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A randomized controlled study for the efficacy and safety of transvaginal natural orifice transluminal endoscopic surgery and transumbilical laparo-endoscopic single-site surgery for benign ovarian tumors

A randomized controlled study for the efficacy and safety of transvaginal natural orifice transluminal endoscopic surgery(V-NOTES) and transumbilical laparo-endoscopic single-site surgery(TU-LESS)for benign ovarian tumors

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900025986
Enrollment
Unknown
Registered
2019-09-16
Start date
2019-11-01
Completion date
Unknown
Last updated
2019-09-30

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

Conditions

diseases of obstetrics and gynecology

Interventions

1:Transvaginal Natural Orifice Transluminal Endoscopic Surgery (V-NOTES)
2:transumbilical laparo-endoscopic single-site surgery

Sponsors

Chengdu Women's and Children's Central Hospital, School of Medicine, University of Electronic Science and Technology of China
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Women older than 18 years; 2. Laparoscopic surgery is required for benign ovarian tumors; 3. The vital signs are stable and can be tolerated by laparoscopy; 4. Patients can understand the research program and are willing to participate in this study, providing written informed consent.

Exclusion criteria

Exclusion criteria: 1. Acute infection stage, preoperative deep venous thrombosis or hypercoagulability, fasting blood sugar > 11.1 mmol/L, blood pressure > 160/100 mmHg, liver and kidney dysfunction, mental illness and other surgical contraindications; 2. History of rectal surgery, suspected of rectovaginal septum endometriosis or tumors; 3. virginity; 4. Pregnancy.

Design outcomes

Primary

MeasureTime frame
Perioperative complications;

Secondary

MeasureTime frame
Visual analogue scale;Anti-Mullerian Hormone (AMH) 1 month after operation;average length of stay;Patient Satisfaction;Hospitalization expenses;Use rate of analgesics;Post Operative Nausea And Vomitting;Body Image Scale/Cosmetic Scale;

Countries

China

Contacts

Public ContactYonghong Lin

Chengdu Women's and Children's Central Hospital, School of Medicine, University of Electronic Science and Technology of China

linyh.2007@aliyun.com+86 13808031895

Outcome results

None listed

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