Traditional laparoscopic cholecystectomy versus SILS™ port laparoscopic cholecystectomy
| ISRCTN | ISRCTN74919832 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74919832 |
| ClinicalTrials.gov number | NCT00832767 |
| Secondary identifying numbers | AS08012 |
- 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
Scientific
11100 Euclid Avenue
Mail Stop 5047
Cleveland
44106
United States of America
Study information
| Study design | Randomised controlled single-blind multi-centre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 03/02/2009 |
| Completion date | 01/02/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
- Italy
- United Kingdom
- United States of America
Study participating centre
11100 Euclid Avenue
Cleveland
44106
United States of America
44106
United States of America
Sponsor information
Covidien Surgical Devices (USA)
Industry
Industry
c/o Donna Biracree
60 Middletown Avenue
North Haven
06473
United States of America
| Website | http://www.covidien.com |
|---|---|
"ROR" |
https://ror.org/00grd1h17 |
Funders
Funder type
Industry
Covidien Surgical Devices (USA)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
