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

NCT06658145 | Recruiting DMC

• 1 other identifier: NTCS-vnotesLH
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Uterine Myoma; Surgery, Laparoscopic

Outcome Measures

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

  End of surgery

Secondary Outcomes (13)

• Tightness of equipment

  End of surgery

• Stability of equipment

  End of surgery

• Controllability of equipment

  End of surgery

• Time of establishment of the access platform

  End of surgery

• Total time of surgery

  End of surgery

Study Arms (2)

Full visibility vnotes group

EXPERIMENTAL

A suitable size of multi-channel vaginal sealing instrument was inserted from the vagina, pneumoperitoneum formed air pressure, and the vaginal dome was dilated and fully exposed. The dome was opened under laparoscopy, and an approach platform was established to complete the total hysterectomy.

Device: Vnotes surgery using fully visualised surgical instruments

Traditional vnotes group

EXPERIMENTAL

The vaginal fornix and part of cervical ligaments were incised by vaginal operation, and an approach platform was established to complete hysterectomy.

Device: Vnotes surgery using traditional surgical instruments

Interventions

Vnotes surgery using fully visualised surgical instruments DEVICE

Vnotes surgery using fully visualised surgical instruments

Full visibility vnotes group

Vnotes surgery using traditional surgical instruments DEVICE

Vnotes surgery using traditional surgical instruments

Traditional vnotes group

Eligibility Criteria

• Age: Up to 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Patients known to have severe hepatic or renal dysfunction;
• Patients with known blood disorders, coagulation disorders, active bleeding at any site, or bleeding propensity;
• 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;
• patients with acute infection;
• Known to have participated in any other clinical trial or taken hormone therapy within 3 months;
• who cannot sign the informed consent;
• For those with known or suspected poor compliance who could not complete the trial.

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 086010, China

RECRUITING

MeSH Terms

Conditions

Myofibroma

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jing Liang, MD

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Liang, MD

CONTACT

8684206115; jacyliang@sina.com

Yuebo Li, MD

CONTACT

8684206115; yueboli@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Obstetrics and Gynecology

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: October 26, 2024
• Study Start: February 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 12, 2025

Record last verified: 2024-10

Locations

CN (1)