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Single-site robotic cholecystectomy versus four-port laparoscopic cholecystectomy in patients with cholelithiasis or gallbladder polyps: a prospective, randomized, double blind study.

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.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614000119695
Acronym
SILC
Enrollment
60
Registered
2014-01-31
Start date
2011-09-15
Completion date
2013-05-30
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

Andrea Pietrabissa
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 15, 2026