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Trial registered on ANZCTR


Registration number
ACTRN12614000119695
Ethics application status
Approved
Date submitted
20/01/2014
Date registered
31/01/2014
Date last updated
31/01/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Single-site robotic cholecystectomy versus four-port laparoscopic cholecystectomy in patients with cholelithiasis or gallbladder polyps: a prospective, randomized, double blind study.
Scientific title
A prospective, randomized, double blind study comparing patients with cholelithiasis or gallbladder polyps undergoing elective single-site robotic cholecystectomy or conventional four-port laparoscopic cholecystectomy to investigate whether the former technique may positively affect early post-operative pain as primary outcome.
Secondary ID [1] 283926 0
None
Universal Trial Number (UTN)
U1111-1152-2743
Trial acronym
SILC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Minimally invasive cholecystectomy 290948 0
Cholelithiasis 291027 0
Gallbladder polyps 291028 0
Condition category
Condition code
Surgery 291284 291284 0 0
Surgical techniques
Oral and Gastrointestinal 291368 291368 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single-site robotic cholecystectomy is a novel technique aimed to minimize the surgical trauma by performing the whole intervention through a single access in the umbilicus where a specifically designed port device is placed for instruments and camera insertion. The robotic platform is expected to improve the surgical task due to the several advantages offered by computer-assisted technology with respect of conventional laparoscopy. One of the commonly reported pitfall of robotic surgery is that the overall duration of the procedure may be increased when compared to the traditional approach due to the docking time spent for robot and trocars positioning, while the dissection time is usually unaffected. A single-site robotic cholecystectomy takes about 60 minutes including docking time, on average, depending on surgical team's experience and patients' characteristics.
Intervention code [1] 288615 0
Treatment: Surgery
Comparator / control treatment
Conventional (4 ports) laparoscopic cholecystectomy is the traditional gold-standard approach based on the placement of four abdominal trocars through which the camera and the instruments are inserted. Its duration is variable depending on surgeon's experience and patient's characteristics but it usually takes 45 minutes-1 hour, on average.
Control group
Active

Outcomes
Primary outcome [1] 291283 0
50% reduction of post-operative pain measured using a standard 10-points VAS (Visual Analogue Scale).
"Total VAS", resulting from the sum of the VAS rates measured on each of the four abdominal access site, was mainly evaluated.
Timepoint [1] 291283 0
24 hours after surgery
Secondary outcome [1] 306419 0
Post-operative pain trend over time based on "total VAS" score and site-specific scores.
Timepoint [1] 306419 0
6 hours, 24 hours, 7 days and 30 days after surgery
Secondary outcome [2] 306420 0
Cosmetic result measured using a patient satisfaction score from 0 to 10 (0=no satisfaction; 10=complete satisfaction).
Timepoint [2] 306420 0
30 days after surgery

Eligibility
Key inclusion criteria
Cholelithiasis or gallbladder polyps with no evidence of choledocholithiasis
Age between 18 and 80 years
BMI < 30 Kg/m2
ASA 1 or 2
Ability to adhere to the protocol and give written informed consent
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age < 18 or > 80 years
BMI > 30 Kg/m2
Acute cholecystitis and choledocholithiasis
Gallbladder stone > 3 cm diameter
Previous upper abdominal quadrants or umbilical surgery
Ongoing pregnancy
Hepatic cirrhosis
ASA > or = 3
Allergy to NSAID or paracetamol

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomization by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomization
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculation was based on the primary endpoint (50% reduction of post-operative pain 24 hours after surgery). The use of VAS (Visual Analogue Scale) allows to determine the distribution of pain in patients undergone to conventional laparoscopic cholecystectomy, thus identifying three groups of patients, each provided with different numerosity:
-Mild pain (VAS 0-3): 10%
-Moderate pain (VAS 4-7%): 70%
-Severe pain (VAS 8-10%): 20%
The sum of VAS rates measured 24 hours post-operatively on each of the four access sites (hidden by pieces of dressing tapes at the end of both techniques to blind the patient and the monitor) was considered. Based on the aforementioned experience of pain distribution after conventional laparoscopic cholecystectomy, the hypothesis is that 90% of patients undergone to this technique will complain moderate-severe pain at that time point. Therefore, if a 50% pain reduction is expected in patients with moderate-severe pain within the single-site robotic group (hence shifting from 90% to 45%), the number of patients to be enrolled in each group should have been 28 in order to keep a 5% alpha-error and a power of 90%. Assuming a potential drop-out rate of 7%, 30 patients at least were supposed to be enrolled in each study arm.
Statistical analysis of primary endpoint was performed by comparing the results of the two groups using Fisher's exact test for categorical data while t Student test for continuous data and calculating the difference between proportions of patients with severe or moderate pain along with its relative 95% confidence intervals. The same was done for secondary endpoints where the changes over time of the sum of VAS rates were compared using regression model for repeated measures.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/09/2011
Actual
15/09/2011
Date of last participant enrolment
Anticipated
14/12/2012
Actual
30/05/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 5758 0
Italy
State/province [1] 5758 0
Pavia

