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

NCT06663553 | Not Yet Recruiting

• 1 other identifier: 2020079JHY
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Enlarged Uterus; Adenomyosis; Uterine Fibroids (UF)

Outcome Measures

Primary Outcomes (6)

• postoperative liquid diet

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

  within 24 hours postoperatively

• passing flatus

  the proportion of patients able to pass flatus

  within 24 hours postoperatively

• self-urination after catheter removal

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

  within 24 hours postoperatively

• ambulation

  The proportion of patients regaining mobility after catheter removal

  within 24 hours postoperatively

• hospital stay

  The percentage of patients discharged within 2 days after surgery

  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.

  within 2 days postoperatively

Secondary Outcomes (7)

• Postoperative pain

  at 12 hours and 24 hours postoperatively

• The duration of operation

  during operation

• amount of bleeding

  during operation

• Intraoperative complications and postoperative complications

  within 3 months

• abdominal scars assessment

  both at 3 and 6 months after surgery

Study Arms (2)

TU-LESS for hysterectomy

ACTIVE COMPARATOR

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

vNOTES for hysterectomy

EXPERIMENTAL

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

Interventions

TU-LESS PROCEDURE

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

TU-LESS for hysterectomy

vNOTES PROCEDURE

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

vNOTES for hysterectomy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: Enlarged uterine volumes occur only to female population
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Second University Hospital: lead

Study Sites (1)

West China Second University Hospital

Chengdu, Sichuan, 610041, China

Location

Related Publications (3)

• Benassi L, Rossi T, Kaihura CT, Ricci L, Bedocchi L, Galanti B, Vadora E. Abdominal or vaginal hysterectomy for enlarged uteri: a randomized clinical trial. Am J Obstet Gynecol. 2002 Dec;187(6):1561-5. doi: 10.1067/mob.2002.127596.

  PMID: 12501064 BACKGROUND

• Zhang W, Deng L, Yang F, Liu J, Chen S, You X, Gou J, Zi D, Li Y, Qi X, Wang Y, Zheng Y. Comparing the efficacy and safety of three surgical approaches for total hysterectomy (TSATH): protocol for a multicentre, single-blind, parallel-group, randomised controlled trial. BMJ Open. 2024 Jan 10;14(1):e074478. doi: 10.1136/bmjopen-2023-074478.

  PMID: 38199630 BACKGROUND

• Chen X, Zhang M, Gao M, Wu Y, He Y, Liu J, Cui H, Jin H. Protocol for a study comparing the efficacy of hysterectomy in patients with enlarged uterus via TU-LESS and vNOTES: a single-blind, prospective randomised clinical trial. BMJ Open. 2025 Nov 26;15(11):e103174. doi: 10.1136/bmjopen-2025-103174.

  PMID: 41298256 DERIVED

MeSH Terms

Conditions

Adenomyosis; Leiomyoma

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will remain blinded to their surgical methods in 24 hours following the operation. To achieve this, we will apply wound pads to each patient's abdomen as the wounds typically seen in tradi tional laparoscopy procedures, no matter whether actual wounds exist.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer and gynecological surgeon

Study Record Dates

• First Submitted: October 19, 2024
• First Posted: October 29, 2024
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2028
• Last Updated: September 18, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

CN (1)