About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
TU-LESS
Procedure/Surgerypatients in TU-LESS group will receive transumbilical laparoendoscopic single-site surgery (TU-LESS) for hysterectomy
vNOTES
Procedure/Surgerypatients in vNOTES group will receive transvaginal natural orifice transluminal endoscopic surgery (TU-LESS) for hysterectomy
Treatment groups
Trial outcomes
Primary outcomes
postoperative liquid diet
the proportion of patients able to consume a liquid diet post-surgery
passing flatus
the proportion of patients able to pass flatus
self-urination after catheter removal
The proportion of patients regaining the ability to urinate without assistance after catheter removal
ambulation
The proportion of patients regaining mobility after catheter removal
Secondary outcomes
Postoperative pain
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').
The duration of 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.
amount of bleeding
Intraoperative complications and postoperative complications
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.
Sponsors and contacts
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