A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Colorectal Surgeries（SPiM-RWS-CR）
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| RWS study for SP CR Surgeries da Vinci SP Surgical System(SP1098)
|
Procedure: procedure
procedure
|
Outcome Measures
Primary Outcome Measures
- 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]
Secondary Outcome Measures
- Intraoperative bleeding volume [Intraoperative]
- The rate of intraoperative blood transfusion [Intraoperative]
- Surgical duration [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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
-
Patients who voluntarily decide to participate in the study and sign the ICF (or exempt from signature of the ICF as approved by the EC).
Exclusion Criteria:
-
Patients with missing data on the primary endpoint in retrospective cases;
-
Subjects having any contraindications of single-port robot surgery;
-
The intraoperative anatomy determined that minimally invasive surgery was not suitable;
-
Patients who are considered inappropriate to participate in this study by investigator.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ruijin Hospital | Shanghai | Shanghai | China | 200025 |
Sponsors and Collaborators
- Ruijin Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ISFMT-SP-003