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

Launched by SECOND AFFILIATED HOSPITAL OF WENZHOU MEDICAL UNIVERSITY · Feb 10, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new surgical method called abdominal endoscopic single-port surgery, which is designed to help treat certain benign gynecological conditions, such as uterine fibroids and ovarian cysts. The study will take place at the Second Affiliated Hospital of Wenzhou Medical University from February 2025 to December 2026 and aims to assess how safe and effective this surgery is for women who need these procedures.

To participate in the trial, women aged 18 to 75, with a body mass index (BMI) of 32 or less, may be eligible if they have no serious health conditions that would complicate the surgery. They should be in good mental health and able to understand the surgery and care required afterward. Participants can expect to receive thorough education about the procedure, including what to expect during and after surgery. It's important to note that not everyone will qualify, as some health issues or previous surgeries may disqualify potential participants. Overall, this study is aimed at improving surgical options for women facing these common health issues.

Gender

FEMALE

Eligibility criteria

• 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.