Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06663553 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Eligibility criteria expanded, about 8 words
    • Publications: details revised at 2 of 3 entries
    v3
  2. Notable Start date: Dec 2024 to Oct 1, 2025
    • Eligibility criteria expanded, about 16 words
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06663553
Lead Sponsor West China Second University Hospital
Conditions
(from sponsor)
Enlarged Uterus, Adenomyosis, Uterine Fibroids (UF)
Related terms Adenomyosis, Leiomyoma
Enrollment 210 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov