Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00832767
Protocol/serial number
AS08012
Study information
Scientific title
Prospective randomised controlled trial of traditional laparoscopic cholecystectomy versus SILS™ port laparoscopic cholecystectomy
Acronym
SILS™ Port Laparoscopic Cholecystectomy Study
Study hypothesis
The objectives of this trial are: 1) to assess the feasibility and safety of performing SILS™ port cholecystectomy, and 2) to monitor and compare the outcomes of SILS™ port cholecystectomy versus 4PLC to objectively document the scientific merit, and the perceived advantages of SILS™ port cholecystectomy.
Ethics approval
Italy: Ethics Committee, Universita Cattolica del Sacro Cuore, approved on 02/12/2008 (ref: Prot.cm.P822 [A.1505]/C.E./2008)
UK: To be submitted to Ethics Committee, Imperial College London, St Mary's Hospital, in January 2009.
USA: University Hospital Case Medical Center, Institutional Review Board for Human Investigations. Approval pending as of 13/01/2009.
Study design
Randomised controlled single-blind multi-centre study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Acute calculus, acalculous cholecystitis
Intervention
Traditional laparoscopic cholecystectomy versus SILS™ port laparoscopic cholecystectomy
Intervention type
Procedure/Surgery
Phase
Phase IV
Drug names
Primary outcome measures
1. Feasibility and safety of SILS™ port cholecystectomy versus four-port traditional laparoscopic cholecystectomy as indicated by intraoperative and postoperative adverse events up to one year
2. Operative time
3. Blood loss
Secondary outcome measures
1. Pain, assessed by the Pain Intensity numerical rating scale at 8 different timepoints within the first month post surgery
2. Cosmesis, assessed at 5 different timepoints between 1 week and 1 year post surgery by the following:
2.1. Modified Hollander scale
2.2. Body image questionnaire
2.3. Photo series questionnaire
3. Quality of life, assessed by the SF-8® and SF-12® Health Survey questionnaires at 7 different timepoints, once prior to surgery and 6 times up to 1 month post surgery
4. Time to return to normal activity
5. Time required for insertion of SILS™ Port compared to 4 standard ports
Overall trial start date
03/02/2009
Overall trial end date
01/02/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. Both males and females, between 18 and 65 years old
2. The patient has a diagnosis of biliary colic with documented gallstones or polyps by imaging or biliary dyskinesia with documented ejection fraction (EF) <30%
3. Body mass index (BMI) <35 kg/m^2
4. The patient or patient's legal representative has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee (IRB/EC) of the respective clinical site
5. The patient agrees to return to the same research facility for all study-required post-procedure follow-up visits
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200
Participant exclusion criteria
1. Any female patient who is pregnant, suspected pregnant, or nursing
2. Any patient with acute calculus or acalculous cholecystitis
3. Any patient who has had an upper midline or right sub costal incision
4. Any patient with pre-operative indication for a cholangiogram
5. Any patient with American Society of Anesthesiologists (ASA) >3 with normal liver function
6. Any patient who is undergoing peritoneal dialysis (PD)
7. Any patient who has an unrepaired umbilical hernia or has had prior umbilical hernia repair
Recruitment start date
03/02/2009
Recruitment end date
01/02/2011
Locations
Countries of recruitment
Italy, United Kingdom, United States of America
Trial participating centre
11100 Euclid Avenue
Cleveland
44106
United States of America
Sponsor information
Organisation
Covidien Surgical Devices (USA)
Sponsor details
c/o Donna Biracree
60 Middletown Avenue
North Haven
06473
United States of America
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Covidien Surgical Devices (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23619321
Publication citations
-
Results
Marks JM, Phillips MS, Tacchino R, Roberts K, Onders R, DeNoto G, Gecelter G, Rubach E, Rivas H, Islam A, Soper N, Paraskeva P, Rosemurgy A, Ross S, Shah S, Single-incision laparoscopic cholecystectomy is associated with improved cosmesis scoring at the cost of significantly higher hernia rates: 1-year results of a prospective randomized, multicenter, single-blinded trial of traditional multiport laparoscopic cholecystectomy vs single-incision laparoscopic cholecystectomy., J. Am. Coll. Surg., 2013, 216, 6, 1037-47; discussion 1047-8, doi: 10.1016/j.jamcollsurg.2013.02.024.