May 22, 2017
• Start date: April 2009
• Est. completion date: January 2012

Study information

• Verified date: May 2017
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: January 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gallbladder Disease
• Gallbladder Diseases

Intervention

Procedure:
• SILS™ port laparoscopic cholecystectomy
This interventional arm will have a single incision laparoscopic cholecystectomy procedure.
• Four Port Laparoscopic Cholecystectomy
This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure.

Locations

Country	Name	City	State
Italy	Catholic University of Sacred Heart	Rome
United Kingdom	Imperial College, England, St. Mary's Hospital	London
United States	Tufts Medical Center	Boston	Massachusetts
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Case Medical Center	Cleveland	Ohio
United States	UT Southwestern Medical Center	Dallas	Texas
United States	North Shore - Long Island Jewish Health System	Lake Success	New York
United States	Yale New Haven Medical Center	New Haven	Connecticut
United States	St. Francis Hospital	Roslyn	New York
United States	Tampa General Hospital	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Countries where clinical trial is conducted

United States,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility and Safety of SILS™ Port Cholecystectomy Versus 4PLC	Feasibility and safety as determined by intraoperative and postoperative adverse events.	One year
Primary	Operative Time	Duration of surgical procedure in minutes.	Day 0
Primary	Estimated Blood Loss	Blood loss from surgical procedure in 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).	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.	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.	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.	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.	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.	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.	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.	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.	Day 0