A Clinical Study on the Feasibility and Safety of Abdominal Endoscopic Single-port Surgery System to Assist Gynecological Day Surgery

Second Affiliated Hospital of Wenzhou Medical University

Status: Not yet enrolling

Conditions: Adnexal Diseases; Adnexal Cyst; Uterine Fibroids; Adenopathy; Ovarian Cysts; Adnexal Mass; Ovarian Diseases

Treatments: Device: Domestic single-port laparoscopic surgery system

Study type: Interventional

Funder types: Other

Identifiers

NCT06828419

SAHoWMU-CR2024-07-124

Details and patient eligibility

About

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.

Enrollment: 63 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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63 participants in 1 patient group

Domestic single-port laparoscopic surgery system group

Other group

Description:

The domestic single-port robotic laparoscopic surgery system is a new minimally invasive surgical method. Compared with traditional laparoscopic surgery, it establishes the surgical approach through the natural scar umbilicus of the human body, thus bringing less trauma and beautiful experience to patients

Treatment:

Device: Domestic single-port laparoscopic surgery system