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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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

Study 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.

Eligibility

Primary outcome measure(s)

• postoperative liquid diet — within 24 hours postoperatively
  the proportion of patients able to consume a liquid diet post-surgery
• passing flatus — within 24 hours postoperatively
  the proportion of patients able to pass flatus
• self-urination after catheter removal — within 24 hours postoperatively
  The proportion of patients regaining the ability to urinate without assistance after catheter removal
• ambulation — within 24 hours postoperatively
  The proportion of patients regaining mobility after catheter removal
• hospital stay — within 2 days postoperatively
  The percentage of patients discharged within 2 days after surgery
• examination of pelvic fuction — 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.

Trial sites (1)

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