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Trial Title:
Safety and Efficacy of Using a Novel Full Visual Access Platform System in Transvaginal Hysterectomy
NCT ID:
NCT06658145
Condition:
Uterine Myoma
Surgery, Laparoscopic
Conditions: Official terms:
Leiomyoma
Myofibroma
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Outcomes Assessor)
Intervention:
Intervention type:
Device
Intervention name:
Vnotes surgery using fully visualised surgical instruments
Description:
Vnotes surgery using fully visualised surgical instruments
Arm group label:
Full visibility vnotes group
Intervention type:
Device
Intervention name:
Vnotes surgery using traditional surgical instruments
Description:
Vnotes surgery using traditional surgical instruments
Arm group label:
Traditional vnotes group
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.
Criteria for 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'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.
Gender:
Female
Minimum age:
N/A
Maximum age:
60 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
China-Japan Friendship Hospital
Address:
City:
Beijing
Zip:
086010
Country:
China
Contact:
Last name:
Fang Zhao, MD
Phone:
+86-010-84206115
Email:
jacyliang@sina.com
Start date:
October 2024
Completion date:
June 2027
Lead sponsor:
Agency:
China-Japan Friendship Hospital
Agency class:
Other
Source:
China-Japan Friendship Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06658145
