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

Laparoscopic Cholecystectomy Clinical Trial

Official title:

COMPlex Cholecystectomy Trial (COMPaCT): A Prospective Multi-Center Study of Short-Term Outcomes After Complex Cholecystectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04888117
• Other study ID #: COMPaCT
• Status: Recruiting
• Start date: June 5, 2021
• Est. completion date: December 2024

Study information

• Verified date: May 2023
• Source: Intuitive Surgical
• Contact: Alison Gorski
• Phone: 408-523-1855
• Email: Alison.Gorski[@]intusurg.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Laparoscopic Cholecystectomy

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Lovelace Medical Group	Albuquerque	New Mexico
United States	St. David's Healthcare	Austin	Texas
United States	Baptist Health-South Florida	Miami	Florida
United States	Progressive Surgical Associates, Silver Cross Hospital	New Lenox	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Intuitive Surgical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conversion to open	The rate of conversion of the cholecystectomy to open, defined as robotic-assisted surgery converted to an open approach	Intra-operative
Primary	Number of adverse events	Intra-operative or post-operative adverse events related to the cholecystectomy	Intra-operative through the 30 days follow-up period
Primary	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
Primary	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	Operative time	Operative time, defined as first incision to closure of the incision	Intra-operative
Secondary	Use of intra-operative imaging	The rate of intra-operative imaging, including indocyanine green fluorescent imaging and cholangiography	Intra-operative
Secondary	Length of hospital stay	How long the patient was admitted to the hospital	From admission to discharge, up to approximately one week
Secondary	Biliary anatomy identification	Ability for surgeons to identify biliary anatomy and incidence of abnormal biliary anatomy intra-operatively	Intra-operative
Secondary	Change in pain score assessed by the PROMIS 3a from baseline to 14 days	Change in patient reported pain scores assessed by the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity 3a survey, with a scale from 1-5; 1 meaning no pain and 5 meaning severe pain	14 days
Secondary	Change in pain score assessed by the PROMIS 3a from baseline to 30 days	Change in patient reported pain scores assessed by the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity 3a survey, with a scale from 1-5; 1 meaning no pain and 5 meaning severe pain	30 days
Secondary	Change in Quality of Life assessment: EQ-5D-5L (EQ) from baseline to 14 days	Quality of life using the EQ-5D-5L (EQ) assessment tool, with scores on individual questions ranging from no problems to extreme problems, with a scale of health ranging from 0 (the worst health you can imagine) to 100 (the best health you can imagine)	14 days
Secondary	Change in Quality of Life assessment: EQ-5D-5L (EQ) from baseline to 30 days	Quality of life using the EQ-5D-5L (EQ) assessment tool, with scores on individual questions ranging from no problems to extreme problems, with a scale of health ranging from 0 (the worst health you can imagine) to 100 (the best health you can imagine)	30 days