Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A real-world study to evaluate the clinical performance and safety of da Vinci SP Surgical System ("SP single-port robot" for short) for single-port robot-assisted colorectal surgeries in the real world, providing a real world evidence for clinical application of the product in the Chinese population.
English name: da Vinci SP Surgical System Model and specification: SP1098 Manufacturer: Intuitive Surgical, Inc.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RWS study for SP CR Surgeries da Vinci SP Surgical System(SP1098) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| procedure | Procedure | procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative conversion rate | Intraoperative | |
| The incidence of device-related or likely related complications of Clavien-Dindo classification grade III or higher at postoperative 30 days | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative bleeding volume | Intraoperative | |
| The rate of intraoperative blood transfusion | Intraoperative | |
| Surgical duration |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Subjects who have received or plan to receive colorectal surgeries with the SP single-port robot, such as low anterior resection of the rectum with or without total mesorectal excision; right hemicolectomy, left hemicolectomy and sigmoidectomy with or without transanal total mesocolic excision and central blood vessel ligation; and transanal minimally invasive surgery.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital | Shanghai | Shanghai Municipality | 200025 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41247915 | Derived | Huang C, Shi Y, Song Z, Gong X, Jiang Y, Liu K, Zhang T, Zhao R. Single-port robotic-assisted colorectal surgery using the da Vinci SP system: a preliminary noncomparative exploratory cohort study. Int J Surg. 2026 Feb 1;112(2):3451-3456. doi: 10.1097/JS9.0000000000003915. Epub 2025 Nov 13. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
| Intraoperative |
| Length of stay (LOS) | During the follow-up 1 day before discharge |
| Admission to ICU and ICU LOS | During the follow-up 1 day before discharge |
| Urethral catheter indwelling duration | in the follow-up 1 month after the surgery |
| Postoperative pain score | follow-ups 1 day (24±4 h), 3 days (72±4 h) and 1 month (30±5 days) after the surgery. |
| Short-term recovery of functions | in the follow-up 1 month after the surgery |