Comparing the Efficacy of TU-LESS and VNOTES for Hysterectomy of Enlarged Uterus

Launched by WEST CHINA SECOND UNIVERSITY HOSPITAL · Oct 27, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two different surgical methods, TU-LESS and VNOTES, for women who need a hysterectomy due to an enlarged uterus caused by conditions like adenomyosis or uterine fibroids. Both techniques are minimally invasive, meaning they use smaller incisions or even natural openings in the body, which can lead to less pain and faster recovery compared to traditional surgery that requires larger cuts. The goal is to find out which method works better for patients in terms of healing and getting back to their normal activities.

To participate in this trial, women aged 18 to 70 who are facing surgery for an enlarged uterus are eligible. Participants will be randomly assigned to one of the two surgical methods, ensuring a fair comparison of their effectiveness. It's important to note that certain women, such as those with specific medical conditions or prior surgeries, may not qualify for the study. If you choose to participate, you will be closely monitored throughout the process, providing valuable information to help improve surgical options for future patients.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Eligible women aged 18-70 years.
• • Women with indications for enlarged uterine volumes who are planning to under go total hysterectomy.
• • Patients are willing to be randomly assigned to undergo any of both approaches.
• • Patients who are willing to sign the informed consent form.
• Exclusion Criteria:
• • Individuals who are virgins or have vaginal stenosis.
• • Patients requiring concurrent surgical intervention for conditions such as ovarian cysts or lesions of the vulva, vagina, appendix, etc.
• • Presence of malignancy or strong suspicion of malignancy that may alter the planned surgical approach.
• • History of two or more pelvic surgeries or suspected severe pelvic adhesions (rectovaginal examination suggesting rectovaginal endometriosis or limited uterine mobility).
• • History of peritoneal dialysis, pelvic radiation therapy and pelvic tuberculosis treated with laparoscopic surgery.
• • Uterine size exceeding that of a 3-month pregnancy (ultrasound indicates that the maximum uterine diameter line is greater than 12cm).
• • Patients with prolapse or pelvic inflammation.
• • Diabetes mellitus with poor blood glucose control.
• • Body mass index greater than 30 kg/m².