Safety and Performance of the da Vinci SP® Surgical System in Colorectal Procedures
- Conditions
- Colorectal Neoplasms
- Interventions
- Device: single-port robotic surgery
- Registration Number
- NCT05457244
- Lead Sponsor
- Chang Gung Memorial Hospital
- Brief Summary
The study is a prospective, single-center, single-arm unblinded clinical investigation. The aim of this study is to evaluate the performance and safety of da Vinci SP system. This study will entail a collection of demographics, preoperative, perioperative and postoperative outcomes of the patients into a database to follow this report on the outcomes, and notably answer questions to demonstrate the performance and safety of this surgical option.
All patients being considered for minimally invasive colorectal surgery will be evaluated for participation in the above study. All of these patients will undergo a standard minimally invasive resection in the same fashion as would be carried out with multiport laparoscopic or robotic surgery
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 30
- Age ≥18 years
- Pathological confirm of colon or rectal cancer
- Clinical stage I-III
- Patient is a candidate for minimally invasive right hemicolectomy or anterior resection.
- ASA ≤3
- Performance status: ECOG 0-1
- Emergency surgery
- Patient has metastatic disease
- Patient has a bleeding or clotting disorder
- Uncontrolled illness, including active infection, symptomatic heart failure, unstable angina or cardiac arrhythmias, or psychiatric illness that would limit compliance with study requirements
- Previous laparotomy history
- Patient unable to provide informed consent
- Patient is pregnant
- BMI 35.0 or higher
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Participant arm single-port robotic surgery -
- Primary Outcome Measures
Name Time Method Success rate (%) immediately after the surgery Calculating the percentage of cases successfully performed using the da Vinci SP system via the SP access port with or without an additional 12mm assistant port. Conversion to laparoscopy or laparotomy will be considered as failure.
- Secondary Outcome Measures
Name Time Method Perioperative Parameters:Incision length immediately after the surgery Incision length
Postoperative Parameters:Readmission and reoperation rate Within 30days after the surgery Readmission and reoperation rate
Postoperative Parameters:Time to discharge Within 30days after the surgery Time to discharge
Perioperative Parameters:Time of surgery immediately after the surgery Time of surgery
Perioperative Parameters: Estimated blood loss immediately after the surgery Estimated blood loss
Perioperative Parameters:Robotic console time immediately after the surgery Robotic console time
Perioperative Parameters: Type of anastomosis immediately after the surgery How the anastomosis was performed and method of construction
Postoperative Parameters:pain requirements Within 30days after the surgery type, frequency, total amount of narcotics used postoperatively per day
Postoperative Parameters:Time to tolerate diets Within 30days after the surgery time to tolerate clear liquids and solid food
Postoperative Parameters:Time to flatus Within 30days after the surgery Time to flatus
Perioperative Parameters: Blood transfusions immediately after the surgery Blood transfusion amount
Perioperative Parameters: Intra-operative Complications immediately after the surgery Satava System
Postoperative Parameters:Pain score Within 30days after the surgery NRS
Perioperative Parameters:Total operative time immediately after the surgery Total operative time
Perioperative Parameters: Urine output immediately after the surgery Urine output
Postoperative Parameters:Complications Within 30days after the surgery Clavien-Dindo Classification
Trial Locations
- Locations (1)
Kaohsiung Chang Gung Memorial Hospital
🇨🇳Kaohsiung, Taiwan