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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 total hysterectomy

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 total hysterectomy

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036517
Enrollment
Unknown
Registered
2020-08-23
Start date
2020-09-01
Completion date
Unknown
Last updated
2020-09-14

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

Group 1:Transvaginal Natural Orifice Transluminal Endoscopic Surgery (V-NOTES) in the total hysterectomy
Group 2:Laparo-endoscopic Single-Site Surgery (TU-LESS) in the total hysterectomy

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

Inclusion criteria

Inclusion criteria: 1. Patients over 18 years old; 2. Patients with uterine fibroids, adenomyosis, endometrial lesions, pelvic organ prolapse, endometrial cancer or cervical precancerous lesions, and some early gynecologic malignant tumors need hysterectomy. 3. The patients with stable vital signs can tolerate laparoscopic surgery; 4. Patients were able to understand the protocol and willing to participate in the study, and provided written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with severe internal and external complications, fasting blood glucose > 11.1mmol/l, blood pressure > 160 / 100mmhg, liver and kidney dysfunction, cardiovascular and cerebrovascular diseases, acute infection stage, preoperative deep venous thrombosis or hypercoagulable state, mental illness and other surgical contraindications; 2. Patients with history of rectal surgery were suspected of rectovaginal septum endometriosis or tumor; 3. Patients with asexual life history; 4. Pregnancy. 5. Others: pelvic inflammatory disease, multiple abdominal surgery history, preoperative evaluation is not suitable for laparoscopic surgery.

Design outcomes

Primary

MeasureTime frame
Perioperative complications;

Secondary

MeasureTime frame
Duration of operation;Intraoperative blood loss;The weight of uterus;The time of postoperative anal exhaust;The time of get out of bed;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