Vnotes surgery using fully visualised surgical instrumentsVnotes surgery using traditional surgical instruments
Vnotes surgery using fully visualised surgical instruments: Vnotes surgery using fully visualised surgical instruments
Vnotes surgery using traditional surgical instruments: Vnotes surgery using traditional surgical instruments
Study summary
The modified vNOTES hysterectomy was accomplished and validated for efficacy and safety using a multi-access vaginal confinement instrument with a fully visualised vaginal access platform.
Eligibility
Sex
FEMALE
Min age
—
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria:
1. Female patients ≤ 60years old
2. Patients requiring total hysterectomy (with or without bilateral adjuncts or salpingectomy) due to uterine fibroids
3. BMI ranges from 18.5 to 27.9kg/m2;
4. Informed consent signed by the subject himself or his legal representative.
Exclusion Criteria:
1. Pregnant and lactating women;
2. asexual life history, vaginal malformations or adhesions, postmenopausal vaginal atrophy and stenosis;
3. Preoperative examination for malignant possibility
4. Uterine volume ≥20 weeks, history of pelvic inflammatory disease, severe endometriosis, degree III or IV uterine prolapse; Previous surgical history of intestinal obstruction, recurrent pelvic inflammatory disease, pelvic tuberculosis, and pelvic abdominal tumor; Gynecological examination of the uterine and rectal fossa is completely closed;
5. Patients known to have severe hepatic or renal dysfunction;
6. Patients with known blood disorders, coagulation disorders, active bleeding at any site, or bleeding propensity;
7. complicated with serious diseases of central nervous system, cardiovascular system, liver and kidney, digestive tract, respiratory system, endocrine and metabolism (thyroid disease, Cushing\'s syndrome, hyperprolactinemia), skeletal and muscular system and mental disorders;
8. patients with acute infection;
9. Known to have participated in any other clinical trial or taken hormone therapy within 3 months;
10. who cannot sign the informed consent;
11. For those with known or suspected poor compliance who could not complete the trial.
Primary outcome measure(s)
Success rate of access platform establishment — End of surgery Success is defined as opening the vaginal vault and entering the abdominal cavity to create stable abdominal pressure
Trial sites (1)
Facility
City
Region
Status
China-Japan Friendship Hospital
Beijing
Beijing Municipality
Recruiting
More China-Japan Friendship Hospital trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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