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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
| Yale University | OTHER |
| Henry Ford Hospital | OTHER |
| University of Massachusetts, Worcester |
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Currently a multiport robotic surgery platform (Intuitive Xi) is widely available and used for colorectal surgery indications. A Single port platform (Intuitive SP) is FDA approved for Head and Neck and Urology but has not been widely used in colorectal surgery. This study seeks to evaluate the safe and effective use of the SP platform for colorectal surgery indications.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Port Robotic Surgery Arm | Experimental | Study subjects will undergo the colorectal surgical procedure (determined based on routine standard clinical care) using the Intuitive Da Vinci Single Port SP system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single port robotic colorectal surgical procedure | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Assess safety & quality event rate for SP platform transabdominal and transanal colorectal operations | A safety & quality event will be defined as occurring if any of the following occur:
| 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ankit Sarin, MD | Contact | 9167034472 | axsarin@ucdavis.edu | |
| Pallavi Vaidya, BPharm | Contact | 9167346609 | pmvaidya@ucdavis.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ankit Sarin, MD | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis Medical Center | Recruiting | Sacramento | California | 95817 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39250792 | Derived | Sarin A, Barnes KE, Shui AM, Nakamura Y, Hoffman DB, Romero-Hernandez F, Chern H. Initial Experience With Single-Port Robotic Right Colectomies: Results of an Investigator-Initiated Investigational Device Exemption Study Using a Novel Single-Port Robotic Platform. Dis Colon Rectum. 2024 Oct 1;67(10):e1600-e1606. doi: 10.1097/DCR.0000000000003352. Epub 2024 Sep 5. |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D012005 | Rectal Prolapse |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| OTHER |
Single center, prospective, open-label, investigator initiated, non-randomized, interventional case-control study
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D056887 | Pelvic Organ Prolapse |
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |