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A randomized controlled trial for the efficacy and safety of prone split leg position and bladder lithotomy position in posterior myomectomy of uterus in vaginal natural orifice transluminal endoscopic surgery (v-notes)

A randomized controlled trial for the efficacy and safety of prone split leg position and bladder lithotomy position in posterior myomectomy of uterus in vaginal natural orifice transluminal endoscopic surgery (v-notes)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037953
Enrollment
Unknown
Registered
2020-09-06
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-11-16

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

Conditions

Fibroid

Interventions

Control group:bladder lithotomy position
Experimental group:prone split leg position

Sponsors

Chengdu Women's and Children's Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 56 Years

Inclusion criteria

Inclusion criteria: 1. Patients who meet the following conditions: (1) For patients with single or multiple subserosal leiomyomas, the largest diameter of myoma is less than or equal to 10 cm; (2) In patients with single or multiple intramural leiomyomas of the posterior wall of the uterus, the diameter of the myoma was greater than or equal to 4 cm, but less than or equal to 10 cm; (3) Patients with multiple leiomyomas had no more than 4 leiomyomas; (4) The possibility of malignant transformation of myoma was excluded before operation; (5) The patient asked to keep the uterus; (6) There was no obvious pelvic adhesion; (7) The largest diameter of myoma was less than 10 cm. 2. Patients with stable vital signs could tolerate laparoscopic surgery; 3. Patients or family members can understand the study protocol and are willing to participate in the study and provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with uterine leiomyoma diameter > 10 cm; more than 4 leiomyomas, more than 4 with diameter > 3 cm; uterine fibroids with diameter less than 3 cm grow into uterine cavity, and 30% of them protrude into uterine cavity; obesity; suspected adenomyosis; uterine enlargement exceeding the size of 16 weeks of pregnancy; 2. Patients in acute infection stage had deep venous thrombosis or hypercoagulable state, fasting blood glucose > 11.1mmol/l, blood pressure > 160 / 100mmhg, liver and kidney dysfunction, mental disease and other surgical contraindications; 3. Patients with a history of rectal surgery were suspected of rectovaginal septum endometriosis or tumor; 4. In patients with severe pelvic adhesions, the bowel may be damaged by transvaginal approach; 5. Patients with asexual life history.

Design outcomes

Primary

MeasureTime frame
perioperative complication;

Secondary

MeasureTime frame
Operation time;intraoperative blood loss;postoperative exhaust time;

Countries

China

Contacts

Public ContactHe Li

Chengdu Women's and Children's Central Hospital

helisc@163.com+86 19136130580

Outcome results

None listed

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