Funding & Sponsors
Funding source category [1] 288571 0
Hospital
Name [1] 288571 0
IRCCS Fondazione Policlinico San Matteo
Country [1] 288571 0
Italy
Primary sponsor type
Individual
Name
Andrea Pietrabissa
Address
S. C. Chirurgia Generale 2
IRCCS Fondazione Policlinico San Matteo
Viale Camillo Golgi, 19 - 27100 - Pavia
Country
Italy
Secondary sponsor category [1] 287282 0
Individual
Name [1] 287282 0
Luigi Pugliese
Address [1] 287282 0
S. C. Chirurgia Generale 2
IRCCS Fondazione Policlinico San Matteo
Viale Camillo Golgi, 19 - 27100 - Pavia
Country [1] 287282 0
Italy
Other collaborator category [1] 277768 0
Individual
Name [1] 277768 0
Andrea Peri
Address [1] 277768 0
S. C. Chirurgia Generale 2
IRCCS Fondazione Policlinico San Matteo
Viale Camillo Golgi, 19 - 27100 - Pavia
Country [1] 277768 0
Italy
Other collaborator category [2] 277769 0
Individual
Name [2] 277769 0
Alessio Vinci
Address [2] 277769 0
S. C. Chirurgia Generale 2
IRCCS Fondazione Policlinico San Matteo
Viale Camillo Golgi, 19 - 27100 - Pavia
Country [2] 277769 0
Italy
Other collaborator category [3] 277770 0
Individual
Name [3] 277770 0
Francesco Paolo Tinozzi
Address [3] 277770 0
S. C. Chirurgia Generale 2
IRCCS Fondazione Policlinico San Matteo
Viale Camillo Golgi, 19 - 27100 - Pavia
Country [3] 277770 0
Italy
Other collaborator category [4] 277771 0
Individual
Name [4] 277771 0
Eugenia Pellegrino
Address [4] 277771 0
IRCCS Fondazione Policlinico San Matteo
Viale Camillo Golgi, 19 - 27100 - Pavia
Country [4] 277771 0
Italy

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290434 0
Comitato di Bioetica
Ethics committee address [1] 290434 0
IRCCS Fondazione Policlinico San Matteo
Viale Camillo Golgi, 19 - 27100 - Pavia
Ethics committee country [1] 290434 0
Italy
Date submitted for ethics approval [1] 290434 0
Approval date [1] 290434 0
22/08/2011
Ethics approval number [1] 290434 0

Summary
Brief summary
Randomized studies have failed to demonstrate significant outcome benefit after single-incision laparoscopic cholecystectomy when compared to conventional laparoscopic cholecystectomy. The new robotic single-site platform allows improved stability of instruments and smoother dissection, which might reduce tissue trauma with potential positive effects on local inflammation and postoperative pain.
Two groups of 30 eligible patients were randomized to receive either SIRC or CLC. During the first postoperative week, patients and study monitors were blinded to the type of procedure performed by the application of four pieces of dressing tape at the end of surgery. Site-specific pain was assessed 6 hours postoperatively, and at one, seven and thirty days after surgery, when a 1 to 10 cosmetic score was also administered to patients. Primary endpoint was 50% pain reduction at 24 hours after surgery in single-site robotic group versus conventional laparoscopic group. Secondary endpoint were post-operative pain trend over time based on "total VAS" (the sum of the VAS rates on each abdominal access site) and site-specific VAS values at 6 hours, 24 hours, 7 and 30 days post-operatively and cosmetic result measured with a 0-10 patient satisfaction scale at 30 days after surgery.
Results of this trial showed that single-site robotic technique does not offer any significant reduction of post-operative pain when compared to the conventional laparoscopic procedure. The cosmetic advantage of the single-site robotic
approach is balanced by an increased risk of incisional hernias and higher costs.
Trial website
Trial related presentations / publications
Abstract selected by ESA (European Surgical Association) Editorial Board for presentation at ESA 2014 annual meeting (Athens, Greece, April 24th-26th 2014) and for the following supposed publication of the related manuscript on the Annals of Surgery journal.
Public notes

Contacts
Principal investigator
Name 45654 0
Prof Andrea Pietrabissa
Address 45654 0
S.C. Chirurgia Generale 2
IRCCS Fondazione Policlinico San Matteo
Viale Camillo Golgi, 19 - 27100 - Pavia
Country 45654 0
Italy
Phone 45654 0
+39 0382 502536
Fax 45654 0
Email 45654 0
[email protected]
Contact person for public queries
Name 45655 0
Luigi Pugliese
Address 45655 0
S.C. Chirurgia Generale 2
IRCCS Fondazione Policlinico San Matteo
Viale Camillo Golgi, 19 - 27100 - Pavia
Country 45655 0
Italy
Phone 45655 0
+39 0382 501510
Fax 45655 0
Email 45655 0
[email protected]
Contact person for scientific queries
Name 45656 0
Andrea Pietrabissa
Address 45656 0
S.C. Chirurgia Generale 2
IRCCS Fondazione Policlinico San Matteo
Viale Camillo Golgi, 19 - 27100 - Pavia
Country 45656 0
Italy
Phone 45656 0
+39 0382 502536
Fax 45656 0
Email 45656 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseShort-term outcomes of single-site robotic cholecystectomy versus four-port laparoscopic cholecystectomy: a prospective, randomized, double-blind trial.2016https://dx.doi.org/10.1007/s00464-015-4601-3
N.B. These documents automatically identified may not have been verified by the study sponsor.