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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.
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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.
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Secondary ID [1]
283926
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None
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Universal Trial Number (UTN)
U1111-1152-2743
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Trial acronym
SILC
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Minimally invasive cholecystectomy
290948
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Cholelithiasis
291027
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Gallbladder polyps
291028
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Condition category
Condition code
Surgery
291284
291284
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0
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Surgical techniques
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Oral and Gastrointestinal
291368
291368
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
288615
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Treatment: Surgery
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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24 hours after surgery
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Secondary outcome [1]
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Post-operative pain trend over time based on "total VAS" score and site-specific scores.
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Assessment method [1]
306419
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Timepoint [1]
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6 hours, 24 hours, 7 days and 30 days after surgery
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Secondary outcome [2]
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Cosmetic result measured using a patient satisfaction score from 0 to 10 (0=no satisfaction; 10=complete satisfaction).
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Assessment method [2]
306420
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Timepoint [2]
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30 days after surgery
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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
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomization by computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomization
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
5/09/2011
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Actual
15/09/2011
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Date of last participant enrolment
Anticipated
14/12/2012
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Actual
30/05/2013
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
5758
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Italy
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State/province [1]
5758
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Pavia
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Funding & Sponsors
Funding source category [1]
288571
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Hospital
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Name [1]
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IRCCS Fondazione Policlinico San Matteo
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Address [1]
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Viale Camillo Golgi, 19 - 27100 - Pavia
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Country [1]
288571
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Italy
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Primary sponsor type
Individual
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Name
Andrea Pietrabissa
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Address
S. C. Chirurgia Generale 2
IRCCS Fondazione Policlinico San Matteo
Viale Camillo Golgi, 19 - 27100 - Pavia
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Country
Italy
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Secondary sponsor category [1]
287282
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Individual
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Name [1]
287282
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Luigi Pugliese
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Address [1]
287282
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S. C. Chirurgia Generale 2
IRCCS Fondazione Policlinico San Matteo
Viale Camillo Golgi, 19 - 27100 - Pavia
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Country [1]
287282
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Italy
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Other collaborator category [1]
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Individual
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Name [1]
277768
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Andrea Peri
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Address [1]
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S. C. Chirurgia Generale 2
IRCCS Fondazione Policlinico San Matteo
Viale Camillo Golgi, 19 - 27100 - Pavia
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Country [1]
277768
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Italy
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Other collaborator category [2]
277769
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Individual
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Name [2]
277769
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Alessio Vinci
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Address [2]
277769
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S. C. Chirurgia Generale 2
IRCCS Fondazione Policlinico San Matteo
Viale Camillo Golgi, 19 - 27100 - Pavia
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Country [2]
277769
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Italy
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Other collaborator category [3]
277770
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Individual
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Name [3]
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Francesco Paolo Tinozzi
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Address [3]
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S. C. Chirurgia Generale 2
IRCCS Fondazione Policlinico San Matteo
Viale Camillo Golgi, 19 - 27100 - Pavia
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Country [3]
277770
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Italy
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Other collaborator category [4]
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Individual
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Name [4]
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Eugenia Pellegrino
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Address [4]
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IRCCS Fondazione Policlinico San Matteo
Viale Camillo Golgi, 19 - 27100 - Pavia
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Country [4]
277771
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Italy
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
290434
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Comitato di Bioetica
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Ethics committee address [1]
290434
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IRCCS Fondazione Policlinico San Matteo
Viale Camillo Golgi, 19 - 27100 - Pavia
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Ethics committee country [1]
290434
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Italy
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Date submitted for ethics approval [1]
290434
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Approval date [1]
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22/08/2011
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Ethics approval number [1]
290434
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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.
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Trial website
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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.
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Public notes
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Contacts
Principal investigator
Name
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Prof Andrea Pietrabissa
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Address
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S.C. Chirurgia Generale 2
IRCCS Fondazione Policlinico San Matteo
Viale Camillo Golgi, 19 - 27100 - Pavia
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Country
45654
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Italy
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Phone
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+39 0382 502536
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Fax
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Email
45654
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[email protected]
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Contact person for public queries
Name
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Dr Luigi Pugliese
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Address
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S.C. Chirurgia Generale 2
IRCCS Fondazione Policlinico San Matteo
Viale Camillo Golgi, 19 - 27100 - Pavia
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Country
45655
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Italy
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Phone
45655
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+39 0382 501510
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Fax
45655
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Email
45655
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[email protected]
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Contact person for scientific queries
Name
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Prof Andrea Pietrabissa
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Address
45656
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S.C. Chirurgia Generale 2
IRCCS Fondazione Policlinico San Matteo
Viale Camillo Golgi, 19 - 27100 - Pavia
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Country
45656
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Italy
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Phone
45656
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+39 0382 502536
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Fax
45656
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Email
45656
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[email protected]
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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
Source
Title
Year of Publication
DOI
Embase
Short-term outcomes of single-site robotic cholecystectomy versus four-port laparoscopic cholecystectomy: a prospective, randomized, double-blind trial.
2016
https://dx.doi.org/10.1007/s00464-015-4601-3
N.B. These documents automatically identified may not have been verified by the study sponsor.
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