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A non-randomized controlled trial on the efficacy and safety of transvaginal endoscopic surgery (vNOTES) and transumbilical laparoscopic surgery (LESS) for sentinel lymphadenectomy of endometrial carcinoma

A non-randomized controlled trial on the efficacy and safety of transvaginal endoscopic surgery (vNOTES) and transumbilical laparoscopic surgery (LESS) for sentinel lymphadenectomy of endometrial carcinoma

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000038615
Enrollment
Unknown
Registered
2020-09-26
Start date
2020-11-01
Completion date
Unknown
Last updated
2020-12-07

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

Conditions

Endometrial carcinoma

Interventions

Group A:laparoendoscopic single site surgery
Group B:natural orifice transvaginal endoscopic 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
30 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. The subjects voluntarily join the study and signed the informed consent; 2. Women aged 35-60 who are diagnosed as endometrial cancer by pathology were not pregnant and have no reproductive requirements; 3. The researcher believes that the subjects can comply with the study plan; 4. No other clinical trials were conducted 3 months before the subject enter our clinical trial; 5. The subject can tolerate anesthesia without serious basic disease; 6. The previous operation history of pelvic and abdominal cavity should be less than 2 times 7. Subjects should be without vaginitis; 8. Preoperative vagina examination in patients predicts no severe adhesions in pelvic cavity and upper abdominal cavity.

Exclusion criteria

Exclusion criteria: 1. Patients with fertility requirements; 2. Patients participated in other clinical trials within 3 months before this clinical trial; 3. Patients with severe basic diseases who can't tolerate surgery or anesthesia; 4. Patients who have had more than 2 previous abdominal or pelvic operations; 5. Patients with vaginitis or no improvement after treatment; 6. Preoperative vaginal examination in patients with severe adhesion of pelvic or abdominal cavity; 7. Patients with active infection of other organs; 8. Known presence of mental illness or substance abuse that may affect compliance with test requirements 9. Patients with human immunodeficiency virus (HIV) infection; 10. Patients with other factors that researchers consider unsuitable for this clinical trial.

Design outcomes

Primary

MeasureTime frame
progression free survival;overall survival time;Positive rate of lymph nodes;5-year survival;

Secondary

MeasureTime frame
Complications;operative bleeding volume;operative time;Postoperative pain;Recovery of micturition and defecation time after operation;Hospitalization expenses;Length of hospital stay after operation;

Countries

China

Contacts

Public ContactLi He

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

helisc@163.com+86 13881782966

Outcome results

None listed

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