--- title: Comparing the Efficacy of TU-LESS and vNOTES for Hysterectomy of Enlarged Uterus nct_id: NCT06663553 overall_status: NOT_YET_RECRUITING phase: NA sponsor: West China Second University Hospital study_type: INTERVENTIONAL primary_condition: Enlarged Uterus countries: China canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06663553.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06663553" ct_last_update_post_date: 2025-09-18 last_seen_at: "2026-05-12T06:25:23.585Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Comparing the Efficacy of TU-LESS and vNOTES for Hysterectomy of Enlarged Uterus **Official 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 **NCT ID:** [NCT06663553](https://clinicaltrials.gov/study/NCT06663553) ## Key Facts - **Status:** NOT_YET_RECRUITING - **Phase:** NA - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 210 - **Lead Sponsor:** West China Second University Hospital - **Conditions:** Enlarged Uterus, Adenomyosis, Uterine Fibroids (UF) - **Start Date:** 2025-10-01 - **Completion Date:** 2028-10 - **CT.gov Last Update:** 2025-09-18 ## 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. ## Detailed Description 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. ## Eligibility - **Minimum age:** 18 Years - **Maximum age:** 70 Years - **Sex:** FEMALE - **Healthy Volunteers:** No ``` 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. ``` ## Arms - **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). - **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). ## Interventions - **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 - **postoperative liquid diet** _(time frame: within 24 hours postoperatively)_ — the proportion of patients able to consume a liquid diet post-surgery - **passing flatus** _(time frame: within 24 hours postoperatively)_ — the proportion of patients able to pass flatus - **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 - **ambulation** _(time frame: within 24 hours postoperatively)_ — The proportion of patients regaining mobility after catheter removal - **hospital stay** _(time frame: within 2 days postoperatively)_ — The percentage of patients discharged within 2 days after surgery - **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 - **Postoperative pain** _(time frame: at 12 hours and 24 hours postoperatively)_ - **The duration of operation** _(time frame: during operation)_ - **amount of bleeding** _(time frame: during operation)_ - **Intraoperative complications and postoperative complications** _(time frame: within 3 months)_ - **abdominal scars assessment** _(time frame: both at 3 and 6 months after surgery)_ - **the total dosage of analgesics taken** _(time frame: during the first 24 hours following surgery)_ - **The Female Sexual Function Index(FSFI)** _(time frame: both at baseline and 6 months after surgery)_ ## Locations (1) - West China Second University Hospital, Chengdu, Sichuan, China ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.west china second university hospital|chengdu|sichuan|china` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT06663553.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT06663553* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*