Safety and Efficacy of Using a Novel Full Visual Access Platform System in Transvaginal Hysterectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeUp to 60
SponsorChina-Japan Friendship Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Female patients ≤ 60years old
Patients requiring total hysterectomy (with or without bilateral adjuncts or salpingectomy) due to uterine fibroids
BMI ranges from 18.5 to 27.9kg/m2;
Informed consent signed by the subject himself or his legal representative.
Disqualifiers
Pregnant and lactating women;
asexual life history, vaginal malformations or adhesions, postmenopausal vaginal atrophy and stenosis;
Preoperative examination for malignant possibility
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Vnotes surgery using fully visualised surgical instruments
DeviceVnotes surgery using fully visualised surgical instruments
Vnotes surgery using traditional surgical instruments
DeviceVnotes surgery using traditional surgical instruments
Treatment groups
94 Participants
are divided into 2 treatment groupsGroup A: Full visibility vnotes groupExperimental treatment 1 intervention
Group B: Traditional vnotes groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Success rate of access platform establishment
Success is defined as opening the vaginal vault and entering the abdominal cavity to create stable abdominal pressure
Time frame
End of surgerySecondary outcomes
1
Tightness of equipment
Throughout the operation, whether the device can remain airtight
Time frame
End of surgery2
Stability of equipment
Throughout the operation, whether the equipment is tilted or slipped
Time frame
End of surgery3
Controllability of equipment
Throughout the operation, whether the equipment can be smoothly inserted, extended, conformed, and advanced
Time frame
End of surgery4
Time of establishment of the access platform
The time from the start of the procedure to the establishment of vaginal access
Time frame
End of surgerySponsors and contacts
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Source ClinicalTrials.gov