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
Qualifiers
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
Treatments tested in this trial
- Vnotes surgery using fully visualised surgical instruments
- Vnotes surgery using traditional surgical instruments
Treatment groups
94 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov