Clinical trial NCT06141421: 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）
Official title: A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Colorectal Surgeries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Single-Port Colorectal Surgeries
Keywords: Single-Port Colorectal Surgeries
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
transanal minimally invasive surgery
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2023-11-21
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: Inclusion Criteria:

1. 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.
2. 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:

1. Patients with missing data on the primary endpoint in retrospective cases;
2. Subjects having any contraindications of single-port robot surgery;
3. The intraoperative anatomy determined that minimally invasive surgery was not suitable;
4. Patients who are considered inappropriate to participate in this study by investigator.

Primary outcomes:
measure: Intraoperative conversion rate
timeFrame: Intraoperative
measure: The incidence of device-related or likely related complications of Clavien-Dindo classification grade III or higher at postoperative 30 days
timeFrame: 30 days
Secondary outcomes:
measure: Intraoperative bleeding volume
timeFrame: Intraoperative
measure: The rate of intraoperative blood transfusion
timeFrame: Intraoperative
measure: Surgical duration
timeFrame: Intraoperative
measure: Length of stay (LOS)
timeFrame: During the follow-up 1 day before discharge
measure: Admission to ICU and ICU LOS
timeFrame: During the follow-up 1 day before discharge
measure: Urethral catheter indwelling duration
timeFrame: in the follow-up 1 month after the surgery
measure: Postoperative pain score
timeFrame: follow-ups 1 day (24±4 h), 3 days (72±4 h) and 1 month (30±5 days) after the surgery.
measure: Short-term recovery of functions
timeFrame: in the follow-up 1 month after the surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
state: Shanghai
Study officials:
References: