Gallbladder DiseasesRCTNCT03160157
Comparing the Outcomes of Laparoscopic Cholecystectomy vs. Robotic Cholecystectomy
An observational study of Gallbladder Diseases, run by University of Illinois Chicago at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gallbladder Diseases
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suitable for elective cholecystectomy with minimally invasive approach
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois Outpatient Care Center (OCC)
Chicago, Illinois, 60612
About this study
Official title: 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).
Read more
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.
Read the 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?
- Conditions
- Gallbladder Diseases
- Medical subject headings
- Gallbladder Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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?)
Measured: 2 years
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?)
Measured: 2 years
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?)
Measured: 2 years
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?)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study startDec 2016
- Primary completionNov 2020
- Study completionNov 2020
Why it stopped: No enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gallbladder DiseasesStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Gangemi, University of Illinois Chicago
- Investigators
- Antonio Gangemi, MD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03160157
- Sponsor's protocol ID
- 2016-0790
- Acronym
- RCT
- Status last verified
- Nov 2020
- First submitted
- 16 May 2017
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Data will be coded and will be analyzed by the research staff only. No IPD will be shared with other researchers.
Publications
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.
PubMed 27435700
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Trial Comparing the Outcomes of Laparoscopic Cholecystectomy vs. Robotic Cholecystectomy
- ClinicalTrials.gov ID
- NCT03160157
- Acronym / sponsor ID
- RCT / 2016-0790
- Conditions
- Gallbladder Diseases
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Nov 2020 (actual)
- Study completion
- Nov 2020 (actual)
- First posted
- 19 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suitable for elective cholecystectomy with minimally invasive approach
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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?)
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
The following outcome will be tracked: biliary injuries (Did the patient have biliary injuries? If so, what?)
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
The following outcome will be tracked: biliary anomalies (did the patient have biliary anomalies? If so, what?)
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
The following outcome will be tracked: blood loss did the patient have blood loss? If so, amount in ml?)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Background: PubMed 27435700Gangemi 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.
- Individual participant dataSharing planned: No. Data will be coded and will be analyzed by the research staff only. No IPD will be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Gangemi, MD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gallbladder Diseases, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03160157, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.