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NCT Number: NCT06663553

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

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.

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Key information

Conditions

Enlarged Uterus Adenomyosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Leiomyoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Urogenital Diseases Uterine Diseases Uterine Fibroids (UF)

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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 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.
  • 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.
  • Patients with prolapse or pelvic inflammation.
  • Diabetes mellitus with poor blood glucose control.
  • Body mass index greater than 30 kg/m².

Treatment and study plan

TU-LESS

Procedure

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

vNOTES

Procedure

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

Primary outcomes

  1. postoperative liquid diet

    Time frame: within 24 hours postoperatively

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

  2. passing flatus

    Time frame: within 24 hours postoperatively

    the proportion of patients able to pass flatus

  3. self-urination after catheter removal

    Time frame: within 24 hours postoperatively

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

  4. ambulation

    Time frame: within 24 hours postoperatively

    The proportion of patients regaining mobility after catheter removal

  5. hospital stay

    Time frame: within 2 days postoperatively

    The percentage of patients discharged within 2 days after surgery

  6. examination of pelvic fuction

    Time frame: within 2 days postoperatively

    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.

Secondary outcomes

  1. Postoperative pain

    Time frame: at 12 hours and 24 hours postoperatively

    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').

  2. The duration of operation

    Time frame: during 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.

  3. amount of bleeding

    Time frame: during operation

  4. Intraoperative complications and postoperative complications

    Time frame: within 3 months

    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.

  5. abdominal scars assessment

    Time frame: both at 3 and 6 months after surgery

    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.

  6. the total dosage of analgesics taken

    Time frame: during the first 24 hours following surgery

    also categorized by analgesic type

  7. The Female Sexual Function Index(FSFI)

    Time frame: both at baseline and 6 months after surgery

    Using either a paper sheet or online questionnaire

Sponsors and collaborators

Lead sponsor

West China Second University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Oct 29, 2024
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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