About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women aged 18 to 75 years old, with a body mass index (BMI) of no more than 32 kg/m2;
Conscious, no history of mental illness, accompanied by an adult during the perioperative period;
Educate the subjects, who are willing to undergo day surgery, understand and accept the surgical method and anesthesia method;
Subjects and families understand perioperative care and are willing and able to complete post-discharge care;
Disqualifiers
Moderate and high-risk patients will be excluded based on ANGEL adhesion risk scoring system;
Subjects with hemorrhagic rupture of ectopic pregnancy and unstable vital signs;
Genital tract infection or in the acute phase of systemic infection;
Subjects on long-term anticoagulant therapy or with coagulation dysfunction;
Trial design
Single group
Treatments tested in this trial
Domestic single-port laparoscopic surgery system
DeviceThe 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。
Treatment groups
Trial outcomes
Primary outcomes
Day Surgery Success Rate
Day surgery success rate means that no other operation is performed during the operation and the patient is discharged within 48 hours.
Secondary outcomes
Time of Operation
Time of operation includes total operation time, operator teleoperation time, robot system parking time and instrument docking time。
Blood Loss Evaluation
The estimated intraoperative blood loss and the difference of hemoglobin before and after operation.
Surgeon Satisfaction Evaluation
Surgeon satisfaction questionnaire
Time of First Postoperative Anal Exhaust
time recording
Sponsors and contacts
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