Clinical trial NCT06658145: Safety and Efficacy of Using a Novel Full Visual Access Platform System in Transvaginal Hysterectomy
Official title: The Establishment and Clinical Study of the Whole Visual VNOTES Approach Platform
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Uterine Myoma
Surgery, Laparoscopic
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2024-10-26
Enrollment: 94
Sex: FEMALE
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: A multi-center prospective randomized controlled trial was conducted to evaluate the efficacy and safety of the vNOTES technique in patients with uterine fibroids who were scheduled for total hysterectomy. The patients were randomly assigned to the vNOTES group (experimental group) and the traditional vNOTES group (control group). The access platform was established using a visualization method or the traditional laparoscopic method, and the surgical operation was completed. The time required to establish the platform, the amount of bleeding, the total surgical time, the anesthesia indicators, complications, and follow-up indicators were recorded, and the effectiveness and safety of the technique were evaluated.

Eligibility criteria: 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\&#39;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 outcomes:
measure: Success rate of access platform establishment
timeFrame: End of surgery
Secondary outcomes:
measure: Tightness of equipment
timeFrame: End of surgery
measure: Stability of equipment
timeFrame: End of surgery
measure: Controllability of equipment
timeFrame: End of surgery
measure: Time of establishment of the access platform
timeFrame: End of surgery
measure: Total time of surgery
timeFrame: End of surgery
measure: Total surgical bleeding volume
timeFrame: End of surgery
measure: The amount of bleeding during the process of establishing the platform
timeFrame: End of surgery
measure: Surgical complications
timeFrame: 6 months after surgery
measure: Length of hospital stay
timeFrame: 6 months after surgery
measure: Pain VAS score
timeFrame: 6 months after surgery
measure: The Patients' life quality postoperative
timeFrame: 6 months after surgery
measure: Heart rate during surgery
timeFrame: End of surgery
measure: blood pressure during surgery
timeFrame: End of surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
Study officials:
affiliation: China-Japan Friendship Hospital
name: Jing Liang, MD
role: PRINCIPAL_INVESTIGATOR
References: