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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ovarian Cysts; Ovarian Diseases; Adnexal Diseases; Uterine Fibroids; Adnexal Mass; Adenopathy; Adnexal Cyst
• Intervention / Treatment: Device: Domestic single-port laparoscopic surgery system

• Study Type: Interventional
• Enrollment (Estimated): 63
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xingyu Yang, Master; Phone Number: +86 173 9805 4822; Email: yangxy_822@163.com
• Study Contact Backup: Name: Ping Duan, Master; Phone Number: +86 135 8743 0406; Email: dppddpp@126.com

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325000
      • Second Affiliated Hospital of Wenzhou Medical University
      • Contact: Xingyu Yang, Master; Phone Number: +86 173 9805 4822; Email: yangxy_822@163.com
      • Contact: Ping Duan, Master; Phone Number: +86 135 8743 0406; Email: dppddpp@126.com
      • Principal Investigator: Ping Duan, Master

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Study Population

Assess whether the subject's disease and basic conditions meet the standards of gynecological day surgery, preliminarily exclude contraindications for surgery, and inform the subject's condition and alternative plans.

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Domestic single-port laparoscopic surgery system group; 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	Device: Domestic single-port laparoscopic surgery system; 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。

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Day Surgery Success Rate	Day surgery success rate means that no other operation is performed during the operation and the patient is discharged within 48 hours.	Patient recruitment ends and all patients complete surgery, up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of Operation	Time of operation includes total operation time, operator teleoperation time, robot system parking time and instrument docking time。	From pre-surgery to the end of surgery，up to 12 hours
Blood Loss Evaluation	The estimated intraoperative blood loss and the difference of hemoglobin before and after operation.	From the time of hemoglobin measurement before surgery to the time of hemoglobin measurement after surgery, up to 1 day after surgery
Surgeon Satisfaction Evaluation	Surgeon satisfaction questionnaire	Up to 1 day after surgery
Time of First Postoperative Anal Exhaust	time recording	Up to 2 day after surgery
First Spontaneous Urination Time	Time recording	Up to 2 day after surgery
Pain Score	Visual Analogue Scale(VAS)	4 hours after surgery
Hospital Stays	Time	From the date of admission to the Date of discharge, assessed up to 2 days
Postoperative Rehabilitation Evaluation	Quality of Life-15(QOL-15)	Within 1 day after surgery; 24 hours and 30 days after discharge
Abdominal Incision Healing	Observation	Within 1 day after surgery
Scar Satisfaction	Scar Cosmesis Assessment and Rating(SCAR)	30 days after discharge
Discharge Assessment	Postanesthesia Discharge Score(PADS)	Within 1 day after surgery, 4 hours after discharge
Postoperative Complication	Telephone, Wechat official account and outpatient follow-up	4 hours, 24 hours and 30 days after discharge
Quality and Safety Evaluation of Day Surgery	13 indexes of quality and safety evaluation of day surgery	30 days after discharge
Safety Evaluation	6 indexes of safety evaluations	Day of surgery and within 1 day after surgery; 4 hours, 24 hours and 30 days after discharge

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): April 10, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 4, 2025
• First Submitted That Met QC Criteria: February 10, 2025
• First Posted (Actual): February 14, 2025

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: March 27, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: day surgery; robotic-assisted laparoscopic single-site surgery (R-LESS); single-port robot system (SPRS)
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Neoplasms; Pathological Conditions, Anatomical; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Genital Diseases, Female; Gonadal Disorders; Lymphatic Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms, Muscle Tissue; Lymphadenopathy; Leiomyoma; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases
• Other Study ID Numbers: SAHoWMU-CR2024-07-124

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No