Ankit Sarin,Katherine E Barnes,Amy M Shui,Yukino Nakamura,Daniel B Hoffman,Fernanda Romero-Hernandez,Hueylan Chern
{"title":"单孔机器人右结肠切除术的初步经验:使用新型单孔机器人平台的研究者发起的研究性设备豁免研究结果。","authors":"Ankit Sarin,Katherine E Barnes,Amy M Shui,Yukino Nakamura,Daniel B Hoffman,Fernanda Romero-Hernandez,Hueylan Chern","doi":"10.1097/dcr.0000000000003352","DOIUrl":null,"url":null,"abstract":"BACKGROUND\r\nMinimally invasive surgical techniques have been widely adopted in colorectal surgery. New technological breakthroughs have led to even less invasive alternatives like single-port surgery, but this has been hindered by technical challenges such as the collision of robotic arms within a limited space. The Intuitive da Vinci Single-Port robotic platform is a novel system that overcomes some of these challenges.\r\n\r\nIMPACT OF INNOVATION\r\nThis study aimed to assess the safety and feasibility of the Intuitive da Vinci Single-Port robotic platform in right segmental colectomies among adult patients. These findings may set the stage for more widespread use of single-port robotic surgery.\r\n\r\nTECHNOLOGY, MATERIALS, AND METHODS\r\nThe Intuitive da Vinci Single-Port robot is a system designed specifically for single-port robotic surgery. This platform enables flexible port location and efficient internal and external range of motion using a single C-shaped arm. In the present study, right colectomies were performed in adult patients using this platform between May 2022 and November 2022, and they were compared to right colectomies in adult patients performed using the standard multiport platform between January 2019 and December 2022. The main outcome measure was safety and quality event rates.\r\n\r\nPRELIMINARY RESULTS\r\nOf 30 patients, 16.7% of patients (n = 5) underwent single-port robotic right colectomy and 83.3% (n = 25) underwent multiport right colectomy. In the single-port group, 40% of patients (n = 2) developed a safety/quality event (postoperative portal vein thrombosis and excessive postoperative pain). In the multiport group, 32% of patients (n = 8) developed 1 safety/quality event and 8% (n = 2) had more than 1 event.\r\n\r\nCONCLUSIONS AND FUTURE DIRECTIONS\r\nThis preliminary study, one of the first Food and Drug Administration-approved, investigator-initiated uses of this platform in colorectal surgeries, shows that this platform is a safe and feasible option for right colectomies. On preliminary evaluation, it appears comparable in terms of relevant safety/quality events to the multiport platform.\r\n\r\nCLINICAL TRIAL REGISTRATION\r\nClinicaltrials.gov NCT05321134.","PeriodicalId":11299,"journal":{"name":"Diseases of the Colon & Rectum","volume":null,"pages":null},"PeriodicalIF":3.2000,"publicationDate":"2024-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Initial Experience With Single-Port Robotic Right Colectomies: Results of an Investigator-Initiated Investigational Device Exemption Study Using a Novel Single-Port Robotic Platform.\",\"authors\":\"Ankit Sarin,Katherine E Barnes,Amy M Shui,Yukino Nakamura,Daniel B Hoffman,Fernanda Romero-Hernandez,Hueylan Chern\",\"doi\":\"10.1097/dcr.0000000000003352\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"BACKGROUND\\r\\nMinimally invasive surgical techniques have been widely adopted in colorectal surgery. New technological breakthroughs have led to even less invasive alternatives like single-port surgery, but this has been hindered by technical challenges such as the collision of robotic arms within a limited space. The Intuitive da Vinci Single-Port robotic platform is a novel system that overcomes some of these challenges.\\r\\n\\r\\nIMPACT OF INNOVATION\\r\\nThis study aimed to assess the safety and feasibility of the Intuitive da Vinci Single-Port robotic platform in right segmental colectomies among adult patients. These findings may set the stage for more widespread use of single-port robotic surgery.\\r\\n\\r\\nTECHNOLOGY, MATERIALS, AND METHODS\\r\\nThe Intuitive da Vinci Single-Port robot is a system designed specifically for single-port robotic surgery. This platform enables flexible port location and efficient internal and external range of motion using a single C-shaped arm. In the present study, right colectomies were performed in adult patients using this platform between May 2022 and November 2022, and they were compared to right colectomies in adult patients performed using the standard multiport platform between January 2019 and December 2022. The main outcome measure was safety and quality event rates.\\r\\n\\r\\nPRELIMINARY RESULTS\\r\\nOf 30 patients, 16.7% of patients (n = 5) underwent single-port robotic right colectomy and 83.3% (n = 25) underwent multiport right colectomy. In the single-port group, 40% of patients (n = 2) developed a safety/quality event (postoperative portal vein thrombosis and excessive postoperative pain). In the multiport group, 32% of patients (n = 8) developed 1 safety/quality event and 8% (n = 2) had more than 1 event.\\r\\n\\r\\nCONCLUSIONS AND FUTURE DIRECTIONS\\r\\nThis preliminary study, one of the first Food and Drug Administration-approved, investigator-initiated uses of this platform in colorectal surgeries, shows that this platform is a safe and feasible option for right colectomies. 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Initial Experience With Single-Port Robotic Right Colectomies: Results of an Investigator-Initiated Investigational Device Exemption Study Using a Novel Single-Port Robotic Platform.
BACKGROUND
Minimally invasive surgical techniques have been widely adopted in colorectal surgery. New technological breakthroughs have led to even less invasive alternatives like single-port surgery, but this has been hindered by technical challenges such as the collision of robotic arms within a limited space. The Intuitive da Vinci Single-Port robotic platform is a novel system that overcomes some of these challenges.
IMPACT OF INNOVATION
This study aimed to assess the safety and feasibility of the Intuitive da Vinci Single-Port robotic platform in right segmental colectomies among adult patients. These findings may set the stage for more widespread use of single-port robotic surgery.
TECHNOLOGY, MATERIALS, AND METHODS
The Intuitive da Vinci Single-Port robot is a system designed specifically for single-port robotic surgery. This platform enables flexible port location and efficient internal and external range of motion using a single C-shaped arm. In the present study, right colectomies were performed in adult patients using this platform between May 2022 and November 2022, and they were compared to right colectomies in adult patients performed using the standard multiport platform between January 2019 and December 2022. The main outcome measure was safety and quality event rates.
PRELIMINARY RESULTS
Of 30 patients, 16.7% of patients (n = 5) underwent single-port robotic right colectomy and 83.3% (n = 25) underwent multiport right colectomy. In the single-port group, 40% of patients (n = 2) developed a safety/quality event (postoperative portal vein thrombosis and excessive postoperative pain). In the multiport group, 32% of patients (n = 8) developed 1 safety/quality event and 8% (n = 2) had more than 1 event.
CONCLUSIONS AND FUTURE DIRECTIONS
This preliminary study, one of the first Food and Drug Administration-approved, investigator-initiated uses of this platform in colorectal surgeries, shows that this platform is a safe and feasible option for right colectomies. On preliminary evaluation, it appears comparable in terms of relevant safety/quality events to the multiport platform.
CLINICAL TRIAL REGISTRATION
Clinicaltrials.gov NCT05321134.
期刊介绍:
Diseases of the Colon & Rectum (DCR) is the official journal of the American Society of Colon and Rectal Surgeons (ASCRS) dedicated to advancing the knowledge of intestinal disorders by providing a forum for communication amongst their members. The journal features timely editorials, original contributions and technical notes.