Gallbladder DiseaseNCT00832767
SILS™ Port Laparoscopic Cholecystectomy Post Market Study
A study testing SILS™ port laparoscopic cholecystectomy and Four Port Laparoscopic Cholecystectomy in people with Gallbladder Disease, run by Medtronic - MITG at 10 sites in 3 countries.
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Gallbladder Disease
- What is being tested?
- SILS™ port laparoscopic cholecystectomy and Four Port Laparoscopic Cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 10 sitesin 3 countries
- Study dates
- Apr 2009to Jan 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
United States8 sites
Tufts Medical Center
Boston, Massachusetts, 02111
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Case Medical Center
Cleveland, Ohio, 44106
UT Southwestern Medical Center
Dallas, Texas, 75390-8819
North Shore - Long Island Jewish Health System
Lake Success, New York, 11042
Yale New Haven Medical Center
New Haven, Connecticut, 06510
St. Francis Hospital
Roslyn, New York, 11576
Tampa General Hospital
Tampa, Florida, 33601
United Kingdom1 site
Imperial College, England, St. Mary's Hospital
London
About this study
Official title: Prospective Randomized Controlled Trial of Traditional Laparoscopic Cholecystectomy Versus SILS™ Port Laparoscopic Cholecystectomy
The objectives of this trial are:
- to assess the feasibility and safety of performing SILS™ Port Laparoscopic Cholecystectomy
- 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.
- Conditions
- Gallbladder Disease
- Being tested
- SILS™ port laparoscopic cholecystectomy, Four Port Laparoscopic Cholecystectomy
- Keywords
- Laparoscopic Cholecystectomy, Single Incision Laparoscopic Surgery, Surgical Procedures, Minimally Invasive
- Medical subject headings
- Gallbladder Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SILS™ port laparoscopic cholecystectomyProcedure or surgery
This interventional arm will have a single incision laparoscopic cholecystectomy procedure.
Four Port Laparoscopic CholecystectomyProcedure or surgery
This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure.
| Study group | Role | What they receive |
|---|---|---|
| SILS Port | Active comparator | SILS™ Port Laparoscopic Cholecystectomy Receives: Procedure: SILS™ port laparoscopic cholecystectomy |
| Four Port | Active comparator | Four Port Laparoscopic Cholecystectomy Receives: Procedure: Four Port Laparoscopic Cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and Safety of SILS™ Port Cholecystectomy Versus 4PLC
Feasibility and safety as determined by intraoperative and postoperative adverse events.
Measured: One year
Operative Time
Duration of surgical procedure in minutes.
Measured: Day 0
Estimated Blood Loss
Blood loss from surgical procedure in cc.
Measured: Day 0
Secondary outcomes (9)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2009 (estimated)
- Study startApr 2009
- Primary completionSep 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gallbladder DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Marks, MD, Principal investigator, Case Medical Center University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00832767
- Sponsor's protocol ID
- AS08012
- Status last verified
- May 2017
- First submitted
- 29 Jan 2009
- Last updated
- 18 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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.
PubMed 22549370
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Trial of Traditional Laparoscopic Cholecystectomy Versus SILS™ Port Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT00832767
- Acronym / sponsor ID
- AS08012
- Conditions
- Gallbladder Disease
- Keywords
- Laparoscopic Cholecystectomy, Single Incision Laparoscopic Surgery, Surgical Procedures, Minimally Invasive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 30 Jan 2009 (estimated)
- Results
- Posted 18 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this trial are:
- to assess the feasibility and safety of performing SILS™ Port Laparoscopic Cholecystectomy
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SILS Port | Active comparator | Procedure: SILS™ port laparoscopic cholecystectomySILS™ Port Laparoscopic Cholecystectomy |
| Four Port | Active comparator | Procedure: Four Port Laparoscopic CholecystectomyFour Port Laparoscopic Cholecystectomy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SILS™ port laparoscopic cholecystectomyThis interventional arm will have a single incision laparoscopic cholecystectomy procedure. | Procedure or surgery | SILS Port |
| Four Port Laparoscopic CholecystectomyThis interventional arm will have a traditional four port laparoscopic cholecystectomy procedure. | Procedure or surgery | Four Port |
Primary outcome
Feasibility and Safety of SILS™ Port Cholecystectomy Versus 4PLC
Time frame: One year
Feasibility and safety as determined by intraoperative and postoperative adverse events.
Operative Time
Time frame: Day 0
Duration of surgical procedure in minutes.
Estimated Blood Loss
Time frame: Day 0
Blood loss from surgical procedure in cc.
9 secondary outcomes
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)
Body Image Scale
Time frame: Various (1 Week, 2 Week, 1 Month, 3 Month and 1 Year)
Cosmetic Scale
Time frame: Various (1 Week, 2 Week, 1 Month, 3 Month and 1 Year)
Confidence Scale Change From Baseline
Time frame: Change from Baseline (Pre-Op) at 1 Week, 2 Week, 1 Month, 3 Month and 1 Year
Normalized Scar Scores
Time frame: Various (1 Week, 2 Week, 1 Month, 3 Month and 1 Year)
Modified Hollander
Time frame: Various (1 Week, 2 Week, 1 Month, 3 Month and 1 Year)
Physical Quality of Life
Time frame: Various (Baseline (Pre-Op), Day 1, 3, 5 and 1 Week)
Mental Quality of Life
Time frame: Various (Baseline (Pre-Op), Day 1, 3, 5 and 1 Week)
Time to Cannulization
Time frame: Day 0
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22549370Solomon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Marks, MD principal investigator
Case Medical Center University Hospitals
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SILS™ port laparoscopic cholecystectomy and Four Port Laparoscopic Cholecystectomy in people with Gallbladder Disease, run by Medtronic - MITG at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Italy, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and Safety of SILS™ Port Cholecystectomy Versus 4PLC (time frame: One year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00832767, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2017.