A Clinical Study on the Feasibility and Safety of Abdominal Endoscopic Single-port Surgery System… (NCT06828419) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Clinical Study on the Feasibility and Safety of Abdominal Endoscopic Single-port Surgery System to Assist Gynecological Day Surgery
China63 participantsStarted 2025-04-10
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexFEMALE
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Inclusion criteria
✓. 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;
✓. Elective surgery, no serious complications affecting the operation and prognosis, aCCI age adjusted comorbidity index 0 points;
✓. 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
✕. Moderate and high-risk patients will be excluded based on ANGEL adhesion risk scoring system;
What they're measuring
1
Day Surgery Success Rate
Timeframe: Patient recruitment ends and all patients complete surgery, up to 2 years
Trial details
NCT IDNCT06828419
SponsorSecond Affiliated Hospital of Wenzhou Medical University