Prospective Multi-Center Study of Short-Term Outcomes After Complex Cholecystectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

186 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-05

Study Completion Date

2025-01-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study aims to evaluate the short-term clinical outcomes after complex robotic-assisted and laparoscopic cholecystectomies.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparing the Outcomes of Laparoscopic Cholecystectomy vs. Robotic Cholecystectomy

NCT03160157

Gallbladder Diseases

WITHDRAWN

Prolonged Versus Delayed Laparoscopic Cholecystectomy for Acute Cholecystitis

NCT05736003

Acute Cholecystitis

COMPLETED NA

Surgical Techniques: Robotic Versus Conventional Laparoscopic Cholecystectomy IN Benign Gallbladder Disease

NCT07119203

Cholecystectomy, Robotic Cholecystectomy, Laparoscopic Cholecystectomy +2 more

RECRUITING NA

Treatment of Choledocolithiasis by Laparoscopic Exploration

NCT04690101

Choledocholithiasis

COMPLETED

Use of Robotics for Cholecystectomy; Retrospective Review of Outcomes, Set Up and Learning Curves

NCT03059745

Cholecystitis Cholelithiasis

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a multi-center cohort study, evaluating short-term clinical outcomes after complex robotic-assisted and laparoscopic cholecystectomies. The primary outcomes include the rate of conversion to open, rate of intra-operative adverse events, the rate of post-operative adverse events relating to the cholecystectomy within 30 days, and re-admissions and re-operations relating to the cholecystectomy within 30 days. In addition, operative time, the rate of use of intra-operative imaging, the hospital length of stay, and pain and QOL scores will be collected as secondary outcomes.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Laparoscopic Cholecystectomy Robotic-assisted Cholecystectomy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Laparoscopic cholecystectomy

Subject has a diagnosis of acute cholecystitis and is admitted through the ER for a laparoscopic cholecystectomy.

Laparoscopic cholecystectomy

Intervention Type PROCEDURE

With the patient under general anesthesia, several small incisions are made in the abdomen. Ports are placed, the abdomen is insufflated, and laparoscopic instruments as well as a laparoscope are inserted to complete the cholecystectomy according to the surgeon's standard practice.

Robotic-assisted cholecystectomy

Subject has a diagnosis of acute cholecystitis and is admitted through the ER for a robotic-assisted cholecystectomy.

Robotic-assisted cholecystectomy

Intervention Type PROCEDURE

With the patient under general anesthesia, several small incisions are made in the abdomen. Ports are placed, the abdomen is insufflated, and the da Vinci Robotic Surgical System (Intuitive) is docked to the patient and used to complete the cholecystectomy according to the surgeon's standard of care.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Laparoscopic cholecystectomy

With the patient under general anesthesia, several small incisions are made in the abdomen. Ports are placed, the abdomen is insufflated, and laparoscopic instruments as well as a laparoscope are inserted to complete the cholecystectomy according to the surgeon's standard practice.

Intervention Type PROCEDURE

Robotic-assisted cholecystectomy

With the patient under general anesthesia, several small incisions are made in the abdomen. Ports are placed, the abdomen is insufflated, and the da Vinci Robotic Surgical System (Intuitive) is docked to the patient and used to complete the cholecystectomy according to the surgeon's standard of care.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Subject is between 18 and 80 years of age at the time of surgery
2. Subject is a candidate for a cholecystectomy
3. Subject has a diagnosis of acute cholecystitis and is being admitted through the Emergency Room (ER)

Exclusion Criteria

1. A single port (single site or single incision procedure) cholecystectomy will be performed
2. Subject will undergo a concomitant procedure
3. Subject is contraindicated for surgery or a minimally invasive approach
4. Subject has a known bleeding or clotting disorder that is not able to be controlled during surgery
5. Pregnant or suspect pregnant
6. Subject is mentally handicapped or has a psychological disorder or severe systematic illness that would preclude compliance with the study requirements or ability to provide informed consent
7. Subject belonging to other vulnerable population, e.g. prisoner or ward of the state
8. Subject is unable to comply with the follow-up visit schedule
9. Subject is currently participating in another research study

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes