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Completed

NCT Number: NCT00832767

SILS™ Port Laparoscopic Cholecystectomy Post Market Study

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.

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Key information

Conditions

Gallbladder Disease Biliary Tract Diseases Digestive System Diseases Gallbladder Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Catholic University of Sacred Heart, Rome, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SILS™ port laparoscopic cholecystectomy

Procedure

This interventional arm will have a single incision laparoscopic cholecystectomy procedure.

Four Port Laparoscopic Cholecystectomy

Procedure

This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Medtronic - MITG

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Jan 30, 2009
Registry last updated
Dec 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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