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A randomized controlled, open clinical study comparing the safety and efficacy of transvaginal natural orifice transluminal endoscopic surgery (VNOTES) and single-port transumbilical total laparoscopic hysterectomy

A randomized controlled, open clinical study comparing the safety and efficacy of transvaginal natural orifice transluminal endoscopic surgery (VNOTES) and single-port transumbilical total laparoscopic hysterectomy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075260
Enrollment
Unknown
Registered
2023-08-31
Start date
2023-08-31
Completion date
Unknown
Last updated
2023-09-04

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

Conditions

? Adenomyosis/endometriosis

Interventions

VNOTES group:Total hysterectomy by transvaginal natural orifice transluminal endoscopic surgery (VNOTES)
LESS group:Total hysterectomy by single-port transumbilical total laparoscopic hysterectomy (LESS)

Sponsors

Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
19 Years to 74 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: =18 years old, < 75 years old, female patients with indications of hysterectomy due to benign diseases according to clinical guidelines, the surgical indications included: ? adenomyopathy/endometriosis; ? Uterine fibroids; ? cervical intraepithelial lesions; ? Atypical endometrial hyperplasia; ? Other conditions requiring hysterectomy.

Exclusion criteria

Exclusion criteria: ? Pelvic inflammatory disease; (2) Active infection of reproductive tract; ? Advanced tumor; ? History of rectal surgery; ? rectal endometriosis; ? uterine prolapse; ? No sex life; ? History of cesarean section twice or more; ? Pregnancy; ? Mentally unable to cooperate.

Design outcomes

Primary

MeasureTime frame
Intraoperative and postoperative complications;

Secondary

MeasureTime frame
Hemoglobin before and after surgery;Pain intensity;Satisfaction;

Countries

China

Contacts

Public ContactWeihua Lou

Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

13701911566@139.com+86 137 0191 1566

Outcome results

None listed

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