Evaluating a new surgical platform for hysterectomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial assesses the safety and efficacy of a novel full visual access platform system in performing transvaginal hysterectomies for patients with uterine fibroids. It is a multi-center, prospective randomized controlled trial where participants are assigned to either the experimental vNOTES group or the traditional laparoscopic group. Key metrics such as surgical time, bleeding, anesthesia indicators, and complications are recorded to evaluate the effectiveness of the new technique compared to traditional methods.

Why it matters

Who can join: the full rules

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.

Where it's running

• China-Japan Friendship Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Jing Liang, MD — China-Japan Friendship Hospital
• Study coordinator: Jing Liang, MD
• Email: jacyliang@sina.com
• Phone: 8684206115

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.