Clinical trial NCT06828419: A Clinical Study on the Feasibility and Safety of Abdominal Endoscopic Single-port Surgery System to Assist Gynecological Day Surgery
Official title: A Clinical Study on the Feasibility and Safety of Abdominal Endoscopic Single-port Surgery System to Assist Gynecological Day Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Adenopathy
Uterine Fibroids
Ovarian Cysts
Adnexal Mass
Ovarian Diseases
Adnexal Cyst
Adnexal Diseases
Keywords: robotic-assisted laparoscopic single-site surgery (R-LESS)
single-port robot system (SPRS)
day surgery
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 63
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Day Surgery Success Rate
timeFrame: Patient recruitment ends and all patients complete surgery, up to 2 years
Secondary outcomes:
measure: Time of Operation
timeFrame: From pre-surgery to the end of surgery，up to 12 hours
measure: Blood Loss Evaluation
timeFrame: From the time of hemoglobin measurement before surgery to the time of hemoglobin measurement after surgery, up to 1 day after surgery
measure: Surgeon Satisfaction Evaluation
timeFrame: Up to 1 day after surgery
measure: Time of First Postoperative Anal Exhaust
timeFrame: Up to 2 day after surgery
measure: First Spontaneous Urination Time
timeFrame: Up to 2 day after surgery
measure: Pain Score
timeFrame: 4 hours after surgery
measure: Hospital Stays
timeFrame: From the date of admission to the Date of discharge, assessed up to 2 days
measure: Postoperative Rehabilitation Evaluation
timeFrame: Within 1 day after surgery; 24 hours and 30 days after discharge
measure: Abdominal Incision Healing
timeFrame: Within 1 day after surgery
measure: Scar Satisfaction
timeFrame: 30 days after discharge
measure: Discharge Assessment
timeFrame: Within 1 day after surgery, 4 hours after discharge
measure: Postoperative Complication
timeFrame: 4 hours, 24 hours and 30 days after discharge
measure: Quality and Safety Evaluation of Day Surgery
timeFrame: 30 days after discharge
measure: Safety Evaluation
timeFrame: Day of surgery and within 1 day after surgery; 4 hours, 24 hours and 30 days after discharge
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Second Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
References: