Evaluation of SINGLE PORT (SP) Robotic Technology in Colorectal Surgery
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|ClinicalTrials.gov Identifier: NCT05321134|
Recruitment Status : Recruiting
First Posted : April 11, 2022
Last Update Posted : May 24, 2022
|Condition or disease||Intervention/treatment||Phase|
|Colo-rectal Cancer Rectal Prolapse Colostomy Stoma Colorectal Disorders||Device: Single port robotic colorectal surgical procedure||Not Applicable|
This is a single center, prospective, open-label, investigator initiated, non-randomized, interventional case-control study where researchers will study colorectal surgical procedures done using the novel Single Port (SP) Robotic Platform and compare perioperative outcomes to colorectal surgical cases done using the traditional Multi-port (Xi) Robotic Platform.
AIM 1 To assess the feasibility and safety/quality of a SP platform for transabdominal and transanal colorectal operations which are currently done using multiport robotic platforms.
AIM 2 To evaluate safety and quality outcomes post SP surgery in comparison with contemporaneous standard multiport Xi platform procedures.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single center, prospective, open-label, investigator initiated, non-randomized, interventional case-control study|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of SINGLE PORT (SP) Robotic Technology in Colorectal Surgery|
|Actual Study Start Date :||April 28, 2022|
|Estimated Primary Completion Date :||April 2023|
|Estimated Study Completion Date :||April 2028|
Experimental: Single Port Robotic Surgery Arm
Study subjects will undergo the colorectal surgical procedure (determined based on routine standard clinical care) using the Intuitive Da Vinci Single Port SP system
Device: Single port robotic colorectal surgical procedure
After screening and counseling, study subjects who wish to participate will undergo the colorectal surgical procedure (determined based on routine standard clinical care) using the alternate Intuitive Da Vinci Single Port SP system rather than the currently used multiport system, (Intuitive Da Vinci Multiport Xi System).
Using standardized case report forms, the investigators will track clinical parameters and describe the safety & quality event rate for SP platform transabdominal and transanal colorectal operations.
- Assess safety & quality event rate for SP platform transabdominal and transanal colorectal operations [ Time Frame: 30 days ]
A safety & quality event will be defined as occurring if any of the following occur:
- Conversion to open or laparoscopic procedure
- EBL > 200 ml, or
- Operative time > 90th percentile of all procedures with matching CPT code, or
- Positive pathological margins (if applicable), or
- Fragmented specimen (if applicable) or
- Unplanned ICU stay or
- Post-procedure LOS > 90th percentile of all procedures with matching CPT code, or
- Reoperation within 30 days or
- Post Procedure Pain > 90th percentile (visual analog score)
- Postoperative complication as defined by NSQIP (including SSI, DVT, PE, readmission, anastomotic Leak (if applicable)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05321134
|Contact: Ankit Sarin, MDemail@example.com|
|Contact: Hueylan Chern, MD||4158853625||Hueylan.Chern@ucsf.edu|
|United States, California|
|UCSF Medical Center at Mission Bay||Recruiting|
|San Francisco, California, United States, 94158|
|Contact: Ankit Sarin, MD|
|Principal Investigator:||Ankit Sarin, MD||University of California, San Francisco|