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Efficacy and safety of transvaginal single-port laparoscopic (vNOTES) hysterectomy without pneumoperitoneum versus artificial pneumoperitoneum: a prospective randomized controlled study

Efficacy and safety of transvaginal single-port laparoscopic (vNOTES) hysterectomy without pneumoperitoneum versus artificial pneumoperitoneum: a prospective randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054349
Enrollment
Unknown
Registered
2021-12-14
Start date
2022-01-01
Completion date
Unknown
Last updated
2022-11-14

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

Conditions

None listed

Interventions

Group 1:Total hysterectomy without pneumoperitoneum vNOTES
Group 2:Total hysterectomy under artificial pneumoperitoneum vNOTES

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. Patients aged 30-70 who intend to undergo total hysterectomy in our hospital due to ''benign gynecological diseases''; 2. Pregnant women who voluntarily participated in the survey with informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who are unable to participate in the survey due to mental illness or physical disability/disability; 2. Patients with contraindications to vNOTES surgery; 3. Cardiopulmonary insufficiency is not suitable for laparoscopic surgery with pneumoperitoneum; 4. Those with malignant tendency of uterus and appendages; 5. Body mass index (BMI) greater than 30kg/m^2.

Design outcomes

Primary

MeasureTime frame
Surgical success rate;

Secondary

MeasureTime frame
Operation time;Intraoperative blood loss;Intraoperative CO2 intake;Visual analogue scale pain score after surgery;Postoperative nausea/vomiting;Satisfaction of postoperative of life;Length of stay;Hospitalization expenses;Postoperative changes in hemoglobin;Intraoperative mean arterial pressure changes;Postoperative first exhaust time;Postoperative complications;

Countries

China

Contacts

Public ContactHe Li

Chengdu Women and Children's Central Hospital

helisc@163.com+86 13881782966

Outcome results

None listed

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