Comparing the Outcomes of Laparoscopic Cholecystectomy vs. Robotic Cholecystectomy



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:1/13/2019
Start Date:December 2016
End Date:December 2020
Contact:Antonio Gangemi, MD
Email:agangemi@uic.edu
Phone:312-355-1493

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Prospective Randomized Controlled Trial Comparing the Outcomes of Laparoscopic Cholecystectomy vs. Robotic Cholecystectomy

This research is being done to examine which minimally invasive surgical approach is
associated with the best outcomes when performing cholecystectomy surgery: laparoscopic or
robotic?

Laparoscopic and robotic approaches are similar surgical procedures using small incisions.
The laparoscopic approach is largely used for the removal of the gallbladder
(cholecystectomy).

At UIC, the investigators perform the majority of the gallbladder surgeries through the
robotic approach and only a few using the laparoscopic approach. The robotic surgical tools
allows the surgeon the same freedom of movement as a human wrist, while using a 3D camera
view.

The laparoscopic and robotic surgical approaches both represent minimally invasive surgery
approach and are associated with less pain, faster recovery and better cosmetic outcomes when
compared to traditional open surgery. It is not currently known which approach is better.

Laparoscopic approach is largely used for cholecystectomy surgery. Here, at UIC, however the
investigators perform many surgeries of the gallbladder through robotic approach.

However, the investigators do also perform this surgery using the laparoscopic approach at
UIC. Laparoscopic and robotic surgery represent both minimally invasive approach and are
associated with less pain, faster recovery and better cosmetic outcomes when compared to
traditional open surgery. The majority of cholecystectomies in USA are still being done with
laparoscopic approach though. However, the number of centers switching to the more
technologically advanced robotic approach is growing exponentially.

A recent paper has been published indicating that the robotic approach may decrease the rate
of open conversion (traditional, open abdomen surgery) in cholecystectomy operations in
comparison to laparoscopic approach1. Open conversion implies removal of the minimally
invasive instruments (straight for laparoscopy and robotic with Endowrist® feature) from the
patient's abdominal cavity and the creation of a large incision that starts in the midline,
2-5 cm below the xiphoid bone, extending in parallel with the costal margin for about 20 cm
and going toward the right flank.

There is sparse literature comparing outcomes of cholecystectomy between the laparoscopic and
robotic approaches and no other major studies that focus on just this procedure.

The investigators have already investigated the outcomes of robotic gallbladder surgery vs.
laparoscopic surgery and published these data in a retrospective study, however the
investigators are unsure if a prospective study would yield similar results.

Specific Aim:

The investigators would like to start a prospective randomized study to achieve definitive
scientific evidence that will help determine which minimally invasive surgical approach is
associated with the best outcomes when performing the removal of the gallbladder
(cholecystectomy): laparoscopic or robotic?

Inclusion Criteria:

1. 18 years or older

2. Any of the pre-operative diagnoses including chronic cholecystitis, acute
cholecystitis, benign neoplastic disease of the gallbladder or pre-cancerous
conditions of the gallbladder (polyps, adenomyomatosis), symptomatic cholelithiasis,
porcelain gallbladder and biliary dyskinesia.

Exclusion Criteria:

1. 17 years of age or younger

2. Patient's that do not consent

3. Patients in which cholecystectomy is not the primary procedure, patients undergoing
single site laparoscopic or robotic cholecystectomy, pregnant females, and malignant
neoplastic conditions of the gallbladder (e.g. adenocarcinoma).

4. Patients with robotic equipment unavailable at time of surgery.
We found this trial at
1
site
1801 West Taylor Street
Chicago, Illinois 60612
Principal Investigator: Antonio Gangemi, MD
?
mi
from
Chicago, IL
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