Clinical trial NCT06082011: A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Gynecological Surgeries(SPiM-RWS-GYN)
Official title: A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Gynecological Surgeries
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gynecological Surgeries
Keywords: radical hysterectomy
salpingectomy/oophorectomy
vaginal hysterectomy
total hysterectomy
myomectomy
ovarian cystectomy
deep endometriosis resection
pelvic and abdominal lymphadenectomy
sentinel lymph node resection by image development
uterus/vagino-sacral colpopexy
high uterosacral ligament suspension
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2023-10-13
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 single-port gynecological surgeries with the SP single-port robot such as radical hysterectomy, salpingectomy/oophorectomy, vaginal hysterectomy, total hysterectomy, myomectomy, ovarian cystectomy, deep endometriosis resection, pelvic and abdominal lymphadenectomy, sentinel lymph node resection by image development, uterus/vagino-sacral colpopexy, and high uterosacral ligament suspension.

Brief summary: Study name：A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Gynecological Surgeries Study purpose：This clinical trial is 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 robotic surgeries of gynecological benign and malignant tumors in the real world, providing a real world evidence for clinical application of the product in the Chinese population.

Study design：Retrospective + prospective, real-world study

English name: da Vinci SP Surgical System Model and specification: SP1098 Manufacturer: Intuitive Surgical, Inc.


Eligibility criteria: Inclusion Criteria:

1. Female patients who have received or plan to receive gynecological surgeries with the SP single-port robot such as radical hysterectomy, salpingectomy/oophorectomy, vaginal hysterectomy, total hysterectomy, myomectomy, ovarian cystectomy, deep endometriosis resection, pelvic and abdominal lymphadenectomy, sentinel lymph node resection by image development, uterus/vagino-sacral colpopexy, and high uterosacral ligament suspension.
2. Patients who voluntarily 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. Patients having any contraindications of single-port robot surgery;
3. The intraoperative anatomy demonstrate that minimally invasive surgery is not suitable;
4. Patients who are considered inappropriate to participate in this Study by investigators.

Primary outcomes:
measure: Primary efficacy endpoint: Intraoperative conversion rate
timeFrame: Intraoperative
measure: Primary safety endpoint: Incidence of device related or possibly related complications meeting the Clavien-Dindo Grading System level 3 or above criteria within 30 days after the surgery
timeFrame: 30 days
Secondary outcomes:
measure: Intraoperative bleeding volume
timeFrame: Intraoperative
measure: Intraoperative blood transfusion rate
timeFrame: Intraoperative
measure: Surgical duration
timeFrame: Intraoperative
measure: Length of stay (LOS)
timeFrame: During the follow-up 1 day before discharge.The LOS is defined as the total inpatient days of each subject from the day of the surgery to the day of discharge (unit: days).
measure: Admission to ICU and ICU LOS
timeFrame: During the follow-up 1 day before discharge, the admission to ICU and ICU LOS (unit: days) of each subject should be recorded.
measure: Postoperative pain score
timeFrame: during the follow-ups 1 day (24±4 h), 3 days (72±4 h) and 1 month (30±5 days) after the surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai JiaoTong University School of Medicine affliated Ruijin Hospital
state: Shanghai
Study officials:
References: