Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
Location contact
Ping Duan, Master
CONTACT
Ping Duan, Master
PRINCIPAL_INVESTIGATOR
Xingyu Yang, Master
CONTACT
NCT Number: NCT06828419
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.
Trial opening soon.
Get Notified18 year–75 year
Female
Interventional
Not applicable
Wenzhou, Zhejiang, 325000, China
Ping Duan, Master
CONTACT
Ping Duan, Master
PRINCIPAL_INVESTIGATOR
Xingyu Yang, Master
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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。
Time frame: 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.
Time frame: 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。
Time frame: 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.
Time frame: Up to 1 day after surgery
Surgeon satisfaction questionnaire
Time frame: Up to 2 day after surgery
time recording
Time frame: Up to 2 day after surgery
Time recording
Time frame: 4 hours after surgery
Visual Analogue Scale(VAS)
Time frame: From the date of admission to the Date of discharge, assessed up to 2 days
Time
Time frame: Within 1 day after surgery; 24 hours and 30 days after discharge
Quality of Life-15(QOL-15)
Time frame: Within 1 day after surgery
Observation
Time frame: 30 days after discharge
Scar Cosmesis Assessment and Rating(SCAR)
Time frame: Within 1 day after surgery, 4 hours after discharge
Postanesthesia Discharge Score(PADS)
Time frame: 4 hours, 24 hours and 30 days after discharge
Telephone, Wechat official account and outpatient follow-up
Time frame: 30 days after discharge
13 indexes of quality and safety evaluation of day surgery
Time frame: Day of surgery and within 1 day after surgery; 4 hours, 24 hours and 30 days after discharge
6 indexes of safety evaluations
Contact information is provided by the study sponsor or research team.
Ping Duan, Master
CONTACT
Xingyu Yang, Master
CONTACT
Second Affiliated Hospital of Wenzhou Medical University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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