NCT06663553

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

Protocol for a Comparative Study of the Efficacy of Transumbilical Laparoendoscopic Single-site Surgery (TU-LESS) and Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) in Hysterectomy Performed on Patients With Enlarged Uterus: A Prospective Single-blinded, Randomized Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: West China Second University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Enlarged uterus is frequently encountered in clinical practice, and its incidence due to conditions such as adenomyosis, uterine fibroids, and other gynecological disorders has steadily increased over the years statistically. For example, greater healthcare awareness has led to more frequent early diagnoses of these conditions, contributing to the observed rise in incidence. Additionally, increasing life expectancy results in more women reaching the perimenopausal and postmenopausal stages, during which conditions like uterine fibroids and adenomyosis become more prevalent. For these women, hysterectomy (removal of the entire uterus) is often the recommended option of treatment. With advances in surgical techniques over recent decades, there has been a notable shift from traditional open abdominal surgeries to minimally invasive approaches. Laparoscopic surgery has been widely adopted, significantly reducing the size and number of incisions required, thereby promoting faster recovery, minimizing postoperative pain, and reducing the risk of complications. However, conventional multi-port laparoscopic hysterectomy still presents certain challenges, such as large uterus extraction following resection, and concerns about healing of incisions. In contrast, innovative techniques like Transumbilical Laparoendoscopic Single-Site Surgery(TU-LESS) and Transvaginal Natural Orifice Transluminal Endoscopic Surgery(vNOTES) both take advantage of natural anatomical openings to achieve minimal or no visible scarring. Studies demonstrate that these techniques provide superior outcomes in terms of reduced pain, faster recovery, and quicker return to daily activities compared to traditional multi-port laparoscopic approaches. Yet a direct comparison of the efficacy of these two methods in real-world, particularly for enlarged uterus, remains inconclusive. Thus this study aims to evaluate and compare the outcomes of these two techniques in patients with enlarged uteri. Participants will be randomly assigned to receive one of the two surgical approaches, ensuring an unbiased comparison of the efficacy of the procedures in terms of healing status and recovery time.

Detailed description

Enlarged uterus, mainly caused by adenomyosis, is often associated with symptoms like compression of intestines and urethra(presenting as constipation, urinary frequency, and urgency), dysmenorrhea, menstrual irregularity, and anemia due to menorrhagia. A hysterectomy (removal of the uterus) is often recommended, especially in cases where conservative management like medical treatment fails. Among all the methods of hysterectomy, TU-LESS and vNOTES are noted for minimized invasiveness and fast recovery. As vNOTES is performed through the vagina and TU-LESS involves a single incision through the umbilicus, they both utilize natural anatomical openings, resulting in minimal to no visible scarring.

Conditions

• Enlarged Uterus
• Adenomyosis
• Uterine Fibroids (UF)

Interventions

Type	Name	Description
PROCEDURE	TU-LESS	patients in TU-LESS group will receive transumbilical laparoendoscopic single-site surgery (TU-LESS) for hysterectomy
PROCEDURE	vNOTES	patients in vNOTES group will receive transvaginal natural orifice transluminal endoscopic surgery (TU-LESS) for hysterectomy

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-10-01
• Completion: 2028-10-01
• First posted: 2024-10-29
• Last updated: 2025-09-18

Locations

1 site across 1 country: China