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

N/ANot Yet RecruitingNCT06828419

Second Affiliated Hospital of Wenzhou Medical University63 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Adenopathy Uterine Fibroids Ovarian Cysts Adnexal Mass Ovarian Diseases

Interventions

Domestic single-port laparoscopic surgery systemDEVICE

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。

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Patient recruitment ends and all patients complete surgery, up to 2 years

Secondary Outcomes

Time of Operation

Time of operation includes total operation time, operator teleoperation time, robot system parking time and instrument docking time。

Time frame: 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.

Time frame: 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

Time frame: Up to 1 day after surgery

Time of First Postoperative Anal Exhaust

time recording

Time frame: Up to 2 day after surgery

First Spontaneous Urination Time

Time recording

Time frame: Up to 2 day after surgery

Pain Score

Visual Analogue Scale(VAS)

Time frame: 4 hours after surgery

Hospital Stays

Time

Time frame: From the date of admission to the Date of discharge, assessed up to 2 days

Postoperative Rehabilitation Evaluation

Quality of Life-15(QOL-15)

Time frame: Within 1 day after surgery; 24 hours and 30 days after discharge

Abdominal Incision Healing

Observation

Time frame: Within 1 day after surgery

Scar Satisfaction

Scar Cosmesis Assessment and Rating(SCAR)

Time frame: 30 days after discharge

Discharge Assessment

Postanesthesia Discharge Score(PADS)

Time frame: Within 1 day after surgery, 4 hours after discharge

Postoperative Complication

Telephone, Wechat official account and outpatient follow-up

Time frame: 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

Time frame: 30 days after discharge

Safety Evaluation

6 indexes of safety evaluations

Time frame: Day of surgery and within 1 day after surgery; 4 hours, 24 hours and 30 days after discharge