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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06828419
• Lead Sponsor: Second Affiliated Hospital of Wenzhou Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-04
• Study First Submitted QC: 2025-02-10
• Status Verified: 2025-03
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-04-03
• Study Start: 2025-04-10
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 63

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Day Surgery Success Rate	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.

Secondary Outcome Measures

Name	Time	Method
Time of Operation	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。
Blood Loss Evaluation	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.
Surgeon Satisfaction Evaluation	Up to 1 day after surgery	Surgeon satisfaction questionnaire
Time of First Postoperative Anal Exhaust	Up to 2 day after surgery	time recording
First Spontaneous Urination Time	Up to 2 day after surgery	Time recording
Pain Score	4 hours after surgery	Visual Analogue Scale(VAS)
Hospital Stays	From the date of admission to the Date of discharge, assessed up to 2 days	Time
Postoperative Rehabilitation Evaluation	Within 1 day after surgery; 24 hours and 30 days after discharge	Quality of Life-15(QOL-15)
Abdominal Incision Healing	Within 1 day after surgery	Observation
Scar Satisfaction	30 days after discharge	Scar Cosmesis Assessment and Rating(SCAR)
Discharge Assessment	Within 1 day after surgery, 4 hours after discharge	Postanesthesia Discharge Score(PADS)
Postoperative Complication	4 hours, 24 hours and 30 days after discharge	Telephone, Wechat official account and outpatient follow-up
Quality and Safety Evaluation of Day Surgery	30 days after discharge	13 indexes of quality and safety evaluation of day surgery
Safety Evaluation	Day of surgery and within 1 day after surgery; 4 hours, 24 hours and 30 days after discharge	6 indexes of safety evaluations

Trial Locations

Locations (1)

Second Affiliated Hospital of Wenzhou Medical University; 🇨🇳 Wenzhou, Zhejiang, China