Comparing the Outcomes of Laparoscopic Cholecystectomy vs. Robotic Cholecystectomy

Gallbladder Diseases Clinical Trial

— RCT  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03160157
• Other study ID #: 2016-0790
• Status: Withdrawn
• Start date: December 2016
• Est. completion date: November 2020

Study information

• Verified date: November 2020
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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?

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2020
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gallbladder Diseases

Locations

Country	Name	City	State
United States	University of Illinois Outpatient Care Center (OCC)	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

References & Publications (1)

Gangemi A, Danilkowicz R, Elli FE, Bianco F, Masrur M, Giulianotti PC. Could ICG-aided robotic cholecystectomy reduce the rate of open conversion reported with laparoscopic approach? A head to head comparison of the largest single institution studies. J Robot Surg. 2017 Mar;11(1):77-82. doi: 10.1007/s11701-016-0624-6. Epub 2016 Jul 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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?	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?)	2 years
Primary	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?	The following outcome will be tracked: biliary injuries (Did the patient have biliary injuries? If so, what?)	2 years
Primary	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?	The following outcome will be tracked: biliary anomalies (did the patient have biliary anomalies? If so, what?)	2 years
Primary	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?	The following outcome will be tracked: blood loss did the patient have blood loss? If so, amount in ml?)	2 years