Safety and Efficacy of Using a Novel Full Visual Access Platform System in Transvaginal Hysterectomy

Launched by CHINA-JAPAN FRIENDSHIP HOSPITAL · Oct 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new method for performing a surgery called a hysterectomy, which is the removal of the uterus. The focus is on a technique that allows doctors to see everything clearly while doing the surgery through the vaginal area, using a special tool. This method aims to make the surgery safer and more effective for women who have uterine fibroids, which are growths in the uterus that can cause various health issues.

To be eligible for this trial, participants must be women aged 60 or younger who need a total hysterectomy due to uterine fibroids. They should have a body mass index (BMI) between 18.5 and 27.9, and they must be able to give their consent to participate. However, women who are pregnant, have certain health conditions, or have had specific surgeries in the past may not qualify. Participants in the trial can expect to undergo the new surgical procedure and will be monitored for their safety and the effectiveness of the technique. This trial is currently recruiting participants, and it's an opportunity to help advance the treatment options for women facing these health challenges.

Gender

FEMALE

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.