Adenopathy, Adnexal Cyst, Adnexal Diseases, Adnexal Mass, Ovarian Cysts, Ovarian Diseases, Uterine Fibroids
Conditions
Keywords
robotic-assisted laparoscopic single-site surgery (R-LESS), single-port robot system (SPRS), day surgery
Brief summary
In this study, a prospective study is used to select patients who will undergo intra-abdominal endoscopic single-port surgery system for benign gynecological diseases from February 2025 to December 2026 in the Second Affiliated Hospital of Wenzhou Medical University, including hysterectomy, myomectomy, ovarian cyst removal and adnexectomy. The study will perform statistical analysis to evaluate the feasibility and the main factors affecting the safety of intra-abdominal endoscopic single-port surgery system(SR-ENS-600) used in gynecological day surgery.
Interventions
DEVICEDomestic single-port laparoscopic surgery system
The minimum distance of the single-port surgical system from the port is 5-7cm to obtain the instrument bending space. The load capacity of surgical tools is increased from 2N to 5N, which greatly improves the structural reliability. At the same time, it can realize 6 degrees of freedom movement。
Sponsors
Second Affiliated Hospital of Wenzhou Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Women aged 18 to 75 years old, with a body mass index (BMI) of no more than 32 kg/m2; 2. Conscious, no history of mental illness, accompanied by an adult during the perioperative period; 3. Educate the subjects, who are willing to undergo day surgery, understand and accept the surgical method and anesthesia method; 4. Subjects and families understand perioperative care and are willing and able to complete post-discharge care; 5. Elective surgery, no serious complications affecting the operation and prognosis, aCCI age adjusted comorbidity index 0 points; 6. According to the adhesion risk scoring system of European Anti-Adhesions in Gynaecology Expert Panel (ANGEL), the adhesion risk was divided into three levels: high, medium and low. Subjects with low risk (0 to 12 points) and abdominal wall scarring and pelvic cavity B-ultrasonography do not indicate obvious pelvic cavity adhesion wiil be included.
Exclusion criteria
1. Moderate and high-risk patients will be excluded based on ANGEL adhesion risk scoring system; 2. Subjects with hemorrhagic rupture of ectopic pregnancy and unstable vital signs; 3. Genital tract infection or in the acute phase of systemic infection; 4. Subjects on long-term anticoagulant therapy or with coagulation dysfunction; 5. Subjects have severe heart and lung disease, liver and kidney dysfunction, and cannot tolerate anesthesia; 6. A history of abdominal or diaphragmatic hernia, abnormal umbilical cord development, or umbilical surgery; 7. Not willing to undergo endoscopic surgery; 8. Participated in other drug and device clinical trials within 3 months before surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Day Surgery Success Rate | Patient recruitment ends and all patients complete surgery, up to 2 years | Day surgery success rate means that no other operation is performed during the operation and the patient is discharged within 48 hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Loss Evaluation | From the time of hemoglobin measurement before surgery to the time of hemoglobin measurement after surgery, up to 1 day after surgery | The estimated intraoperative blood loss and the difference of hemoglobin before and after operation. |
| Surgeon Satisfaction Evaluation | Up to 1 day after surgery | Surgeon satisfaction questionnaire |
| Time of First Postoperative Anal Exhaust | Up to 2 day after surgery | time recording |
| First Spontaneous Urination Time | Up to 2 day after surgery | Time recording |
| Pain Score | 4 hours after surgery | Visual Analogue Scale(VAS) |
| Hospital Stays | From the date of admission to the Date of discharge, assessed up to 2 days | Time |
| Time of Operation | From pre-surgery to the end of surgery，up to 12 hours | Time of operation includes total operation time, operator teleoperation time, robot system parking time and instrument docking time。 |
| Abdominal Incision Healing | Within 1 day after surgery | Observation |
| Scar Satisfaction | 30 days after discharge | Scar Cosmesis Assessment and Rating(SCAR) |
| Discharge Assessment | Within 1 day after surgery, 4 hours after discharge | Postanesthesia Discharge Score(PADS) |
| Postoperative Complication | 4 hours, 24 hours and 30 days after discharge | Telephone, Wechat official account and outpatient follow-up |
| Quality and Safety Evaluation of Day Surgery | 30 days after discharge | 13 indexes of quality and safety evaluation of day surgery |
| Safety Evaluation | Day of surgery and within 1 day after surgery; 4 hours, 24 hours and 30 days after discharge | 6 indexes of safety evaluations |
| Postoperative Rehabilitation Evaluation | Within 1 day after surgery; 24 hours and 30 days after discharge | Quality of Life-15(QOL-15) |
Countries
China
Contacts
Primary ContactXingyu Yang, Master
Backup ContactPing Duan, Master
Outcome results
None listed