An interventional study of TU-LESS and vNOTES in Enlarged Uterus, Adenomyosis and Uterine Fibroids (UF), sponsored by West China Second University Hospital. Not yet recruiting at 1 site in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-09-18.
Sponsored by West China Second University Hospital · Not applicable, Interventional, and Treatment
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.
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.
135 studies on the registry are indexed under Adenomyosis; 50 are open to participants now.
This study's planned enrollment of 210 is above the median of 100 across 73 interventional studies indexed under Adenomyosis.
Browse Adenomyosis studies →West China Second University Hospital is the lead sponsor of 37 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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).
Procedure: TU-LESS
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).
Procedure: vNOTES
patients in TU-LESS group will receive transumbilical laparoendoscopic single-site surgery (TU-LESS) for hysterectomy
patients in vNOTES group will receive transvaginal natural orifice transluminal endoscopic surgery (TU-LESS) for hysterectomy
postoperative liquid diet
the proportion of patients able to consume a liquid diet post-surgery
Time frame: within 24 hours postoperatively
passing flatus
the proportion of patients able to pass flatus
Time frame: within 24 hours postoperatively
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
ambulation
The proportion of patients regaining mobility after catheter removal
Time frame: within 24 hours postoperatively
hospital stay
The percentage of patients discharged within 2 days after surgery
Time frame: within 2 days postoperatively
examination of pelvic fuction
The assessment of pelvic floor function involves evaluating Stress Urinary Incontinence (SUI), Pelvic Organ Prolapse (POP) and Sexual Dysfunction. The PISQ-IR (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire) is a validated tool specifically designed to evaluate sexual function in the context of pelvic floor. It is a tool that measures sexual function specifically for women affected by pelvic floor disorders, such as urinary incontinence and pelvic organ prolapse.
Time frame: within 2 days postoperatively
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
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
amount of bleeding
Time frame: during operation
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
abdominal scars assessment
The Patient and Observer Scar Assessment Scale (POSAS) will be used. It consists of two separate scales: the Patient Scale and the Observer Scale and measures scar quality (i.e. how the scar looks and feels) from both perspectives. The observer scores six items: vascularization, pigmentation, thickness, surface roughness, pliability, and surface area. The patient scores six items: pain, pruritus, color, thickness, relief, and pliability. All included items are scored on the same polytomous 10-point scale, in which a score of 1 is given when the scar characteristic is akin to 'normal skin' and a score of 10 reflects the 'worst imaginable scar'. All items are summed to give a total scar score, and therefore, a higher score represents a poorer scar quality.
Time frame: both at 3 and 6 months after surgery
the total dosage of analgesics taken
also categorized by analgesic type
Time frame: during the first 24 hours following surgery
The Female Sexual Function Index(FSFI)
Using either a paper sheet or online questionnaire
Time frame: both at baseline and 6 months after surgery
Plan to share: Yes
Supporting information: Study protocol, Icf
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West China Second University Hospital