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The Comparison of the efficacy and safety of three surgical approaches for laparoscopic total hysterectomy: a multicenter, randomized, single-blind, parallel controlled trial

The Comparison of the efficacy and safety of three surgical approaches for laparoscopic total hysterectomy: a multicenter, randomized, single-blind, parallel controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200057405
Enrollment
Unknown
Registered
2022-03-11
Start date
2022-05-06
Completion date
Unknown
Last updated
2023-10-16

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

Conditions

disease of uterus

Interventions

vNOTES:trans-vaginal natural orifice transluminal endoscopic total hysterectomy
TU-LESS:trans-umbilical laparoendoscopic single site surgery
conventional laparoscopic surgery:conventional laparoscopy

Sponsors

Department of Obstetrics and Gynecology, West China Second University Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1.18-60 year old female; 2. Indications for total hysterectomy (hysteromyoma, adenomyosis, cervical precancerous lesions, endometrial atypical hyperplasia, cervical adenocarcinoma in situ), and total hysterectomy is planned; 3. The patients participating in the study recognized three surgical routes and were willing to accept any one of the three at random; 4. Sign the operation consent voluntarily; 5. The score of ECOG function is greater than 1 point.

Exclusion criteria

Exclusion criteria: 1. Asexual life; 2. The cyst should be removed at the same time or combined with other vulva, vagina, appendix and other diseases, and surgical intervention is required at the same time; 3. Malignant tumor or highly suspicious malignant tumor; 4. History of two or more pelvic operations, severe pelvic adhesions (suspected of rectal endometriosis, or poor uterine activity); 5. History of peritoneal dialysis, pelvic radiotherapy, and previous history of pelvic laparoscopic tuberculosis; 6. Uterus > 3 months of pregnancy (ultrasound indicates that the maximum diameter of the uterus is greater than 12 cm); 7. diabetes with poor blood sugar control; 8.BMI>30Kg/m2 9. Patients with poor compliance or far distance from enough follow-up.

Design outcomes

Primary

MeasureTime frame
Enhanced recovery index achievement rate after surgery within 24 hours;

Secondary

MeasureTime frame
operative time;estimated blood loss;conversion;postoperative passing flatus;postoperative activity time;postoperative urination time;postoperative fluid intake time;time of postoperative VAS score=3;intraoperative and postoperative complication;postoperative VAS score at 12h and 24h;Postoperative analgesics usage;postoperative readmission rate within 3 month;cosmetic satisfaction;Sexual satisfaction;

Countries

China

Contacts

Public ContactYing Zheng

Department of Obstetrics and Gynecology, West China Second Hospital, Sichuan University

zhy_chd@126.com+86 13018256012

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026