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

Recruiting

• Conditions: Laparoscopic Cholecystectomy; Robotic-assisted Cholecystectomy
• Interventions: Procedure: Laparoscopic cholecystectomy; Procedure: Robotic-assisted cholecystectomy

• Registration Number: NCT04888117
• Lead Sponsor: Intuitive Surgical

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2021-05-11
• Study First Submitted QC: 2021-05-11
• Study First Posted: 2021-05-17
• Study Start: 2021-06-05
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-26
• Last Update Posted: 2023-05-31
• Primary Completion: 2024-08
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Laparoscopic cholecystectomy	Laparoscopic cholecystectomy	Subject has a diagnosis of acute cholecystitis and is admitted through the ER for a laparoscopic cholecystectomy.
Robotic-assisted cholecystectomy	Robotic-assisted cholecystectomy	Subject has a diagnosis of acute cholecystitis and is admitted through the ER for a robotic-assisted cholecystectomy.

Primary Outcome Measures

Name	Time	Method
Number of adverse events	Intra-operative through the 30 days follow-up period	Intra-operative or post-operative adverse events related to the cholecystectomy
Conversion to open	Intra-operative	The rate of conversion of the cholecystectomy to open, defined as robotic-assisted surgery converted to an open approach
Re-admissions	After discharge from the hospital post-procedure through the 30 days follow-up period	Re-admissions to the hospital related to the cholecystectomy through the 30 days follow-up period
Re-operations	After the procedure but prior to discharge, through the 30 day follow-up period	Re-operations related to the cholecystectomy through 30 days follow-up

Secondary Outcome Measures

Name	Time	Method
Operative time	Intra-operative	Operative time, defined as first incision to closure of the incision
Length of hospital stay	From admission to discharge, up to approximately one week	How long the patient was admitted to the hospital
Use of intra-operative imaging	Intra-operative	The rate of intra-operative imaging, including indocyanine green fluorescent imaging and cholangiography
Change in pain score assessed by the PROMIS 3a from baseline to 14 days	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
Change in pain score assessed by the PROMIS 3a from baseline to 30 days	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
Biliary anatomy identification	Intra-operative	Ability for surgeons to identify biliary anatomy and incidence of abnormal biliary anatomy intra-operatively
Change in Quality of Life assessment: EQ-5D-5L (EQ) from baseline to 30 days	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)
Change in Quality of Life assessment: EQ-5D-5L (EQ) from baseline to 14 days	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)

Trial Locations

Locations (4)

Progressive Surgical Associates, Silver Cross Hospital; 🇺🇸 New Lenox, Illinois, United States

St. David's Healthcare; 🇺🇸 Austin, Texas, United States

Lovelace Medical Group; 🇺🇸 Albuquerque, New Mexico, United States

Baptist Health-South Florida; 🇺🇸 Miami, Florida, United States