SILS™ Port Laparoscopic Cholecystectomy Post Market Study

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

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.

Study Overview

• Status: Completed
• Conditions: Gallbladder Disease
• Intervention / Treatment: Procedure: SILS™ port laparoscopic cholecystectomy; Procedure: Four Port Laparoscopic Cholecystectomy

• Study Type: Interventional
• Enrollment (Actual): 202
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy
    • Catholic University Of Sacred Heart
• United Kingdom
  • London, United Kingdom
    • Imperial College, England, St. Mary's Hospital
• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale New Haven Medical Center
  • Florida
    • Tampa, Florida, United States, 33601
      • Tampa General Hospital
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
  • New York
    • Lake Success, New York, United States, 11042
      • North Shore - Long Island Jewish Health System
    • Roslyn, New York, United States, 11576
      • St. Francis Hospital
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Case Medical Center
  • Texas
    • Dallas, Texas, United States, 75390-8819
      • UT Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

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

Collaborators and Investigators

• Sponsor: Medtronic - MITG
• Investigators: Principal Investigator: Jeffrey Marks, MD, Case Medical Center University Hospitals

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: January 29, 2009
• First Submitted That Met QC Criteria: January 29, 2009
• First Posted (Estimate): January 30, 2009

Study Record Updates

• Last Update Posted (Actual): December 18, 2017
• Last Update Submitted That Met QC Criteria: May 22, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Single Incision Laparoscopic Surgery; Laparoscopic Cholecystectomy; Surgical Procedures, Minimally Invasive
• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Gallbladder Diseases
• Other Study ID Numbers: AS08012