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

NCT04888117 | Completed

• 1 other identifier: COMPaCT
• Study Type: observational
• Target: 186
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Laparoscopic Cholecystectomy; Robotic-assisted Cholecystectomy

Outcome Measures

Primary Outcomes (4)

• Conversion to open

  The rate of conversion of the cholecystectomy to open, defined as robotic-assisted surgery converted to an open approach

  Intra-operative

• Number of adverse events

  Intra-operative or post-operative adverse events related to the cholecystectomy

  Intra-operative through the 30 days follow-up period

• Re-admissions

  Re-admissions to the hospital related to the cholecystectomy through the 30 days follow-up period

  After discharge from the hospital post-procedure through the 30 days follow-up period

• Re-operations

  Re-operations related to the cholecystectomy through 30 days follow-up

  After the procedure but prior to discharge, through the 30 day follow-up period

Secondary Outcomes (8)

• Operative time

  Intra-operative

• Use of intra-operative imaging

  Intra-operative

• Length of hospital stay

  From admission to discharge, up to approximately one week

• Biliary anatomy identification

  Intra-operative

• Change in pain score assessed by the PROMIS 3a from baseline to 14 days

  14 days

Study Arms (2)

Laparoscopic cholecystectomy

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

Procedure: Laparoscopic cholecystectomy

Robotic-assisted cholecystectomy

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

Procedure: Robotic-assisted cholecystectomy

Interventions

Laparoscopic cholecystectomy 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.

Laparoscopic cholecystectomy

Robotic-assisted cholecystectomy 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.

Robotic-assisted cholecystectomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who are eligible based on the inclusion/exclusion criteria may participate in the study. Approximately 100 subjects will be enrolled in each cohort (laparoscopic and robotic-assisted). In each cohort, a maximum of 50% of subjects may be enrolled with a Nassar Grade II, and a minimum of 50% of subjects with either Nassar Grade III or IV may be enrolled.

You may qualify if:

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

You may not qualify if:

• A single port (single site or single incision procedure) cholecystectomy will be performed
• Subject will undergo a concomitant procedure
• Subject is contraindicated for surgery or a minimally invasive approach
• Subject has a known bleeding or clotting disorder that is not able to be controlled during surgery
• Pregnant or suspect pregnant
• 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
• Subject belonging to other vulnerable population, e.g. prisoner or ward of the state
• Subject is unable to comply with the follow-up visit schedule
• Subject is currently participating in another research study

Sponsors & Collaborators

• Intuitive Surgical: lead

Study Sites (4)

Baptist Health-South Florida

Miami, Florida, 33176, United States

Location

Progressive Surgical Associates, Silver Cross Hospital

New Lenox, Illinois, 60451, United States

Location

Lovelace Medical Group

Albuquerque, New Mexico, 87102, United States

Location

St. David's Healthcare

Austin, Texas, 78701, United States

Location

MeSH Terms

Interventions

Cholecystectomy, Laparoscopic

Intervention Hierarchy (Ancestors)

Cholecystectomy; Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative; Laparoscopy; Endoscopy; Minimally Invasive Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 17, 2021
• Study Start: June 5, 2021
• Primary Completion: January 27, 2025
• Study Completion: January 27, 2025
• Last Updated: May 31, 2025

Record last verified: 2025-01

Locations

US (4)