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A prospective single arm trial of gasless vNOTES hysterectomy assisted by a laparoscopic single-port surgical system

A prospective single arm trial of gasless vNOTES hysterectomy assisted by a laparoscopic single-port surgical system

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086932
Enrollment
Unknown
Registered
2024-07-15
Start date
2024-07-20
Completion date
Unknown
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gynecological diseases

Interventions

Trial group:Performed laparoscopic single-port surgical system-assisted gasless vNOTES total hysterectomy

Sponsors

Chengdu Women and Children's Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
30 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Female aged 30-70 years old. 2) Patients who require total hysterectomy. 3) Patients with ASA grade I-III. 4) Able to cooperate with the completion of the visits and related examinations specified in the program. 5) The subject voluntarily participates in the clinical trial and agrees or the guardian agrees to sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Those who have undergone other major surgical treatments within 3 months prior to enrollment and plan to undergo other major surgical treatments during the trial period, or those who are unable to recover from the side effects of any such surgery. 2) Patients with active tuberculosis. 3) Immunodeficiency virus (HIV) antibody positive; Hepatitis C virus (HCV) antibody positive; Patients who are positive for Treponema pallidum antibodies and are judged by the investigator to be at high risk of infection. 4) Those with severe systemic diseases, which are judged by the investigator to be unsuitable for surgical treatment. 5) Patients who have been using anticoagulant and antiplatelet drugs for a long time (antiplatelet aggregation drugs have been stopped for less than 1 week before surgery), and have a history of bleeding disorders or hematopoietic dysfunction or coagulation dysfunction. 6) Those who have participated in other interventional clinical trials within 3 months before screening. 7) Other conditions that the investigator considers inappropriate to participate in this trial.

Design outcomes

Primary

MeasureTime frame
Surgical success rate;

Secondary

MeasureTime frame
Duration of surgery;Intraoperative blood loss;Positive rate of surgical margins;Length of postoperative hospital stay;Postoperative pain score;Physician satisfaction surveys;Adverse event;Intraoperative complications;Postoperative complications;

Countries

China

Contacts

Public ContactLin Yonghong

Chengdu Women and Children's Central Hospital

linyhcd2011@163.com+86 138 0803 1895

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026