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

Key facts

Who runs it
West China Second University Hospital
Where
China1 site in 1 countryChoose a country to see its sites
Trial code
Status
Not yet recruiting
People taking part
210 people, planned
Started
1 Oct 2025
Expected to end
Oct 2028
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • TU-LESS
  • vNOTES
Record updated
18 September 2025

Who can take part

Age
18 years to 70 years
Sex
Women only
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • Eligible women aged 18-70 years
  • Women with indications for enlarged uterine volumes who are planning to under go total hysterectomy. Uterine size should exceed that of a 3-month pregnancy (uterine weight ≥ 280 g)
  • Patients are willing to be randomly assigned to undergo any of both approaches
  • Patients who are willing to sign the informed consent form

Who cannot take part

  • Patients requiring concurrent surgical intervention for conditions such as ovarian cysts or lesions of the vulva, vagina, appendix, etc
  • History of peritoneal dialysis, pelvic radiation therapy and pelvic tuberculosis treated with laparoscopic surgery
  • 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)
  • Diabetes mellitus with poor blood glucose control
  • Individuals who are virgins or have vaginal stenosis
  • presence of uterus exceeding approximately 20 gestational weeks in size (about 900-1000g), which is beyond the limitations of a single-site laparoscopic approach due to concerns regarding technical feasibility and safety
  • Patients with prolapse or pelvic inflammation
  • Body mass index greater than 30 kg/m²

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 70 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

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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.

The 2 groups in the trial

  • TU-LESS for hysterectomyExisting treatment, for comparison

    Patients diagnosed with enlarged uteri following a bimanual examination, with confirmation of the size and nature of the enlargement through imaging techniques such as ultrasound or magnetic resonance imaging (MRI).

    Treatment: TU-LESS

  • vNOTES for hysterectomyTreatment being tested

    Patients diagnosed with enlarged uteri following a bimanual examination, with confirmation of the size and nature of the enlargement through imaging techniques such as ultrasound or magnetic resonance imaging (MRI).

    Treatment: vNOTES

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Fit questions
Built from NCT06663553, who can take part
Record updated
18 September 2025