- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03160157
Comparing the Outcomes of Laparoscopic Cholecystectomy vs. Robotic Cholecystectomy (RCT)
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.
Study Overview
Status
Conditions
Detailed Description
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?
Study Type
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60612
- University of Illinois Outpatient Care Center (OCC)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 18 years or older
- 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:
- 17 years of age or younger
- Patient's that do not consent
- 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).
- Patients with robotic equipment unavailable at time of surgery.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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laparoscopic surgical group
Patients suitable for elective cholecystectomy with minimally invasive approach will be consented and randomized into either the robotic or laparoscopic group and both the patient and the operating physician will be notified which technique will be performed. Patients will be randomized to a 1:1 ratio. In order to eliminate bias in randomization, the investigators will be using an online resource available at: https://www.randomizer.org. After randomization, the investigators will complete a chart review that will follow the patients for a total of 30 days. The patient participation will be limited to the consent discussion and potential sign off. There will be no other clinic visits in regards to this research. |
robotic surgical group
Patients suitable for elective cholecystectomy with minimally invasive approach will be consented and randomized into either the robotic or laparoscopic group and both the patient and the operating physician will be notified which technique will be performed. Patients will be randomized to a 1:1 ratio. In order to eliminate bias in randomization, the investigators will be using an online resource available at: https://www.randomizer.org. After randomization, the investigators will complete a chart review that will follow the patients for a total of 30 days. The patient participation will be limited to the consent discussion and potential sign off. There will be no other clinic visits in regards to this research. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine which minimally invasive (small incisions) surgical approach is associated with the best outcomes when performing the removal of the gallbladder (cholecystectomy): laparoscopic or robotic?
Time Frame: 2 years
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The following outcome will be tracked: open conversion (was the patient converted to open surgical procedure for either of the minimally invasive procedures, yes or no?)
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2 years
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Determine which minimally invasive (small incisions) surgical approach is associated with the best outcomes when performing the removal of the gallbladder (cholecystectomy): laparoscopic or robotic?
Time Frame: 2 years
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The following outcome will be tracked: biliary injuries (Did the patient have biliary injuries?
If so, what?)
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2 years
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Determine which minimally invasive (small incisions) surgical approach is associated with the best outcomes when performing the removal of the gallbladder (cholecystectomy): laparoscopic or robotic?
Time Frame: 2 years
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The following outcome will be tracked: biliary anomalies (did the patient have biliary anomalies?
If so, what?)
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2 years
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Determine which minimally invasive (small incisions) surgical approach is associated with the best outcomes when performing the removal of the gallbladder (cholecystectomy): laparoscopic or robotic?
Time Frame: 2 years
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The following outcome will be tracked: blood loss did the patient have blood loss?
If so, amount in ml?)
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2 years
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Collaborators and Investigators
Investigators
- Principal Investigator: Antonio Gangemi, MD, University of Illinois at Chicago
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-0790
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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