Traditional laparoscopic cholecystectomy versus SILS™ port laparoscopic cholecystectomy

ISRCTN	ISRCTN74919832
DOI	https://doi.org/10.1186/ISRCTN74919832
ClinicalTrials.gov (NCT)	NCT00832767
Protocol serial number	AS08012
Sponsor	Covidien Surgical Devices (USA)
Funder	Covidien Surgical Devices (USA)

Submission date: 13/01/2009
Registration date: 27/02/2009
Last edited: 21/05/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jeffrey Marks
Scientific

11100 Euclid Avenue
Mail Stop 5047
Cleveland
44106
United States of America

Study information

Primary study design	Interventional
Study design	Randomised controlled single-blind multi-centre study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Prospective randomised controlled trial of traditional laparoscopic cholecystectomy versus SILS™ port laparoscopic cholecystectomy
Study acronym	SILS™ Port Laparoscopic Cholecystectomy Study
Study objectives	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(s)	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.
Health condition(s) or problem(s) studied	Acute calculus, acalculous cholecystitis
Intervention	Traditional laparoscopic cholecystectomy versus SILS™ port laparoscopic cholecystectomy
Intervention type	Procedure/Surgery
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	01/02/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	200
Key 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
Key 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
Date of first enrolment	03/02/2009
Date of final enrolment	01/02/2011

Locations

Countries of recruitment

United Kingdom
Italy
United States of America

Study participating centre

11100 Euclid Avenue

Cleveland
44106
United States of America

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes