Gynecological benign disease
Conditions
Interventions
Domestic laparoscopic single-port surgical system group:None
Sponsors
The Second Affiliated Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Women aged 18 to 75 years old, with a body mass index (BMI) of no more than 32 kg/m^2; 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 understood perioperative care and were 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
Exclusion criteria: 1. Moderate and high-risk patients were 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 cord surgery; 7. Not willing to undergo endoscopic surgery; 8. Participated in other drug and device clinical trials within 3 months before surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| day surgery success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| time of operation;blood loss evaluation;surgeon satisfaction evaluation;time of first postoperative anal exhaust;first spontaneous urination time;pain score;hospital stays;postoperative rehabilitation evaluation;abdominal incision healing;scar satisfaction;discharge assessment;postoperative complication;quality and safety evaluation of day surgery;safety evaluation; | — |
Countries
China
Contacts
Public ContactDuan Ping
The Second Affiliated Hospital of Wenzhou Medical University
Outcome results
None listed