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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorWest China Second University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 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

Presence of malignancy or strong suspicion of malignancy that may alter the planned surgical approach.

Trial design

Design model

Parallel

Treatments tested in this trial

  • TU-LESS

    Procedure/Surgery

    patients in TU-LESS group will receive transumbilical laparoendoscopic single-site surgery (TU-LESS) for hysterectomy

  • vNOTES

    Procedure/Surgery

    patients in vNOTES group will receive transvaginal natural orifice transluminal endoscopic surgery (TU-LESS) for hysterectomy

Treatment groups

210 Participants
are divided into 2 treatment groups
Group A: TU-LESS for hysterectomyActive comparator 1 intervention
Group B: vNOTES for hysterectomyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

postoperative liquid diet

the proportion of patients able to consume a liquid diet post-surgery

Time frame
within 24 hours postoperatively
2

passing flatus

the proportion of patients able to pass flatus

Time frame
within 24 hours postoperatively
3

self-urination after catheter removal

The proportion of patients regaining the ability to urinate without assistance after catheter removal

Time frame
within 24 hours postoperatively
4

ambulation

The proportion of patients regaining mobility after catheter removal

Time frame
within 24 hours postoperatively

Secondary outcomes

1

Postoperative pain

It is measured by the VAS score. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').

Time frame
at 12 hours and 24 hours postoperatively
2

The duration of operation

It will be measured in min utes, starting from the initiation of the skin (or vag inal) incision and concluding upon the completion of the skin (or vaginal) suturing. If a frozen biopsy is needed during the operation, the increased time for the frozen biopsy should be subtracted. However, pa tients for whom the surgical method is changed due to the result of the frozen biopsy should be excluded.

Time frame
during operation
3

amount of bleeding

Time frame
during operation
4

Intraoperative complications and postoperative complications

We use the Clavien-Dindo classification to rank a complication in an objective and reproducible manner. It consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V). The introduction of the subclasses a and b allows a contraction of the classification into 5 grades (I, II, III, IV and V) depending on the size of the population observed or the of the focus of a study.

Time frame
within 3 months

Other outcomes

Sponsors and contacts

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